Penny Stock Equillium Falls After Itolizumab Treatment Fails To Show Improvement In Response Rates In Graft Versus Host Disease Patients
- Equillium, Inc. EQ released topline data on Thursday from the Phase 3 EQUATOR study. The study evaluated itolizumab in the first-line treatment of patients with acute graft-versus-host disease (aGVHD).
- 03/27/2025
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Equillium Announces Results of the Phase 3 EQUATOR Study of Itolizumab in First-Line Treatment of Patients with Acute Graft-Versus-Host Disease
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ #GVHD--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced topline data from the Phase 3 EQUATOR study evaluating itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD). The study results did not demonstrate a meaningful difference in complete response (CR) or overal.
- 03/27/2025
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Here's Why Equillium (EQ) Is a Great 'Buy the Bottom' Stock Now
- Equillium (EQ) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.
- 02/21/2025
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Equillium (EQ) Upgraded to Buy: Here's What You Should Know
- Equillium (EQ) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
- 02/10/2025
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Equillium (EQ) Shows Fast-paced Momentum But Is Still a Bargain Stock
- Equillium (EQ) made it through our 'Fast-Paced Momentum at a Bargain' screen and could be a great choice for investors looking for stocks that have gained strong momentum recently but are still trading at reasonable prices.
- 02/10/2025
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Equillium Reports Third Quarter 2024 Financial Results and Provides Corporate and Clinical Updates
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2024 and provided corporate and clinical updates. “At the end of October we announced that our partnership with Ono Pharmaceutical had ended following substantial non-dilutive financing that has fully fund.
- 11/13/2024
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Equillium, Inc. (EQ) to Report Q3 Results: Wall Street Expects Earnings Growth
- Equillium (EQ) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
- 11/06/2024
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Equillium, Inc. (EQ) Beats Q2 Earnings and Revenue Estimates
- Equillium, Inc. (EQ) came out with quarterly earnings of $0.01 per share, beating the Zacks Consensus Estimate of a loss of $0.15 per share. This compares to loss of $0.10 per share a year ago.
- 08/08/2024
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Equillium Announces Second Quarter 2024 Estimated Cash and Investments Balance
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ #GVHD--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced second quarter 2024 estimated ending cash, cash equivalents and short-term investments of approximately $33.3 million, representing an increase of approximately $1.0 million from the end of the first quarter of 2024. The increase is primarily the result of receiving a tax credit of.
- 07/18/2024
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Equillium to be included in the Russell Microcap® Index
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it expects to join the Russell Microcap Index at the conclusion of the 2024 Russell annual reconstitution, effective at the open of equity markets on Monday, July 1, according to a preliminary list of additions posted Friday, May 24. The annual Russell reconstitution captures t.
- 06/12/2024
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Equillium Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that on May 31, 2024, the Compensation Committee of Equillium's Board of Directors granted an inducement award consisting of a nonstatutory stock option to purchase 7,200 shares of common stock to a new employee under Equillium's 2024 Inducement Plan. The Compensation Committee appr.
- 06/05/2024
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Equillium Announces Positive Topline Data from Phase 2 Study of EQ101 in Alopecia Areata
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from its Phase 2, single dose, proof-of-concept (PoC) study of EQ101 in adult patients with moderate, severe or very-severe alopecia areata (AA), an autoimmune disease driven by an immune cell attack of the hair follicles th.
- 06/04/2024
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Equillium to Present at the Jefferies Global Healthcare Conference
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it will present at the Jefferies Global Healthcare Conference taking place at the Marriott Marquis in New York, NY, June 4 – 6, 2024. Management will provide an overview of the company's clinical programs – including EQ101 for the treatment for alopecia areata with data expecte.
- 05/29/2024
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Equillium Announces Interim Enrollment Achieved in Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it has surpassed the interim enrollment target for the Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease (aGVHD). Equillium expects to deliver the results of the EQUATOR interim data review to Ono during the third quarter, which will then trigger Ono's thre.
