Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure
- NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation.
- 04/02/2025
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First Three Children to Commence Treatment With Ryoncil®
- United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage
- 03/30/2025
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Ryoncil® is Now Available for Purchase in the United States
- NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Ryoncil® (remestemcel-L) the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, is now available for purchase in the United States.
- 03/26/2025
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Ryoncil® Product Information Now Available in All Four Major Drug Pricing Compendia in United States
- NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that pricing information for Ryoncil® is now available in all four major drug pricing compendia in the United States. These pricing compendia provide the official source for all information required to order product, including product manufacturing details, National Drug Codes (NDC) for kit purchase, and kit pricing.
- 03/13/2025
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Mesoblast CEO to Deliver Featured Presentation at ISCT North America Virtual Town Hall
- NEW YORK, March 12, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that Chief Executive Silviu Itescu will deliver the Featured Presentation at the International Cell & Gene Therapy (ISCT) North America Regional Virtual Town Hall at 4.00pm EDT, Wednesday, March 12th; 7.00am AEDT, Thursday, March 13th, 2025.
- 03/12/2025
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Mesoblast Limited (MESO) Q2 2025 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q2 2025 Earnings Conference Call February 26, 2025 5:00 PM ET Company Participants Silviu Itescu - Chief Executive Officer & Managing Director Andrew Chaponnel - Interim Chief Financial Officer Marcelo Santoro - Chief Commercial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Michael Okunewitch - Maxim Group Silviu Itescu Good morning, everybody. I'm Silviu Itescu.
- 02/28/2025
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Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment With Planned Product Availability This Quarter
- Financial Results and Operational Update for Half-Year Ended December 31, 2024 Financial Results and Operational Update for Half-Year Ended December 31, 2024
- 02/26/2025
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Mesoblast Limited (MESO) Could Find a Support Soon, Here's Why You Should Buy the Stock Now
- Mesoblast Limited (MESO) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.
- 02/26/2025
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Mesoblast Financial Results and Corporate Update Webcast
- NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the half year ended December 31, 2024.
- 02/25/2025
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Dr. Gregory George MD PhD Joins Mesoblast Board
- NEW YORK, Feb. 23, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Dr. Gregory George MD PhD, Mesoblast's largest shareholder, to its Board of Directors.
- 02/23/2025
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Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
- NEW YORK, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its recently approved product Ryoncil® (remestemcel-L) is being highlighted at the 2025 Transplantation & Cellular Therapy Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), the industry's premier conference taking place this week in Honolulu, HI.
- 02/13/2025
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Ryoncil® Commercial Launch Update and Product Pipeline
- NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the progress of the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older and key upcoming milestones for its late-stage pipeline.
- 01/30/2025
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Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024
- NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second quarter ended December 31, 2024.
- 01/30/2025
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MESO Stock Surges 80% in a Month After FDA Approval of GVHD Drug
- Mesoblast stock climbs 80% in a month following the FDA's approval of Ryoncil as the only approved therapy for SR-aGVHD in children aged two months and older.
- 01/03/2025
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What Awaits These 4 Biotech Stocks That More Than Doubled in 2024
- Here are four drug and biotech stocks, ARQT, MESO, MNPR and KOD, which have more than doubled in 2024 with room for further growth in 2025.
- 12/26/2024
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MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease
- The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares rise.
- 12/19/2024
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Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges
- On Wednesday, the FDA approved Mesoblast Limited's MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.
- 12/19/2024
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Mesoblast's RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy
- NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil® (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents and teenagers.
- 12/18/2024
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Top-Notch Biotech Mesoblast Skyrockets 29% On Immune Condition Approval
- Mesoblast snagged FDA approval late Wednesday for the first-ever treatment for children with a form of GVHD. The biotech stock rocketed.
- 12/18/2024
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US FDA approves Mesoblast's cell therapy for graft-versus-host disease
- The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease.
- 12/18/2024
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Mesoblast to be Added to Nasdaq Biotechnology Index
- NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024.
- 12/18/2024
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FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease
- Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease
- 12/04/2024
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Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation
- Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy
- 12/02/2024
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Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024
- NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2024.
- 10/30/2024
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Mesoblast: Undervalued Due To Remestemcel-L's Substantial Growth Potential
- Mesoblast Limited is advancing innovative cellular therapies, with Remestemcel-L for pediatric SR-aGVHD nearing FDA approval and a PDUFA date set for January 2025. Positive Phase 3 results indicate that Remestemcel-L significantly improves response rates and survival in pediatric patients. Additionally, Mesoblast's pipeline includes late-stage therapies for chronic low back pain and heart failure, both of which are showing promising results and are nearing regulatory approval.
- 09/30/2024
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Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch
- NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George (“Investor”) for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD). The funding is available at Mesoblast's option and will enable the Company to seamlessly implement its go-to-market commercial strategy. Mesoblast anticipates a decision prior to or on the FDA's Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025.
- 09/29/2024
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Mesoblast Limited (MESO) Q4 2024 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q4 2024 Earnings Conference Call August 28, 2024 6:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Andrew Chaponnel - Interim Chief Financial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Operator Hello and welcome to the Mesoblast Financial Results for the Full Year ended June 30, 2024. An announcement and presentation have been lodged with the ASX and are available on the home and investor pages at www.
- 08/28/2024
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Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024
- NEW YORK, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: “During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products.
- 08/28/2024
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Mesoblast Financial Results and Corporate Update Webcast
- NEW YORK, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2024.
- 08/27/2024
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Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024
- Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD
- 07/30/2024
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FDA Accepts Mesoblast's Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
- If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD
- 07/23/2024
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Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain
- NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States.
- 07/21/2024
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Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
- NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD.
- 07/08/2024
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Mesoblast (MESO) Soars 208% YTD on Positive Regulatory Updates
- Mesoblast (MESO) skyrockets 208.2% year to date on encouraging progress with its pipeline candidates.
- 07/02/2024
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Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week
- NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week.
- 07/01/2024
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Mesoblast Corporate Presentation at Investor Conference
- NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference.
- 06/02/2024
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Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024
- FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart Failure FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart Failure
- 04/29/2024
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Feeling Bold? 3 Aggressive Plays to 10X Your Returns by 2025
- For bold investors, there are few opportunities as exciting as chasing 10x returns in the stock market. Make no mistake about it, the stock market offers up multiple opportunities to turn $1 into $10 quickly.
- 04/03/2024
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Mesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up
- Mesoblast (MESO) gains as the FDA states that the available phase III data for lead candidate, remestemcel-L, is sufficient to support a regulatory filing for pediatric SR-aGVHD indication.
- 03/27/2024
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United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
- NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
- 03/25/2024
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Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer
- NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer). Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million committed today on the same terms as the Entitlement Offer, primarily from Mesoblast's existing major shareholders.
- 03/13/2024
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United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD)
- NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast's allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21, 2024 for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.
- 03/10/2024
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Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023
- NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
- 02/28/2024
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Mesoblast Financial Results and Corporate Update Webcast
- NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the six months ended December 31, 2023.
- 02/26/2024
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United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease
- NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.
- 02/14/2024
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Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023
- NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: “It has been a very busy quarter in which we have made substantial operational progress across our three lead Phase 3 assets.
- 01/30/2024
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Top 4 Health Care Stocks That May Explode This Month - Mesoblast (NASDAQ:MESO), Humana (NYSE:HUM)
- The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.
- 01/26/2024
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Mesoblast (MESO) Up on Rare Pediatric Disease Tag for Heart Drug
- Mesoblast's (MESO) Revascor (rexlemestrocel-L) gets FDA's Rare Pediatric Disease designation for treating children with congenital heart disease. Shares rise in after-hours trading.
- 01/19/2024
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United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease
- REVASCOR Increases Size of Left Heart Chamber and Improves Surgical Outcomes in Children with Hypoplastic Left Heart Syndrome: Results Published in Journal of Thoracic and Cardiovascular Surgery Open NEW YORK, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) a Rare Pediatric Disease (RPD) Designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition. RPD Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children.
- 01/18/2024
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Mesoblast Limited (MESO) Loses -5.45% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
- Mesoblast Limited (MESO) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.
- 01/05/2024
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Mesoblast Has Major Hurdles
- The FDA has rejected Mesoblast's cell therapy candidate for pediatric acute graft versus host disease, causing the stock to decline. Mesoblast is an old company located in Australia, which may impact its resonance with the FDA. The FDA has a bias against cell and other human biologic therapies, making approval for Mesoblast's therapy challenging.
- 12/22/2023
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5 Stocks to Ride the Santa Claus Rally
- Mesoblast (MESO), Coinbase (COIN), Western Gas (WES), JAKKS Pacific (JAKK), and Brinker International (EAT) have the potential to outperform in the seven-day period.
- 12/21/2023
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Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease
- NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration (FDA) for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease hypoplastic left heart syndrome (HLHS). The filings were based on results from a blinded, randomized, controlled prospective trial of REVASCOR conducted at a single center in the US in 19 children with HLHS and accepted for publication in an upcoming issue of the peer reviewed The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open). 1
- 11/26/2023
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Mesoblast (MESO) Up on Deal With BMT CTN to Develop GVHD Drug
- Mesoblast (MESO) partners with Blood and Marrow Transplant Clinical Trials Network to develop a pivotal study on its lead candidate, Ryoncil, for acute graft versus host disease. The stock rises 11%.
- 11/23/2023
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Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD
- NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs, has entered into an agreement to develop a pivotal trial of Mesoblast's lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD). The BMT CTN is funded by the United States National Institutes of Health (NIH).
- 11/21/2023
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Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2023
- NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the first quarter ended September 30, 2023.
- 10/30/2023
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Mesoblast Limited (MESO) Q4 2023 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q4 2023 Results Conference Call August 30, 2023 6:30 PM ET Company Participants Dr. Silviu Itescu - Chief Executive Officer Dr. Eric Rose - Chief Medical Officer Andrew Chaponnel - Interim Chief Financial Officer Dr. Philip Krause - Board Member Conference Call Participants Louise Chen - Cantor Edward Tenthoff - Piper Sandler Sami Corwin - William Blair John Hester - Bell Potter Operator Hello and welcome to the Mesoblast Financial Results for the Period Ended June 30, 2023. An announcement and presentation have been lodged with the ASX and are also available on the home and investor pages@www.mesoblast.com.
- 08/30/2023
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Why Shares of Mesoblast Are Down Monday
- Several analysts have recently downgraded their positions on the pharmaceutical stock. Mesoblast focuses on therapies derived from the cells of the bone marrow from healthy donors.
- 08/07/2023
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Why Shares of Mesoblast Are Plunging Friday
- Mesoblast focuses on therapies to treat autoimmune disorders. The company's resubmission of Ryoncil was given a Complete Response Letter by the FDA.
- 08/04/2023
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FDA rejects Mesoblast's cell therapy for bone marrow transplant complications
- The U.S. Food and Drug Administration had rejected Mesoblast's , cell therapy for children under 12 years of age for treating a type of complication that occurs after a stem cell or bone marrow transplant, the company said on Thursday.
- 08/03/2023
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Best Momentum Stocks to Buy for July 26th
- IAS, MESO and PCOR made it to the Zacks Rank #1 (Strong Buy) momentum stocks list on July 26, 2023.
- 07/26/2023
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Are You Looking for a Top Momentum Pick? Why Mesoblast Limited (MESO) is a Great Choice
- Does Mesoblast Limited (MESO) have what it takes to be a top stock pick for momentum investors? Let's find out.
- 06/23/2023
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5 Biotech Stocks to Buy as Industry Prospects for 2H23 Look Good
- New drug approvals and pipeline progress are likely to help maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and a solid pipeline progress position PCVX, PTGX, LGND, MESO and PBYI well amid volatility.
- 06/13/2023
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Mesoblast Limited (MESO) Q3 2023 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q3 2023 Earnings Conference Call May 25, 2023 6:30 PM ET Company Participants Silviu Itescu – Chief Executive Officer Eric Rose – Chief Medical Officer Andrew Chaponnel – Interim Chief Financial Officer Conference Call Participants Edward Tenthoff – Piper Sandler Sami Corwin – William Blair John Hester – Bell Potter Operator Thank you all for standing by. Hello and welcome to the Mesoblast Financial Results for the period ended March 31, 2023.
- 05/25/2023
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Mesoblast's (MESO) GVHD Drug BLA Gets FDA Priority Tag, Stock Up
- Mesoblast (MESO) announces the FDA acceptance for review of the resubmitted biological license application for remestemcel-L for the treatment of children under 12 with steroid-refractory acute graft versus host disease. Stock gains on Wednesday, following the news.
- 03/09/2023
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Mesoblast Limited. (MESO) Q2 2023 Earnings Call Transcript
- Mesoblast Limited. (NASDAQ:MESO ) Q2 2023 Earnings Conference Call February 27, 2023 4:30 PM ET Company Participants Silviu Itescu – Chief Executive Officer Andrew Chaponnel – Chief Financial Officer Conference Call Participants Edward Tenthoff – Piper Sandler Swayampakula Ramakanth – HCW Silviu Itescu [Call Starts Abruptly] Thank you very much, operator.
- 03/02/2023
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Mesoblast Financial Results and Corporate Update Webcast
- NEW YORK, Feb. 26, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the second quarter ended December 31, 2022.
- 02/26/2023
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Mesoblast Limited (MESO) Upgraded to Buy: Here's What You Should Know
- Mesoblast Limited (MESO) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
- 12/15/2022
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Mesoblast Limited (MESO) Q1 2023 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q1 2023 Results Conference Call November 22, 2022 4:30 PM ET Company Participants Dr. Silviu Itescu - CEO and MD Andrew Chaponnel - Interim CFO Dr. Eric Rose - Chief Medical Officer Conference Call Participants Carvey Leung - Cantor Fitzgerald Edward Tenthoff - Piper Sandler Dr. Silviu Itescu Good morning, good afternoon to the operational highlights and financial results for the quarter ended September 30, 2022, as well as our upcoming Annual General Meeting. Apologies for the slight delay due to technical difficulties; beyond our control.
- 11/23/2022
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Mesoblast Financial Results and Corporate Update Webcast
- NEW YORK, Nov. 21, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the first quarter ended September 30, 2022.
- 11/21/2022
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Mesoblast Limited (MESO) Q4 2022 Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO ) Q4 2022 Earnings Conference Call August 30, 2022 6:30 PM ET Company Participants Silviu Itescu - CEO and MD Andrew Chaponnel - Interim CFO Eric Rose - Chief Medical Officer Conference Call Participants Michael Okunewitch - Maxim Group Edward Tenthoff - Piper Sandler Operator Thank you for standing by. And welcome to the Mesoblast Limited 2022 Full Year Financial Results Conference Call.
- 08/30/2022
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Mesoblast Corporate Update and Financial Results Webcast
- NEW YORK, Aug. 29, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the fourth quarter and full-year ended June 30, 2022.
- 08/29/2022
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Mesoblast Corporate Update and Financial Results Webcast
- NEW YORK, Feb. 24, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the second quarter ended December 31, 2021.
- 02/24/2022
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Mesoblast to Participate in Edison Group's Global Healthcare “Open House” Virtual Conference From January 25-27th, 2022
- NEW YORK, Jan. 24, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it is participating in Edison Group's Open House Event, scheduled to take place virtually this week. The three-day event, in association with London Stock Exchange, global law firm Taylor Wessing and OpenExchange, will take place between January 25-27th, focusing on 33 companies. Mesoblast will feature on Day one - Businesses within Pharmaceuticals & Drug Discovery.
- 01/24/2022
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Single Dose Of Mesoblast's Cell Therapy Shows Durable Reduction In Back Pain
- Mesoblast Limited (NASDAQ: MESO) announced 36-month follow-up results from the 400-subject Phase 3 trial of its allogeneic cell therapy rexlemestrocel-L in patients with chronic low back pain (CLBP) associated with degenerative disc disease (DDD). The data showed a durable reduction in back pain lasting at least three years from a single intra-discal injection of rexlemestrocel-L+hyaluronic acid (HA) carrier.
- 01/12/2022
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FDA's Office Agrees On 12-Month Reduction In Pain As Primary Endpoint For Mesoblast's Back Pain Study
- Mesoblast Limited (NASDAQ: MESO) received feedback from the FDA's Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients. The trial is assessing rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease refractory to available therapies, including opioids.
- 12/16/2021
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Down 35.1% in 4 Weeks, Here's Why You Should You Buy the Dip in Mesoblast Limited (MESO)
- The heavy selling pressure might have exhausted for Mesoblast Limited (MESO) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
- 12/15/2021
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Mesoblast's Heart Failure Candidate Shows Treatment Benefit In High-Risk Patients
- Mesoblast Limited (NASDAQ: MESO) announced new analyses from the landmark DREAM-HF Phase 3 trial of rexlemestrocel-L in HFrEF patients with diabetes and/or ischemia who are at high risk of cardiovascular mortality, heart attacks, or strokes. In recent guidance to Mesoblast, FDA confirmed that reduction in the incidence of cardiovascular mortality or irreversible morbidity is a clinically meaningful acceptable endpoint and encouraged Mesoblast to identify the highest-risk group with the greatest likelihood of beneficial response.
- 12/06/2021
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Mesoblast Limited (MESO) Forms 'Hammer Chart Pattern': Time for Bottom Fishing?
- After losing some value lately, a hammer chart pattern has been formed for Mesoblast Limited (MESO), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term.
- 12/01/2021
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Mesoblast Corporate Update and Financial Results Webcast
- NEW YORK, Nov. 23, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the first quarter ended September 30, 2021.
- 11/23/2021
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Mesoblast Announces Debt Refinancing And Expansion With Oaktree Capital
- Mesoblast Limited (NASDAQ: MESO) refinanced its existing senior debt facility with a new $90 million five-year facility provided by Oaktree Capital Management LP. Mesoblast drew the first tranche of $60 million on closing, with proceeds being used to repay the outstanding balance of the existing senior debt facility with Hercules Capital Inc.
- 11/22/2021
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Rexlemestrocel-L Phase 3 Trial Results in Chronic Heart Failure Selected as Late Breaking Presentation at American Heart Association Annual Meeting
- NEW YORK, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that results from the randomized, controlled Phase 3 trial of rexlemestrocel-L in 565 patients with New York Heart Association (NYHA) class II and class III chronic heart failure (CHF) with low ejection fraction (HFrEF) have been selected through peer review as a late breaking presentation at the American Heart Association (AHA) annual meeting occurring November 13th- 15th. The featured session is titled ‘Building on the Foundations of Treatment: Advances in Heart Failure Therapy'.