- 05/14/2024
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Equillium, Inc. (EQ) Reports Q1 Loss, Tops Revenue Estimates
- Equillium, Inc. (EQ) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.11 per share a year ago.
- 05/09/2024
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Equillium Reports First Quarter 2024 Financial Results and Provides Recent Clinical Highlights
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the first quarter 2024 and highlights in clinical development. “With multiple milestones expected in 2024, we are happy to have reported our first milestone of positive topline data from the Phase 1b EQUALISE study in lupus.
- 05/09/2024
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Equillium Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that on April 1, 2024, the Compensation Committee of Equillium's Board of Directors granted an inducement award consisting of a nonstatutory stock option to purchase 10,000 shares of common stock to a new employee under Equillium's 2024 Inducement Plan. The Compensation Committee ap.
- 04/03/2024
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5 Stocks That More Than Doubled in Q1 With More Gains Ahead
- Equillium (EQ), Laird Superfood (LSF), QuantaSing (QSG), Phunware (PHUN) and Arq (ARQ) more than double in the first quarter and are expected to continue their strong performances.
- 04/01/2024
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Equillium, Inc. (EQ) Reports Q4 Loss, Tops Revenue Estimates
- Equillium, Inc. (EQ) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to earnings of $0.08 per share a year ago.
- 03/25/2024
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Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights. “The past year we have been focused on clinical execution that has set up the potential milestones we have in front of us in 2024,” said B.
- 03/25/2024
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Equillium to Present at the H.C. Wainwright Autoimmune & Inflammatory Disease Conference and the LD Micro Invitational Conference
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it will present at the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference, and the LD Micro Invitational Conference. Management will provide an overview of the company's clinical programs, partnership with Ono Pharmaceutical and 2024 milestones, during bot.
- 03/22/2024
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5 Stocks That More Than Doubled in February
- Janux Therapeutics (JANX), SoundHound (SOUN), ROOT, Equillium (EQ) and CleanSpark (CLSK) more than doubled in February.
- 03/01/2024
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5 Top-Ranked Stocks That Have More Than Doubled Year to Date
- Amid the broad-market rally, shares of Equillium (EQ), Phunware (PHUN), Super Micro Computer (SMCI), Vaxart (VXRT) and Dianthus Therapeutics (DNTH) have more than doubled this year.
- 02/23/2024
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Equillium Announces Update on Multi-Cytokine Inhibitors EQ101 & EQ102 in Development for Alopecia Areata and Celiac Disease
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced an update on multi-cytokine programs EQ101 in development for the treatment of alopecia areata, EQ102 in development for the treatment of celiac disease, and EQ302, a new orally delivered multi-cytokine inhibitor. “We are pleased to have completed enrollment of the EQ101 Phase 2 stu.
- 12/21/2023
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Equillium Presents Positive Data from Phase 1b EQUALISE Study at the 2023 Annual Meeting of the American College of Rheumatology
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ #lupus--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that data from the Type B portion of the EQUALISE study evaluating itolizumab in lupus nephritis patients was presented at ACR Convergence, the annual meeting of the American College of Rheumatology (ACR). The data presented by Dr. Kenneth Kalunian, Professor, Medicine, UCSD School.
- 11/13/2023
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Equillium Reports Third Quarter 2023 Financial Results and Provides Corporate and Clinical Updates
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2023 and provided corporate and clinical development updates. “The third quarter was focused on clinical execution and expanding education on our multi-cytokine platform and clinical programs ahead of init.
- 11/08/2023
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Equillium Announces Data from Phase 1b EQUALISE Study Presented at the 2023 Annual Meeting of the American Society of Nephrology
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ #GVHD--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that data from the Type B portion of the EQUALISE study in lupus nephritis patients was presented at the annual meeting of the American Society of Nephrology (ASN). The data highlights that subjects had high complete and partial response rates with rapid and deep reduction in urine.
- 11/06/2023
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Equillium Announces Preclinical Data from New Orally Deliverable Multi-Cytokine Inhibitor in Presentation at the 18th Annual Peptide Therapeutics Symposium
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced a presentation at the 18th Annual Peptide Therapeutics Symposium highlighting EQ302, a second generation orally deliverable multi-cytokine inhibitor in development to target IL-15 and IL-21. The symposium, bringing together leaders in peptide research from academia and industry to fo.
- 10/16/2023
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Equillium to Present at the JonesTrading 2023 Healthcare Summit
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it will present at the JonesTrading 2023 Healthcare Summit taking place October 9 - 11 at the Eden Roc hotel in Miami, Florida. In addition to one-on-one investor meetings, management will participate in a panel presentation focused on industry trends that influence drug discov.
- 10/02/2023
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Equillium to Present at the Cantor Fitzgerald Global Healthcare & LD Micro Main Event Conferences
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it will present at the Cantor Fitzgerald Global Healthcare Conference and the LD Micro Main Event Conference. Management will participate in a panel presentation at the Cantor Fitzgerald Conference where they will provide an overview of the Company's multi-cytokine inhibitor pl.
- 09/20/2023
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Equillium to Attend Wells Fargo Healthcare Conference & Present at H.C. Wainwright 25th Annual Global Investor Conference
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that it will host investor meetings at the Wells Fargo Healthcare Conference, and present and host meetings at the H.C. Wainwright 25th Annual Global Investor Conference. Management will provide an overview of the Company's multi-cytokine inhibi.
- 08/30/2023
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Equillium, Inc. (EQ) Reports Q2 Loss, Tops Revenue Estimates
- Equillium, Inc. (EQ) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.41 per share a year ago.
- 08/09/2023
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Equillium Announces $7.5 Million Share Repurchase Program
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that its Board of Directors authorized the repurchase of up to $7.5 million of shares of the Company's common stock. “The share repurchase program demonstrates our belief in the intrinsic value and potential of Equillium and underscores our comm.
- 08/02/2023
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Equillium, Inc. (EQ) Reports Q1 Loss, Tops Revenue Estimates
- Equillium, Inc. (EQ) came out with a quarterly loss of $0.11 per share versus the Zacks Consensus Estimate of a loss of $0.20. This compares to loss of $0.45 per share a year ago.
- 05/11/2023
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Equillium to Present at Two Upcoming Investor Conferences
- LA JOLLA, Calif.
- 11/08/2022
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Why Is Equillium (EQ) Stock Soaring 20% Today?
- Clinical-stage biotechnology firm Equillium (NASDAQ: EQ ), which focuses on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, released encouraging clinical data regarding itolizumab. A monoclonal antibody, itolizumab aims to provide positive outcomes for patients suffering from lupus nephritis (or LN).
- 09/27/2022
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Equillium's stock is up 12% after sharing early data about its investigational lupus treatment
- Shares of Equillium Inc. EQ, -3.98% gained 12.9% in premarket trading on Tuesday after the company shared a batch of interim data from an early stage trial evaluating its experimental treatment in 13 people with lupus nephritis. Equillium said 83% of the participants enrolled in the study achieved complete or partial response, and about two-thirds had a 80% reduction in urine protein creatinine ratio by week 28.
- 09/27/2022
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Equillium to Present at Two Upcoming Investor Conferences
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ #GVHD--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it will participate in a fireside chat presentation at the Wells Fargo Healthcare Conference and a corporate presentation at the H.C. Wainwright Annual Global Investment Conference. Management will provide a high-level overview of the company, clini
- 08/31/2022
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Down 20.5% in 4 Weeks, Here's Why You Should You Buy the Dip in Equillium, Inc. (EQ)
- Equillium, Inc. (EQ) 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.
- 03/29/2022
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Equillium to Present at the SVB Leerink Virtual Global Healthcare Conference
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it will participate in a fireside chat presentation at the SVB Leerink Virtual Global Healthcare Conference, taking place February 14 – 18, 2022. Bruce Steel, Equillium's chief executive officer, and Steve Connelly Ph.D., Equillium's chief scientific officer, will pro
- 02/09/2022
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Equillium To Reassess Potential For Its Asthma Trials
- Equillium Inc's (NASDAQ: EQ) Phase 1b EQUIP study of itolizumab in patients with uncontrolled asthma met its primary objective. The data demonstrated an on-target peak and sustained reduction of CD6 at Day 85 (one month following the last dose).