- 10/06/2021
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Why Mesoblast Stock Is Plunging After Q4 Earnings Report?
- Mesoblast Limited (NASDAQ: MESO) shares dived on Tuesday as the FDA raised more questions around its flagship drug candidate, and its annual loss widened. What Happened: In the June quarter, Mesoblast met FDA on potential regulatory approval of remestemcel-L, used to treat acute graft versus host disease (SR-aGVHD) in children and treat acute respiratory distress syndrome (ARDS) in adults with COVID-19.
- 08/31/2021
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Operational Highlights and Financial Results for the Year Ended June 30, 2021
- NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the fourth quarter and full-year ended June 30, 2021 (FY2021).
- 08/30/2021
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Appendix 4C Quarterly Activity Report
- Mesoblast Operational and Financial Highlights for Quarter Ended June 30, 2021 Mesoblast Operational and Financial Highlights for Quarter Ended June 30, 2021
- 07/29/2021
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Mesoblast Shares 90-Day Survival Outcomes After Remestemcel-L From COVID-19 ARDS Trial
- Mesoblast Limited (NASDAQ: MESO) has announced the presentation of 90-day survival outcomes from the remestemcel-L trial in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS). The data were presented at the International Society for Cell & Gene Therapy Scientific Signatures Series on Cell and Gene Therapies in Lung Diseases and Critical Illnesses.
- 07/19/2021
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Ninety Day Survival Outcomes in COVID-19 ARDS Trial of Remestemcel-L Presented at ISCT Meeting on Advances in Cell & Gene Therapies for Lung Diseases
- NEW YORK, July 18, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, presented 90-day survival outcomes from the 222-patient randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at an invited presentation on July 17 to the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series on Cell and Gene Therapies in Lung Diseases and Critical Illnesses. The results showed that two doses of remestemcel-L at days 3-5 conferred durable survival benefit through at least 90 days in the pre-specified subgroup of patients under age 65.
- 07/18/2021
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Mesoblast Presents Respiratory Function Results of COVID-19 ARDS Trial at Pulmonary Disease Conference
- NEW YORK, July 15, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today presented clinical outcomes from the randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS). Results of respiratory function were highlighted at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, on July 15. The invited presentation was given by Mesoblast Chief Executive Officer, Dr Silviu Itescu, and materials have been lodged with the ASX.
- 07/15/2021
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Mesoblast Provides Update on Program for Chronic Low Back Pain Due to Degenerative Disc Disease
- NEW YORK, June 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the strategy for bringing rexlemestrocel-L to patients in the United States (US) with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids. Excessive use of opioids in this patient population continues to be a major focus for US healthcare policymakers, regulatory authorities, patients and physicians, with more than 50% of US opioid prescriptions being for the treatment of CLBP.1,6,7
- 06/30/2021
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Operational Highlights and Financial Results for the Period Ended March 31, 2021
- NEW YORK, June 02, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the period ended March 31, 2021.
- 06/02/2021
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Mesoblast Corporate Update and Financial Results Webcast
- NEW YORK, June 02, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to discuss operational highlights and financial results for the period ending March 31, 2021.
- 06/02/2021
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Strength Seen in Mesoblast Limited (MESO): Can Its 6.1% Jump Turn into More Strength?
- Mesoblast Limited (MESO) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
- 05/03/2021
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Why Mesoblast Limited Stock Is Jumping Today
- The company announced positive results from a clinical trial.
- 04/30/2021
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MESO Stock: From $7.22 To $8.99 Explanation
- The stock price of Mesoblast Limited (Nasdaq: MESO) increased from $7.22 to a day high of $8.99 during intraday trading this morning. This is why it happened.
- 04/30/2021
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Mesoblast Shares Rise As Remestemcel-L Cuts Mortality In Patients Below 65 Years With COVID-19 Related Respiratory Distress
- Mesoblast Limited (NASDAQ: MESO) has announced 60-day results from the randomized controlled trial of remestemcel-L in COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS), which had been halted after the third interim analysis, as previously announced. The trial enrolled 222 mechanically ventilated COVID-19 patients.
- 04/30/2021
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Appendix 4C Quarterly Activity Report
- Mesoblast Operational and Financial Highlights for Quarter Ended March 31, 2021 Mesoblast Operational and Financial Highlights for Quarter Ended March 31, 2021
- 04/29/2021
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Mesoblast Corporate Update
- NEW YORK, April 29, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update.
- 04/29/2021
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Mesoblast Operational Highlights and Upcoming Milestones
- NEW YORK, March 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an overview of the Company's recent operational highlights, as well as upcoming milestones.
- 03/30/2021
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BioCardia Is Super Cheap With Multiple Shots On Goal
- BioCardia Is Super Cheap With Multiple Shots On Goal
- 03/25/2021
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Mesoblast Closes US$110/A$138 Million Financing Led by US Strategic Investor Group
- NEW YORK, March 08, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today the successful completion and settlement of its US$110 million private placement led by a strategic US investor group, that was announced on Tuesday, March 2, 2021.
- 03/08/2021
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Positive Outcomes of First Children Treated With Remestemcel-L for Multisystem Inflammatory Syndrome (MIS-C) and Heart Failure Post-COVID-19 Published in Pediatrics
- NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Pediatrics (Journal of the American Academy of Pediatrics) has published a paper on the first two children treated with Mesoblast's mesenchymal stromal cell (MSC) product candidate remestemcel-L for life-threatening multisystem inflammatory syndrome (MIS-C) associated with COVID-19.
- 02/17/2021
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Why Mesoblast Limited Is Rising Today
- One of its pipeline candidates achieved great results in a late-stage clinical study.
- 02/11/2021
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Mesoblast Spikes On Positive Cell Therapy Data in Back Pain Study
- Positive results from Mesoblast Limited's (NASDAQ: MESO) chronic back pain treatment trial have boosted investor confidence sending the company's shares higher in the premarket after an announcement showing its stem cell treatment for chronic lower back pain is “safe, durable, and effective.” Phase 3 trial results have shown that a single injection of rexlemestrocel-L in 404 enrolled patients suffering from lower back pain due to degenerative disc disease results in at least two years of pain reduction.
- 02/11/2021
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Mesoblast Phase 3 Trial Shows That a Single Injection of Rexlemestrocel-L + Hyaluronic Acid Carrier Results in at Least Two Years of Pain Reduction With Opioid Sparing Activity in Patients With Chronic Low Back Pain Due to Degenerative Disc Disease
- NEW YORK, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced results from the Phase 3 randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments. The results indicate that a single injection of rexlemestrocel-L may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred.
- 02/10/2021
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Mesoblast Corporate Update
- NEW YORK, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update.
- 02/10/2021
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Longeveron Seeks $25 Million IPO For Anti-Aging Efforts
- Longeveron Seeks $25 Million IPO For Anti-Aging Efforts
- 02/05/2021
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Mesoblast Operational and Financial Highlights for Quarter Ended December 31, 2020
- NEW YORK, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its pipeline of late-stage product candidates, and an activity report for the second quarter ended December 31, 2020.
- 01/28/2021
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Is the Options Market Predicting a Spike in Mesoblast (MESO) Stock?
- Investors need to pay close attention to Mesoblast (MESO) stock based on the movements in the options market lately.
- 01/12/2021
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Mesoblast Presents Heart Failure Phase 3 Trial Results at Investor Healthcare Conference
- NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that its Chief Executive Officer, Dr Silviu Itescu, today presented additional data from the landmark DREAM-HF Phase 3 trial in patients with chronic heart failure. The presentation materials have been lodged with the ASX, and Mesoblast's presentation at the H.C. Wainwright Virtual BioConnect 2021 Conference can be accessed at https://journey.ct.events/view/f353f7fd-772e-43aa-aab0-e959da38254d . An archived webcast of the conference presentation will be available for 90 days on the Company's website at www.mesoblast.com .
- 01/11/2021
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Why Mesoblast Stock Skyrocketed Today
- The company announced positive results from a clinical trial.
- 01/11/2021
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Single Dose of Rexlemestrocel-L Provides Substantial and Durable Reduction in Heart Attacks, Strokes and Cardiac Death in Patients With Chronic Heart Failure
- NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced additional results from the landmark DREAM-HF randomized controlled Phase 3 trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR®) or control sham. A single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. Since existing therapies have only minimal or no benefit on these endpoints, these notable outcomes may signal a breakthrough in addressing the principal unmet needs in patients with chronic heart failure. The results of this trial identify New York Heart Association (NYHA) class II HFrEF patients as the optimal target population for greatest rexlemestrocel-L treatment effect, and therefore a focus for registration and commercialization of rexlemestrocel-L in the largest market in heart failure.
- 01/10/2021
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Why Mesoblast Stock Plummeted on Friday
- Investors are losing confidence because the company disappointed in a late-stage trial for the second time this week.
- 12/18/2020
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Mesoblast Webcast – Update on COVID-19 ARDS Trial
- NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide an update on the randomized controlled trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection.
- 12/17/2020
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Mesoblast Update on COVID-19 ARDS Trial
- NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update on the randomized controlled trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial's first 180 patients. The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care in a trial of 300 patients. This projected mortality reduction was based on pilot data observed during the initial stages of the pandemic when control mortality rates were exceedingly high and prior to new evolving treatment regimens that have reduced disease mortality in ventilated patients. The DSMB reported that there were no safety concerns and noted that the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The DSMB recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.