- 01/04/2022
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Equillium to Present at the Cantor Fitzgerald Virtual Global Healthcare Conference
- LA JOLLA, Calif.--(BUSINESS WIRE)---- $EQ--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it will participate in a fireside chat presentation at the Cantor Fitzgerald Virtual Global Healthcare Conference, taking place September 27 – 30, 2021. Bruce Steel, Equillium's chief executive officer, and Dolca Thomas M.D., Equillium's executive vice president of re
- 09/22/2021
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Equillium's Itolizumab Reduces Urine Protein In Lupus Patients
- Equillium Inc (NASDAQ: EQ) announced additional data from the Type A portion of the EQUALISE Phase 1b study of itolizumab in systemic lupus erythematosus (SLE) and lupus nephritis (LN). The new data showed that patients without a diagnosis of LN but with elevated urine protein/creatine ratio (UPCR) experienced a mean decrease from baseline in UPCR of 33% and 42% at Days 29 and 57, respectively.
- 08/12/2021
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Equillium's Single Phase 3 Study In aGVHD To Support US Filing Of Itolizumab
- Equillium Inc (NASDAQ: EQ) completed an End-of-Phase 1 meeting with the FDA, confirming to advance itolizumab into a single Phase 3 pivotal study in first-line treatment of acute graft-versus-host disease (aGVHD) patients. The company plans to initiate the Phase 3 study in 4Q of 2021.
- 07/13/2021
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EQ Stock Increases Over 7% Pre-Market: Why It Happened
- The stock price of Equillium Inc (NASDAQ: EQ) increased by over 7% pre-market. This is why it happened.
- 07/13/2021
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Equillium Announces Plans to Initiate Phase 3 Pivotal Study of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease Following End-of-Phase 1 Meeting with the FDA
- Single pivotal Phase 3 study in acute graft-versus-host disease to support filing of biologics license application
- 07/12/2021
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4 Biotech and Life Sciences Stocks Trading Under $10 With Gigantic Upside Potential
- While most of Wall Street focuses on large-cap and mega-cap stocks, as they provide a degree of safety and liquidity, many investors are limited in the number of shares they can buy.
- 06/19/2021
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Equillium's Itolizumab Shows Rapid, Durable Responses In Graft-Versus-Host-Disease Patients
- Equillium Inc (NASDAQ: EQ) has announced positive topline data from the Phase 1b EQUATE study evaluating itolizumab in first-line acute graft-versus-host-disease (aGVHD). The results were presented at the European Hematology Association 2021 Virtual Congress.
- 06/11/2021
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Equillium Announces Positive Topline Results from the EQUATE Study in First-line Treatment of Acute Graft-Versus-Host Disease
- Itolizumab continues to demonstrate favorable safety and efficacy profile
- 06/11/2021
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Equillium Presents Data on Target Engagement and Modulation of CD6 on T Cells with Itolizumab at the International Society for Advancement of Cytometry
- Whole blood and proteomic stabilized blood assay used to elicit clinical pharmacodynamic CD6 biomarker in autoimmune diseases Whole blood and proteomic stabilized blood assay used to elicit clinical pharmacodynamic CD6 biomarker in autoimmune diseases
- 06/10/2021
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Equillium to Present at the JMP Securities Life Sciences Conference
- LA JOLLA, Calif., June 09, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, announced today that it will present at the JMP Securities Life Sciences Conference, a virtual investor event, taking place June 16 and 17, 2021.
- 06/09/2021
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Equillium Reports First Quarter 2021 Financial Results and Provides Clinical Development Update
- Announced favorable data from Phase 1b EQUALISE study in patients with systemic lupus erythematosus
- 05/13/2021
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Equillium Announces Oral Presentation Highlighting Positive Data from the EQUATE Study in Acute Graft-Versus-Host Disease at the EHA2021 Virtual Congress of the European Hematology Association
- LA JOLLA, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that an abstract highlighting positive data from the EQUATE study of itolizumab in acute graft-versus-host disease (aGVHD) has been accepted for oral presentation at EHA2021 Virtual Congress. The annual meeting of the European Hematology Association will be held virtually June 9 – 17, 2021.