- 12/17/2020
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Why Mesoblast Stock Is Tanking Today
- The company reported disappointing results from a late-stage clinical study.
- 12/15/2020
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Mesoblast Provides Topline Results From Phase 3 Trial of Rexlemestrocel-L for Advanced Chronic Heart Failure
- NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced top-line results from the landmark DREAM-HF Phase 3 randomized controlled trial of its allogeneic cell therapy rexlemestrocel-L (REVASCOR®) in 537 patients with advanced chronic heart failure1.
- 12/14/2020
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Mesoblast Corporate Update
- NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update.
- 12/14/2020
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MESO ALERT: The Klein Law Firm Announces a Lead Plaintiff Deadline of December 7, 2020 in the Class Action Filed on Behalf of Mesoblast Limited Limited Shareholders
- New York, New York--(Newsfile Corp. - December 7, 2020) - The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) alleging that the Company violated federal securities laws.Class Period: April 16, 2019 and October 1, 2020Lead Plaintiff Deadline: December 7, 2020Learn more about your recoverable losses in MESO:
- 12/07/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - December 7, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 12/07/2020
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DEADLINE TODAY: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Mesoblast Limited and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
- Los Angeles, California--(Newsfile Corp. - December 7, 2020) - The Schall Law Firm, a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Mesoblast Limited ("Mesoblast" or "the Company") (NASDAQ: MESO) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between April 16, 2019 and October 1, 2020, inclusive...
- 12/07/2020
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MESO Final Deadline Today: Rosen, Leading Trial Attorneys, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action - MESO
- New York, New York--(Newsfile Corp. - December 7, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action, go...
- 12/07/2020
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Remestemcel-L Reduces Inflammatory Biomarkers Predictive of High Mortality in Acute Graft Versus Host Disease
- Biomarker Study Results Presented at the 62nd American Society of Hematology Annual Meeting Biomarker Study Results Presented at the 62nd American Society of Hematology Annual Meeting
- 12/07/2020
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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Mesoblast Limited of Class Action Law Suit and Upcoming Deadline - MESO
- NEW YORK, Dec. 5, 2020 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Mesoblast Limited ("Mesoblast" or the "Company") (NASDAQ: MESO) and certain of its officers. The class action, filed in United States District Court for the Southern District...
- 12/05/2020
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MESO FINAL DEADLINE MONDAY: ROSEN, A HIGHLY RECOGNIZED LAW FIRM, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action – MESO
- NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the “Class Period”), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws. To join the Mesoblast class action, go to http://www.rosenlegal.com/cases-register-192
- 12/05/2020
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DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors That a Class Action Lawsuit Has Been Filed Against Mesoblast Limited and Encourages Investors to Contact the Firm
- NEW YORK--(BUSINESS WIRE)-- #Classaction--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of investors that purchased Mesoblast Limited (NASDAQ: MESO) securities between April 16, 2019 and October 1, 2020 (the “Class Period”). Investors have until December 7, 2020 to apply to the Court to be appointed as lead plaintiff in the law
- 12/04/2020
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MESO Deadline Alert: Bronstein, Gewirtz & Grossman, LLC Reminds Mesoblast Limited Investors of Class Action and Lead Plaintiff Deadline: December 7, 2020
- NEW YORK--(BUSINESS WIRE)--Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Mesoblast Limited ("Mesoblast” or "the Company") (NASDAQ: MESO) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Mesoblast securities between April 16, 2019 and October 1, 2020, both dates inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the firm's site: www.bgandg.com/meso. Th
- 12/04/2020
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MESO FINAL DEADLINE: ROSEN, A LEADING LAW FIRM, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action – MESO
- NEW YORK, Dec. 03, 2020 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the “Class Period”), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.
- 12/03/2020
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MONDAY DEADLINE NOTICE: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Mesoblast Limited and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
- Los Angeles, California--(Newsfile Corp. - December 3, 2020) - The Schall Law Firm, a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Mesoblast Limited ("Mesoblast" or "the Company") (NASDAQ: MESO) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between April 16, 2019 and October 1, 2020, inclusive...
- 12/03/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - December 2, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get...
- 12/02/2020
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MESO Deadline Alert: Bronstein, Gewirtz & Grossman, LLC Reminds Mesoblast Limited Investors of Class Action and Lead Plaintiff Deadline: December 7, 2020
- New York, New York--(Newsfile Corp. - December 2, 2020) - Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Mesoblast Limited ("Mesoblast" or "the Company") (NASDAQ: MESO) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Mesoblast securities between April 16, 2019 and October 1, 2020, both dates inclusive (the "Class Period"). Such investors are encouraged to join this case by visiting the...
- 12/02/2020
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MONDAY DEADLINE REMINDER: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Mesoblast Limited and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
- Los Angeles, California--(Newsfile Corp. - December 2, 2020) - The Schall Law Firm, a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Mesoblast Limited ("Mesoblast" or "the Company") (NASDAQ: MESO) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between April 16, 2019 and October 1, 2020, inclusive...
- 12/02/2020
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FDA Grants Fast Track Designation for Remestemcel-L in the Treatment of Acute Respiratory Distress Syndrome Due to COVID-19
- NEW YORK, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection. Fast Track designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-threatening disease.1 ARDS is the primary cause of death in patients with COVID-19.
- 12/02/2020
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Rosen, Top Ranked Investor Counsel, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm - MESO
- New York, New York--(Newsfile Corp. - December 1, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action, go...
- 12/01/2020
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MONDAY DEADLINE ALERT: The Schall Law Firm Announces the Filing of a Class Action Lawsuit Against Mesoblast Limited and Encourages Investors with Losses in Excess of $100,000 to Contact the Firm
- Los Angeles, California--(Newsfile Corp. - December 1, 2020) - The Schall Law Firm, a national shareholder rights litigation firm, announces the filing of a class action lawsuit against Mesoblast Limited ("Mesoblast" or "the Company") (NASDAQ: MESO) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between April 16, 2019 and October 1, 2020, inclusive...
- 12/01/2020
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ROSEN, RESPECTED INVESTOR COUNSEL, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm - MESO
- NEW YORK, Nov. 28, 2020 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff...
- 11/28/2020
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Where Do Hedge Funds Stand On Mesoblast Limited (MESO)?
- We at Insider Monkey have gone over 817 13F filings that hedge funds and prominent investors are required to file by the SEC The 13F filings show the funds' and investors' portfolio positions as of September 30th. In this article, we look at what those funds think of Mesoblast Limited (NASDAQ:MESO) based on that data.
- 11/27/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - November 24, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 11/24/2020
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MESO ALERT: The Klein Law Firm Announces a Lead Plaintiff Deadline of December 7, 2020 in the Class Action Filed on Behalf of Mesoblast Limited Limited Shareholders
- New York, New York--(Newsfile Corp. - November 23, 2020) - The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) alleging that the Company violated federal securities laws.Class Period: April 16, 2019 and October 1, 2020Lead Plaintiff Deadline: December 7, 2020Learn more about your recoverable losses in MESO:
- 11/23/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - November 23, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get...
- 11/23/2020
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ROSEN, A TOP RANKED FIRM, Reminds Mesoblast Limited Investors of Important December 7 Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm - MESO
- New York, New York--(Newsfile Corp. - November 20, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action, go...
- 11/20/2020
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Why Mesoblast Stock Is Blasting Off Today
- Investors are excited about the biotech's new collaboration with Novartis.
- 11/20/2020
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Operational and Financial Results for the Period Ended September 30, 2020
- NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational and financial results for the first quarter ended September 30, 2020 (FY2021).
- 11/19/2020
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Mesoblast Enters Global Collaboration for Development, Manufacture and Commercialization of Remestemcel-L
- Initial Focus on Acute Respiratory Distress Syndrome, including COVID-19 Initial Focus on Acute Respiratory Distress Syndrome, including COVID-19
- 11/19/2020
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Mesoblast Corporate Update and Financial Results Webcast
- NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast today to provide a corporate update, and report financial and operational highlights for the first quarter ended September 30, 2020 (FY2021).
- 11/19/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - November 18, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 11/18/2020
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Rosen, A Trusted and Leading Law Firm, Reminds Mesoblast Limited Investors of Important Deadline in Securities Class Action; Encourages Investors with Large Losses to Contact Firm - MESO
- New York, New York--(Newsfile Corp. - November 17, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action, go...
- 11/17/2020
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ROSEN, GLOBAL INVESTOR COUNSEL, Reminds Mesoblast Limited Investors of Important Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm - MESO
- NEW YORK, Nov. 14, 2020 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff...
- 11/14/2020
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MESO ALERT: The Klein Law Firm Announces a Lead Plaintiff Deadline of December 7, 2020 in the Class Action Filed on Behalf of Mesoblast Limited Limited Shareholders
- New York, New York--(Newsfile Corp. - November 11, 2020) - The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) alleging that the Company violated federal securities laws.Class Period: April 16, 2019 and October 1, 2020Lead Plaintiff Deadline: December 7, 2020Learn more about your recoverable losses in MESO:
- 11/11/2020
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Rosen, National Trial Counsel, Reminds Mesoblast Limited Investors of Important Deadline in Securities Class Action - MESO
- New York, New York--(Newsfile Corp. - November 11, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action, go...
- 11/11/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - November 11, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 11/11/2020
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Second Interim Analysis of Clinical Outcomes After 135 Patients Results in Recommendation to Continue Remestemcel-L Phase 3 Trial in COVID-19 ARDS
- NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today announced that the randomized controlled Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection had received a recommendation to continue from the independent Data Safety Monitoring Board (DSMB) following completion of the trial's second interim analysis. The analysis was performed on the trial's first 135 patients, 45% of the total target of up to 300 randomized patients, with the DSMB recommending continuation after reviewing the trial's primary endpoint, all-cause mortality within 30 days of randomization and all safety data. The key secondary endpoint is days alive off mechanical ventilatory support within 60 days of randomization.
- 11/11/2020
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Rosen, Top Ranked Investor Counsel, Reminds Mesoblast Limited Investors of Important Deadline in Securities Class Action - MESO
- New York, New York--(Newsfile Corp. - November 6, 2020) - Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Mesoblast investors under the federal securities laws.To join the Mesoblast class action,...
- 11/06/2020
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Pomerantz Law Firm Announces the Filing of a Class Action against and Mesoblast Limited Certain Officers - MESO
- NEW YORK, Oct. 30, 2020 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Mesoblast Limited ("Mesoblast" or the "Company") (NASDAQ: MESO) and certain of its officers. The class action, filed in United States District Court for the Southern District...
- 10/30/2020
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The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Mesoblast Limited (MESO)
- LOS ANGELES, Oct. 30, 2020 /PRNewswire/ -- The Law Offices of Frank R. Cruz reminds investors of the upcoming December 7, 2020 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased Mesoblast Limited ("Mesoblast" or the "Company") (NASDAQ:...
- 10/30/2020
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Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHD
- Quarterly Activity Report Quarterly Activity Report
- 10/29/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - October 28, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 10/28/2020
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ROSEN, A LEADING LAW FIRM, Reminds Mesoblast Limited Investors of Important Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm - MESO
- NEW YORK, Oct. 28, 2020 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Mesoblast Limited (NASDAQ: MESO) between April 16, 2019 and October 1, 2020, inclusive (the "Class Period"), of the important December 7, 2020 lead plaintiff...
- 10/28/2020
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SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Shareholders of Mesoblast Limited of a Class Action Lawsuit and a Lead Plaintiff Deadline of December 7, 2020 - MESO
- New York, New York--(Newsfile Corp. - October 26, 2020) - The following statement is being issued by Levi & Korsinsky, LLP:To: All persons or entities who purchased or otherwise acquired securities of Mesoblast Limited ("Mesoblast") (NASDAQ: MESO) between April 16, 2019 and October 1, 2020. You are hereby notified that a securities class action lawsuit has been commenced in the the United States District Court for the Southern District of New York. To get more...
- 10/26/2020
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Calithera Terminating Partnership, And Other News: The Good, Bad And Ugly Of Biopharma
- Calithera signals terminating partnership with Incyte. Lexicon reports dosing in Phase 2 clinical study for LX9211.
- 09/09/2020
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Mesoblast Before The PDUFA
- Mesoblast's stem cell therapy candidate has had an outstanding advisory committee meeting where it was voted 9-1. Approval at PDUFA next month is a given.
- 08/31/2020
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Mesoblast Limited (MESO) CEO Silviu Itescu on Q4 2020 Results - Earnings Call Transcript
- Mesoblast Limited (NASDAQ:MESO) Q4 2020 Earnings Conference Call August 26, 2020 6:00 P.M. ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Josh Muntner - Chief Financial Officer Fred Grossman - Chief Medical Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Jeffrey Cohen - Ladenburg Thalmann & Co.
- 08/27/2020
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Mesoblast Limited 2020 Q4 - Results - Earnings Call Presentation
- The following slide deck was published by Mesoblast Limited in conjunction with their 2020 Q4 earnings call.
- 08/27/2020
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Mesoblast Limited Investors: Company Investigated by the Portnoy Law Firm
- Investors can contact the law firm at no cost to learn more about recovering their lossesLOS ANGELES, Aug. 19, 2020 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Mesoblast Limited ("Mesoblast" or the "Company") (Nasdaq: MESO) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors. The investigation focuses on violations of the securities laws. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case via www.portnoylaw.com. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.The investigation focuses on whether the Company issued misleading and/or false statements and/or failed to disclose information pertinent to investors. On August 11, 2020, the FDA released briefing materials for the August 13, 2020, meeting of the Oncologic Drugs Advisory Committee. The meeting was to discuss the marketing application of Mesoblast for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. According to the FDA briefing documents, it was "unclear" if these study results are "relevant" to the proposed indication. On August 11, shares of Mesoblast fell by nearly 35% based on this news.Please visit our website to review more information and submit your transaction information.The Portnoy Law Firm represents investors in pursuing claims arising from corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.Lesley F. Portnoy, Esq. Admitted CA and NY Bar lesley@portnoylaw.com 310-692-8883 www.portnoylaw.comAttorney Advertising
- 08/19/2020
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EQUITY ALERT: ROSEN, A TRUSTED AND TOP RANKED FIRM, Announces Investigation of Securities Claims Against Mesoblast Limited; Encourages Investors with Losses in Excess of $100K to Contact the Firm – MESO
- NEW YORK, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) resulting from allegations that Mesoblast may have issued materially misleading business information to the investing public.On August 11, 2020, the U.S. Food and Drug Administration ("FDA") released briefing materials for the August 13, 2020 meeting of the FDA's Oncologic Drugs Advisory Committee, at which the FDA will review and discuss Mesoblast's marketing application for Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The FDA briefing documents stated that it is "unclear" whether the study results supporting Mesoblast's application are "relevant" to the proposed indication for use.On this news, Mesoblast's stock price fell $6.09 per share, or 34.96%, to close at $11.33 per share on August 11, 2020.Rosen Law Firm is preparing a securities lawsuit on behalf of Mesoblast shareholders. If you purchased securities of Mesoblast please visit the firm’s website at http://www.rosenlegal.com/cases-register-1923.html to join the securities action. You may also contact Phillip Kim of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or cases@rosenlegal.com.Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.Attorney Advertising. Prior results do not guarantee a similar outcome.Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 Toll Free: (866) 767-3653 Fax: (212) 202-3827 lrosen@rosenlegal.com pkim@rosenlegal.com cases@rosenlegal.com www.rosenlegal.com
- 08/18/2020
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INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited and Encourages Investors with Losses of $100,000 to Contact the Firm
- INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited
- 08/18/2020
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Bronstein, Gewirtz & Grossman, LLC Notifies Shareholders of Mesoblast Limited (MESO) Investigation
- NEW YORK, NY / ACCESSWIRE / August 17, 2020 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Mesoblast Limited (‘Mesoblast" or the "Company") (NASDAQ:MESO).
- 08/17/2020
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INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited and Encourages Investors with Losses of $100,000 to Contact the Firm
- INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Mesoblast Limited
- 08/17/2020
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MESO EQUITY ALERT: Rosen Law Firm Announces Investigation of Securities Claims Against Mesoblast Limited – MESO
- Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Mesoblast Limited (NASDAQ: MESO) resulting from allegations that Mesoblast may have issued materially misleading business information to the investing public.
- 08/16/2020
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Mesoblast Gets Favorable Votes From FDA Committee for Ryoncil
- Mesoblast (MESO) gets ODAC's vote in the ratio of 9:1 for GVHD drug.
- 08/14/2020
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5 Stock Gainers for Friday: Dillard's, Intrepid Potash, Suzano SA
- Intrepid Potash, Suzano SA, Mesoblast, Farfetched and Dillard's are among Friday's top gainers.
- 08/14/2020
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Why Mesoblast's Stock is Trading Higher Today
- Mesoblast (NASDAQ: MESO) shares are trading higher after the company announced the Oncologic Drugs Advisory Committee of the FDA voted in favor of its RYONCIL for efficacy in children with steroid-refractory acute graft versus host disease.RYONCIL has been accepted for Priority Review by the FDA with an action date of Sept. 30, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.Mesoblast is a small-cap biotech company with listings on both the ASX and the Nasdaq. The company has acquired the rights to develop and commercialize certain regenerative medicine technologies aimed at innovative ways of treating inflammatory diseases. Mesoblast was trading 44.24% higher at $17.03 at time of publication. The stock has a 52-week high of $20.57 and a 52-week low of $3.12.See more from Benzinga * Why Applied Materials Stock Is Trading Higher Today * Why TFF Pharmaceuticals Is Trading Higher Today * 13 Stocks Moving In Thursday's After-Hours Session(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- 08/14/2020
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TG Therapeutics Umbralisib Development, And Other News: The Good, Bad And Ugly Of Biopharma
- TG Therapeutics reports development for Umbralisib. Mesoblast gets FDA nod for Ryoncil.
- 08/14/2020
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U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil™) for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease
- NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL™) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast Chief Medical Officer Dr Fred Grossman said: “Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.”The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.Pediatric transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: “This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.”Conference Call An audio webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200813/NaN5f3237e85300840019de909dThe archived webcast is also available on the Investor page of the Company’s website www.mesoblast.comAbout Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.About RYONCILTM Mesoblast’s lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.1\. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85. 2\. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953. 3\. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @MesoblastForward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any decision that the FDA may make based upon the recommendation of the ODAC in relation to the efficacy of remestemcel-L), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.Release authorized by the Chief Executive.For further information, please contact: Media Julie Meldrum T: +61 3 9639 6036 E:julie.meldrum@mesoblast.com Kristen Bothwell T: +1 917 613 5434 E:kbothwell@rubenstein.com Investors Schond Greenway T: +212 880 2060 E: schond.greenway@mesoblast.com Paul Hughes T: +61 3 9639 6036 E: paul.hughes@mesoblast.com
- 08/14/2020
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SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Mesoblast Limited - MESO
- Pomerantz LLP is investigating claims on behalf of investors of Mesoblast Limited ("Mesoblast" or the "Company") (NASDAQ: MESO). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.
- 08/14/2020
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Mesoblast Tanks 35% Ahead Of FDA Meeting; Analyst Sees 85% Stock Upside
- Australian biotech Mesoblast sank 35% on Tuesday ahead of this week’s US Federal Drug Administration (FDA) committee meeting, which will assess the efficacy of its flagship stem cell therapy candidate.The stock dived to $11.33 at the close on Tuesday and is currently down 1.9% in pre-market trading. Mesoblast (MESO) disclosed that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet on Thursday to review data supporting its Biologics License Application (BLA) for the approval of its stem cell candidate remestemcel-L for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children, a severe immune response which can occur after a bone marrow transplant.There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer. The stem cell therapy candidate is also currently being studied in the US as a treatment for COVID-19 patients suffering from acute respiratory distress.The ODAC will vote in the afternoon session on Aug. 13 whether the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD. The session will discuss the Phase 3 trial results and supporting clinical data included in the BLA. It will also discuss issues related to the characterization and critical quality attributes of remestemcel-L.The ODAC is an independent panel of experts that provides advice and recommendations based on potential issues highlighted by the FDA during their review of the efficacy and safety of marketed and investigational products for use in the treatment of cancer. One of the issues raised by the FDA is whether more evidence is needed to demonstrate the treatment delivers benefits to human patients.Although the FDA will consider the recommendation of the advisory committee, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding. The FDA is scheduled to make a decision on the application on Sept. 30.H.C. Wainwright analyst Swayampakula Ramakanth believes that the treatment is likely to be approved before the Sept. 30 deadline “due to a strong combination of safety and efficacy” adding that “the main issues raised by the FDA are addressable”.“Taking into consideration the FDA’s analyses, we believe the benefit of Ryoncil for pediatric patients with SR-aGVHD continue to significantly outweigh its risks,” Ramakanth wrote in a note to investors. “At the same time, we note that the agency could request the company to complete a post-marketing study in order to provide additional data.”Nonetheless, Ramakanth reiterated a Buy on Mesoblast along with a $21 price target, which implies potential upside of 85% from current levels. (See Mesoblast stock analysis on TipRanks)Overall MESO scores 5 unanimous Buy ratings from analysts which add up to a Strong Buy consensus. Despite the stock’s 54% rally this year, the $18.05 average price target still indicates 59% upside potential.Related News: Pfizer Inks Deal To Manufacture Gilead’s Covid-19 Remdesivir Treatment Inovio To Start P2/3 Study Of Covid-19 Candidate In Sept.; Shares Drop 8% Novavax Rises 5% On Earnings; $2B Covid-19 Vaccine Funding More recent articles from Smarter Analyst: * Eli Lilly, Innovent’s TYVYT Expanded Use Application Accepted In China * ASOS: ‘100% Profit Beat’ Cheers RBC Capital On Trading Update * Truist Securities Ramps Up Wayfair’s PT On Improving Profitability * Equinix Enters India With $161M GPX Global Deal; RBC Bullish
- 08/12/2020
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Mesoblast Plunges as FDA Questions Cell-Therapy Manufacturing
- The Australian stem-cell company will face some pointed questions from regulators about how it manufactures stem cells.
- 08/11/2020
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Update on Scheduled FDA Advisory Committee Meeting
- NEW YORK, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update on the scheduled meeting of the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) which will review data supporting the Company’s Biologics License Application (BLA) for approval of RYONCIL™ (remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children. There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer. The meeting is scheduled to take place on August 13, 2020 from 8am to 5pm ET. The ODAC will vote in the afternoon session on whether the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD. This session will discuss the Phase 3 trial results and supporting clinical data included in the BLA. The morning session will be non-voting and will discuss issues related to the characterization and critical quality attributes of remestemcel-L.Mesoblast has extensively prepared for this meeting and has provided a publicly available briefing book. Briefing materials and webcast information can be found on the FDA website at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/august-13-2020-meeting-oncologic-drugs-advisory-committee-meeting-announcement-08132020-08132020event-materialsThe ODAC is an independent panel of experts that provides advice and appropriate recommendations to the FDA based on potential issues highlighted by the FDA during their review of the efficacy and safety of marketed and investigational products for use in the treatment of cancer. Although the FDA will consider the recommendation of the advisory committee, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.RYONCIL is under Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA).About RYONCILTM (remestemcel-L) Mesoblast’s lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @MesoblastForward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.Release authorized by the Chief Executive.For further information, please contact: Media Julie Meldrum T: +61 3 9639 6036 E:julie.meldrum@mesoblast.com Kristen Bothwell T: +1 917 613 5434 E:kbothwell@rubenstein.com Investors Schond Greenway T: +212 880 2060 E: schond.greenway@mesoblast.com Paul Hughes T: +61 3 9639 6036 E: paul.hughes@mesoblast.com
- 08/11/2020
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Kamada: Under-The-Radar COVID-19 Therapy Play With Downside Protection And Margin Of Safety
- US and global pharma companies that are working on credible COVID-19 treatments are up massively YTD, often more than 100% and far surpassing performance of general pharma indices.
- 07/22/2020
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FDA Advisory Committee Sets Review Date for Mesoblast’s remestemcel-L in Pediatric Steroid-Refractory Acute Graft Versus Host Disease
- NEW YORK, July 21, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug.
- 07/21/2020
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Mesoblast Solving Unmet Medical Needs Including Severe ARDS Caused By COVID-19
- MESO has been approved to sell remestemcel-l (labeled TEMCELL by partner JCR Pharmaceuticals) for acute Graft vs Host disease (aGVHD) in Japan for several years.
- 07/17/2020
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Is Mesoblast Limited's (ASX:MSB) Shareholder Ownership Skewed Towards Insiders?
- A look at the shareholders of Mesoblast Limited (ASX:MSB) can tell us which group is most powerful. Generally...
- 07/17/2020
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Mesoblast expands compassionate use COVID-19 program
- Mesoblast has developed a cellular therapy that may significantly reduce deaths among the most severely sick COVID-19 patients. CEO Dr. Fred Grossman joins Yahoo Finance's On the Move to discuss what this development could mean in the fight against the virus.
- 07/10/2020
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Here's Why Mesoblast Stock Rose Over 18% Today
- The Australian biopharma earned an important clearance to treat COVID-19 patients in the United States, which could be a sign of things to come.
- 07/06/2020
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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19
- NEW YORK, July 06, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for.
- 07/06/2020
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Don't Forget Cytodyn's Other Prospects
- Coronavirus results to be reported in July. Anecdotal results are excellent. HIV results are excellent. BLA has been applied for. 12 ladies with triple negati
- 06/25/2020
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Remestemcel-L Improves Respiratory and Functional Outcomes in Patients With Inflammatory Lung Disease
- NEW YORK, June 01, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that.
- 06/01/2020
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Is Mesoblast Limited (MESO) A Good Stock To Buy?
- The financial regulations require hedge funds and wealthy investors that exceeded the $100 million equity holdings threshold to file a report that shows their positions at the end of every quarter. Even though it isn't the intention, these filings to a certain extent level the playing field for ordinary investors. The latest round of 13F […]
- 05/31/2020
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Mesoblast Limited (MESO) Q3 2020 Earnings Call Transcript
- Hello, and welcome to the financial results for the period ended March 31, 2020, and corporate update for Mesoblast. Before we begin, let me remind you that in today's conference call the company will be making forward-looking statements that represent the company's intentions, expectations or beliefs concerning future events. In addition, any forward-looking statements represent the company's views only as of the date of this webcast and should not be relied upon as representing the company's views of any subsequent date.
- 05/28/2020
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Mesoblast Reports Strong Financial Position and Substantial Operational Progress For the Period Ended March 31, 2020
- NEW YORK, May 27, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial,.
- 05/27/2020
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Mesoblast to Host Analyst Call on Financial Results for Period Ended March 31, 2020
- NEW YORK, May 26, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, will host an analyst call to discuss the.
- 05/26/2020
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Clinical Outcomes Using RYONCIL™ (remestemcel-L) in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles in Biology of Blood and Marrow Transplantation
- Key points: Biology of Blood and Marrow Transplantation, the official publication of the American Society for Transplantation and Cellular Therapy, publishes three.
- 05/25/2020
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Who Has Been Buying Mesoblast Limited (ASX:MSB) Shares?
- It is not uncommon to see companies perform well in the years after insiders buy shares. On the other hand, we'd be...
- 05/20/2020
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Here's Why Mesoblast Is Soaring Today
- Shares of Mesoblast (NASDAQ: MESO) rose as much as 27.2% today after the company announced the pricing of an offering of common stock. The stem cell developer will issue up to 43 million shares of common stock at AUD$3.20 apiece on the Australian Securities Exchange (ASX). The Sydney Morning Herald reported that Mesoblast had to push back "on demand from both new and existing institutional investors."
- 05/13/2020
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Mesoblast Successfully Completes Financing to Scale-Up Manufacturing of Remestemcel-L for COVID-19 ARDS
- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), a leader in cellular medicines for inflammatory diseases, announced today that it has successfully completed a capital raising of US$90 million¹ (A$138 million) via a private placement of 43 million shares to existing and new institutional investors at a price of A$3.20 per share. A significant portion of the net proceeds will be used to scale-up manufacturing of the Company’s lead product candidate remestemcel-L for the treatment of critically ill patients suffering with diseases caused by cytokine release syndromes associated with high mortality, particularly COVID-19 acute respiratory distress syndrome (ARDS). A randomized controlled Phase 2/3 trial in up to 300 patients evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate/severe ARDS is actively enrolling in up to 30 sites in the United States.
- 05/13/2020
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First Patients Dosed in Phase 2/3 Randomized Controlled Trial of Mesoblast’s Remestemcel-l for COVID-19 Acute Respiratory Distress Syndrome
- NEW YORK, May 06, 2020 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the first patients have.
- 05/06/2020
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Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment
- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment. More than 20 medical centers across the United States will participate in the trial which is expected to complete enrollment within three to four months, with interim analyses planned which could result in stopping the trial early for efficacy or futility.
- 04/30/2020
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FDA Expediting Accelerated Development of Novel Therapies for COVID-19
- The U.S. Federal government is working closely with companies and researchers to find treatments and vaccines to overcome the global health crisis. The FDA has been cutting red tape and has launched new programs that relax certain time consuming regulations while still assuring the efficacy and safety
- 04/28/2020
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Can Mesoblast’s COVID-19 Treatment Increase Survival Rate? Analyst Dives In
- Mesoblast's (MESO) shares are cooling off today. After skyrocketing 140% on Friday, the Australian biotech fell 25% today.The lift off came following the release of strong preliminary data concerning its stem cell candidate for treating COVID-19 patients.Mesoblast’s allogeneic mesenchymal stem cell candidate remestemcel-L showed exceptional promise when given to 12 ventilator dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).The 12 patients were given two intravenous infusions of remestemcel-L and within the first five days, ten patients (83%) survived, while nine patients (75%) were removed off ventilator support after a median follow up of ten days. Seven of the patients (58%) were discharged from the hospital.Although a 12 people study is rather small, to put the results into context, in a large study consisting of 5700 patients of ventilator dependent COVID-19 patients, conducted at another New York hospital, the mortality rate was 88%.Additionally, only 9% of COVID-19 patients who received standard-of-care treatment in another hospital, were able to come off ventilator support in a 4103-patient study published in medRxiv in early April.H.C. Wainwright’s Swayampakula Ramakanth believes the early results are encouraging and indicate promise for the success of Mesoblast’s Phase 2/3 study of remestemcel-L in patients with COVID-19 associated ARDS. The study should commence shortly, with enrollment expected to be finalized over the next 3 months. The trial will have the 28-day mortality rate as its primary endpoint.“We are encouraged by these early results and believe that it bodes well for the success of Mesoblast’s Phase 2/3 study of remestemcel-L in patients with COVID-19 associated ARDS. Recall, the Phase 2/3 study is expected to be a 1:1 randomized, placebocontrolled trial in 240 COVID-19 patients with ARDS with a primary endpoint of 28-day mortality rate. Secondary endpoints could include safety, days without ventilator, and survival at different time points. The study is expected to initiate imminently, and management expects to complete patient enrollment in three months. An interim readout is expected at the completion of enrollment of one third of the planned study population. We believe the use of remestemcel-L for the treatment of ARDS could become a significant upside for the company,” said Ramakanth.Ramakanth reiterated a Buy on Mesoblast along with a $14 price target, which implies a potential upside of 21% from current levels. (To Ramakanth’s track record, click here)Only two fellow analysts have published reviews of Mesoblast over the last 3 months, both recommending the stock a Buy. Accordingly, MESO has a Strong Buy consensus rating. The average price target, at $15.00, is a bit more bullish than Ramakanth's – a 29% for Mesoblast shares. (See Mesoblast stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
- 04/27/2020
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Shares of Mesoblast Tumbled Over 20% Today After Doubling Last Week
- The Australian stem-cell therapy developer presented promising data for COVID-19 patients days ago, but investors took some gains off the table today.
- 04/27/2020
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Inovio Pharmaceuticals, Mesoblast, and Moderna: Are These Red-Hot Biotech Stocks Still a Buy?
- The COVID-19 pandemic has been a major catalyst for these three biotech stocks.
- 04/27/2020
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81 Biggest Movers From Friday
- Gainers
Mesoblast Limited (NASDAQ: MESO) shares climbed 139.5% to close at $15.45 on Friday after the company reported 10 out of 12 patients with ventilator-dependent...
- 04/27/2020
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Mid-Afternoon Market Update: Dow Rises 150 Points; Pluristem Therapeutics Shares Spike Higher
- Toward the end of trading Friday, the Dow traded up 0.66% to 23,670 while the NASDAQ rose 1.16% to 8,593.43. The S&P also rose, gaining 0.96% to 2,824.71.
The U.S. is the...
- 04/24/2020
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Afternoon Market Stats in 5 Minutes
- Movers Indices • S&P 500 ETF (NYSE:SPY) rose 0.10% to $279.30.• Nasdaq ETF (NASDAQ:QQQ) increased 0.17% to $210.88.• Dow Jones Industrial Average ETF (NYSE:DIA) fell 0.20% to $234.63.• FTSE/Xinhua China 25 ETF (NYSE:FXI) rose 0.34% to $37.95.• FTSE Europe ETF (NYSE:VGK) increased 0.20% to $44.22.Commodities
- 04/24/2020
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54 Stocks Moving In Friday's Mid-Day Session
- Gainers
Mesoblast Limited (NASDAQ: MESO) jumped 134.8% to $15.14 after the company reported 10 out of 12 patients with ventilator-dependent coronavirus infection survived...
- 04/24/2020
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Mid-Day Market Update: Limelight Networks Falls Following Q1 Earnings; Mesoblast Shares Surge
- Midway through trading Friday, the Dow traded down 0.14% to 23481.83 while the NASDAQ rose 0.13% to 8505.65. The S&P also rose, gaining 0.07% to 2,799.73.
The U.S. is the...
- 04/24/2020
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Stocks That Hit 52-Week Highs On Friday
- During Friday's morning session, 28 stocks hit new 52-week highs.
Noteworthy Mentions:
The largest company by market cap to set a new 52-week high was Eli Lilly (...
- 04/24/2020
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Mid-Morning Market Update: Markets Mostly Flat; Verizon Profit Tops Estimates
- Following the market opening Friday, the Dow traded up 0.05% to 23527.17 while the NASDAQ fell 0.09% to 8487.46. The S&P also rose, gaining 0.05% to 2,799.17.
The U.S. is the...
- 04/24/2020
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CHK, BYND among premarket gainers
- Mesoblast (NASDAQ:MESO) +119% as cell therapy shows significant benefit in COVID-19 patients.Medigus (NASDAQ:MDGS) +73% on COVID-19 plan.Pluristem Therapeutics (NASDAQ:PSTI) +20% on €50 capital raise.
- 04/24/2020
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32 Stocks Moving in Friday's Pre-Market Session
- Gainers
Abraxas Petroleum Corporation (NASDAQ: AXAS) shares rose 63.8% to $0.475 in pre-market trading after jumping 123% on Thursday.
FTS International, Inc. (NASDAQ: FTSI)...
- 04/24/2020
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83% Survival in COVID-19 Patients with Moderate/Severe Acute Respiratory Distress Syndrome Treated in New York with Mesoblast’s Cell Therapy Remestemcel-L
- Key points: 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated with two.
- 04/24/2020
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Biotech ETFs Gaining on Progress in Coronavirus Treatment
- The race to introduce vaccine and treatment for coronavirus is opening up opportunities, making the biotech sector a prospective space for investments.
- 04/21/2020
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Abeona Therapeutics Appoints Brian Pereira and Shawn Tomasello to the Board of Directors
- NEW YORK and CLEVELAND, April 21, 2020 -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced appointments of Brian.
- 04/21/2020
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Mesoblast to Present Positive Clinical Outcomes Using Remestemcel-L in Patients With Inflammatory Lung Disease at 2020 International Society of Cell and Gene Therapy Annual Meeting
- NEW YORK, April 17, 2020 -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB) today announced that results using its allogeneic mesenchymal stem cell product candidate remestemcel-L in.
- 04/17/2020
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The Zacks Analyst Blog Highlights: Pluristem Therapeutics, Mesoblast, Gilead Sciences, Pfizer and Regeneron
- The Zacks Analyst Blog Highlights: Pluristem Therapeutics, Mesoblast, Gilead Sciences, Pfizer and Regeneron
- 04/15/2020
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The Zacks Analyst Blog Highlights: Pluristem Therapeutics, Mesoblast, Gilead Sciences, Pfizer and Regeneron
- The Zacks Analyst Blog Highlights: Pluristem Therapeutics, Mesoblast, Gilead Sciences, Pfizer and Regeneron
- 04/15/2020
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Pluristem Up on Cell Therapy Treatment of Coronavirus Patient
- Pluristem (PSTI) gains on the treatment of first patient suffering from COVID-19 complications with its cell therapy.
- 04/14/2020
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Will Stem Cell Therapies Aid in Fight Against Coronavirus?
- With the coronavirus outbreak gaining steam worldwide, pharma/biotech companies are evaluating every possible therapy to combat the spread.
- 04/14/2020
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Update: Mesoblast (ASX:MSB) Stock Gained 57% In The Last Year
- These days it's easy to simply buy an index fund, and your returns should (roughly) match the market. But investors...
- 04/13/2020
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More than 20 Companies Are Working on Coronavirus Treatments or Vaccines
- COVID-19 cases make up over 1,617,204 today, with 466,299 of them in the U.S. Over 20 companies are working on coronavirus vaccine or drugs.
- 04/10/2020
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Pluristem Therapeutics Shares Jump on Covid-19 Study Results
- The Israeli company reported its placenta-based treatment seemed to reduce complications in a small study Continue reading...
- 04/10/2020
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NRZ, RIG among premarket gainers
- Tiziana Life Sciences PLC (NASDAQ:TLSA) +68% on inhalable treatment for COVID-19.Nautilus (NYSE:NLS) +43% after stay-at-home effect on sales.Exantas Capital (NYSE:XAN) +37%.Transocean (NYSE:RIG) +30%.
- 04/09/2020
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The Daily Biotech Pulse: FDA Nod For Pfizer, Vanda Forges Partnership For COVID-19 Drug Research, Neuronetics Pre-Announces Revenue Shortfall
- Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 8) * Keros Therapeutics Inc (NASDAQ: KROS) (went public Wednesday and traded 25.5% higher to $20.08, up from the IPO price of $16)None of the NYSE- or Nasdaq-listed
- 04/09/2020
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MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTH’S NATIONAL HEART, LUNG AND BLOOD INSTITUTE TO CONDUCT RANDOMIZED CONTROLLED TRIAL OF REMESTEMCEL-L FOR PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO COVID-19
- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.
- 04/08/2020
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Mesoblast's COVID-19 Foray, And Other News: The Good, Bad And Ugly Of Biopharma
- Mesoblast was up on an IND approval targeting COVID-19. Crinetics announced positive trial data. Bellerophon announced earnings and program updates.
- 04/08/2020
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84 Biggest Movers From Yesterday
- Gainers
Immunomedics, Inc. (NASDAQ: IMMU) shares jumped 99.8% to close at $18.78 on Monday after the company said it would stop its Ascent Study due to compelling evidence of...
- 04/07/2020
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Afternoon Market Stats in 5 Minutes
- Movers Indices • S&P 500 ETF (NYSE:SPY) rose 4.98% to $260.29.• Nasdaq ETF (NASDAQ:QQQ) rose 4.92% to $192.38.• Dow Jones Industrial Average ETF (NYSE:DIA) increased 4.94% to $221.07.• FTSE/Xinhua China 25 ETF (NYSE:FXI) increased 3.18% to $38.09.• FTSE Europe ETF (NYSE:VGK) rose 4.14% to $42.98.Commodities
- 04/06/2020
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TWO and LADR among premarket gainers
- Immunomedics (NASDAQ:IMMU) +111% on positive ADC data in breast cancer.Two Harbors Investment (NYSE:TWO) +39% on Q1 update.Mesoblast (NASDAQ:MESO) +36% on testing remestemcel-L in COVID-19 patients.Wa
- 04/06/2020
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26 Stocks Moving in Monday's Pre-Market Session
- Gainers
Mesoblast Limited (NASDAQ: MESO) shares rose 54.8% to $6.50 in pre-market trading after the company received the FDA approval for an investigational new drug application...
- 04/06/2020
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FDA CLEARS INVESTIGATIONAL NEW DRUG APPLICATION FOR MESOBLAST TO USE REMESTEMCEL-L IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME CAUSED BY COVID-19
- NEW YORK, April 06, 2020 -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that it has received.
- 04/06/2020
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Mesoblast's (MESO) BLA for Ryoncil Gets FDA Priority Review
- The FDA accepts Mesoblast's (MESO) BLA for Ryoncil (remestemcel-L) under a priority review to treat children with steroid-refractory acute graft versus host disease. A decision is pending on Sep 30.
- 04/03/2020
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Mesoblast's (MESO) BLA for Ryoncil Gets FDA Priority Review
- The FDA accepts Mesoblast's (MESO) BLA for Ryoncil (remestemcel-L) under a priority review to treat children with steroid-refractory acute graft versus host disease. A decision is pending on Sep 30.
- 04/03/2020
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The Daily Biotech Pulse: InflaRx Begins Human Testing For COVID-induced Pneumonia, Chembio, Becton Dickinson Launch Coronavirus Tests
- Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs March 31) * Athersys Inc (NASDAQ: ATHX) * Forty Seven Inc (NASDAQ: FTSV) * Ra Pharmaceuticals Inc (NASDAQ: RARX) * Quidel Corporation (NASDAQ: QDEL)Down In
- 04/01/2020
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FDA ACCEPTS MESOBLAST’S BIOLOGICS LICENCE APPLICATION FOR RYONCIL™ AND AGREES TO PRIORITY REVIEW
- NEW YORK, April 01, 2020 -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States.
- 04/01/2020
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The Daily Biotech Pulse: Milestone Pharma Flunks Late-Stage Study, CytomX Strikes Cancer Drug Collaboration, BARDA Grant For GenMark's COVID-19 Test
- Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs March 23.) * Arcutis Biotherapeutics Inc (NASDAQ: ARQT) * Bellerophon Therapeutics Inc (NASDAQ: BLPH) (follow-on rally from Friday's news of FDA authorization
- 03/24/2020
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FCAU, HLT among premarket losers
- BioNTech SE (NASDAQ:BNTX) -16%.Mesoblast (NASDAQ:MESO) -17%.InterContinental Hotels Group (NYSE:IHG) -15%.Starwood Property Trust (NYSE:STWD) -15%.Sasol (NYSE:SSL) -12%.iBio (NYSEMKT:IBIO) -13%.Barcla
- 03/19/2020
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Global Stem Cells Industry
- New York, March 11, 2020 -- Reportlinker.com announces the release of the report "Global Stem Cells Industry" - https://www.reportlinker.com/p02043289/?utm_source=GNW 3%. The.
- 03/12/2020
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Crude crash and coronavirus weigh on Energy and biotech stocks premarket
- Quorum Health (NYSE:QHC) -53%.Sasol (NYSE:SSL) -22%.Enable Midstream (NYSE:ENBL) -20%.Mesoblast (NASDAQ:MESO) -15% after 12% upmove yesterday.OpGen (NASDAQ:OPGN) -15%.Occidental Petroleum (NYSE:OXY) -
- 03/11/2020
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Diabetes Industry Report 2020: The Latest Development, Product Innovations and Treatments - ResearchAndMarkets.com
- The "Latest Development, Product Innovations and Treatments for Diabetes" report has been added to ResearchAndMarkets.com's offering.
- 03/02/2020
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Comprehensive Study of the Global Diabetes Market (2018-2024) Featuring Profiles of Key Players Abbott Labs, BD & Co, Eli Lilly & Co, GSK, NextCell Pharma, and More
- The "Latest Development, Product Innovations and Treatments for Diabetes" report has been added to ResearchAndMarkets.com's offering.
- 02/26/2020
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Global Diabetes Market Trends & Growth Projections, 2018-2019 & 2020-2024
- Dublin, Feb. 26, 2020 -- The "Latest Development, Product Innovations and Treatments for Diabetes" report has been added to ResearchAndMarkets.com's offering.This.
- 02/26/2020
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Mesoblast Submits BLA, And Other News: The Good, Bad And Ugly Of Biopharma
- Mesoblast just filed completed BLA with the FDA. Waters Corporation, a healthcare-related company, slumps on poor earnings. Eyepoint starts a new collaboration.
- 02/05/2020
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The Daily Biotech Pulse: FDA Nod For Epizyme, Sonoma Explores Options For Dermatology Business, Roche's Cancer Drug Flunks Study
- Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on Jan. 23) Baudax Bio Inc (NASDAQ: BXRX ) Mesoblast limited (NASDAQ: ...
- 01/24/2020
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The Daily Biotech Pulse: Novo Nordisk's Ozempic Receives Label Expansion For Cardiovascular Events, Adcom Disappointment Inflicts Pain On Durect Shares
- The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 16.) Acceleron Pharma Inc (NASDAQ: XLRN ) Aimmune ...
- 01/17/2020
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The Daily Biotech Pulse: Osmotica Soars On Insider Buys, Ultragenyx's Partnered Rare Disease Drug Moves Into Clinics
- Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on Jan. 15) 10X Genomics Inc (NASDAQ: TXG ) Aimmune Therapeutics ...
- 01/16/2020
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The Daily Biotech Pulse: PhaseBio To Buy Hypertension Asset, Stemline Falls On Q4 Pre-Announcement, FDA Panel To Review Nektar's Opioid Drug
- The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 13.) Arvinas Inc (NASDAQ: ARVN ) Baxter International ...
- 01/14/2020
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Zacks.com featured highlights include: CNX Midstream Partners LP, Akoustis Technologies, CRH Medical, Mesoblast and Photronics
- Zacks.com featured highlights include: CNX Midstream Partners LP, Akoustis Technologies, CRH Medical, Mesoblast and Photronics
- 01/09/2020
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