- 05/13/2021
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Equillium Announces Three Abstracts Accepted for Presentation at the 104th Annual Meeting of the American Association of Immunologists
- Presentations highlight the pathogenic role of the CD6-ALCAM pathway, the immunologic impact of modulating this pathway with itolizumab, and pharmacodynamic assays to monitor this in patients Presentations highlight the pathogenic role of the CD6-ALCAM pathway, the immunologic impact of modulating this pathway with itolizumab, and pharmacodynamic assays to monitor this in patients
- 04/27/2021
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EQ Stock Price Increased Over 5% Pre-Market: Why It Happened
- The stock price of Equillium, Inc. (Nasdaq: EQ) has increased by over 5% pre-market. This is why it happened.
- 03/31/2021
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Equillium's Itolizumab Shows Encouraging Safety, Tolerability Profile In Systemic Lupus Erythematosus Study
- Equillium Inc (NASDAQ: EQ) has reported topline data from the Type A group of the Phase 1b EQUALISE study evaluating itolizumab in patients with systemic lupus erythematosus (SLE). Data from the study showed that itolizumab was safe and well-tolerated and demonstrated a dose-dependent reduction of cell-surface CD6 expression on effector T cells, a leading indicator of drug activity.
- 03/31/2021
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Equillium Announces Favorable Data From Phase 1b EQUALISE Study in Systemic Lupus Erythematosus Patients
- Itolizumab administered subcutaneously was safe and well tolerated in patients with systemic lupus erythematosus
- 03/30/2021
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Equillium Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Clinical Development Update
- Cash runway into the second half of 2023
- 03/24/2021
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Equillium Presents Positive Interim Clinical Data of Itolizumab in First-line Treatment of Acute Graft-Versus-Host Disease at the 2021 Transplantation and Cellular Therapy Meetings Digital Experience
- Higher dose cohorts demonstrated 100% overall response rate, resulting in substantial reduction in baseline corticosteroid use
- 02/12/2021
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Equillium Announces the Appointment of Katherine Xu to the Board of Directors
- LA JOLLA, Calif., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that Y. Katherine Xu, Ph.D., partner at Decheng Capital, has been appointed to Equillium's board of directors, effective Thursday, February 4, 2021.
- 02/09/2021
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Equillium Announces Closing of $30 Million Registered Direct Offering
- LA JOLLA, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced the closing of its previously announced registered direct offering with life science institutional investment funds managed by Decheng Capital, to purchase 4,285,710 units (the “Units”) from Equillium, with each Unit consisting of one share of common stock and a warrant to purchase 0.3 of a share of common stock. The purchase price per Unit was $7.00, priced above the market under Nasdaq rules. The warrants have an exercise price of $14.00 per share, are immediately exercisable, and will expire on the earlier of (i) the fifth anniversary of issuance, or (ii) the 15th calendar date following the date on which Equillium closes a financing raising a minimum of $25 million at a price per share of no less than $25.00.
- 02/05/2021
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Equillium Raises $30M Via Equity, Shares Rally
- Equillium Inc (NASDAQ: EQ) has entered into a securities purchase agreement with Decheng Capital to purchase around 4.3 million units from Equillium at $7 per unit, equivalent to gross proceeds of $30 million. EQ's closing price as of Wednesday was $6.62 per share.
- 02/04/2021
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Equillium Announces Pricing of $30 Million Registered Direct Offering
- LA JOLLA, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that it has entered into a securities purchase agreement with life science institutional investment funds managed by Decheng Capital, to purchase 4,285,710 units (the “Units”) from Equillium, with each Unit consisting of one share of common stock and a warrant to purchase 0.3 of a share of common stock. The purchase price per Unit is $7.00, priced above the market under Nasdaq rules. The warrants will have an exercise price of $14.00 per share, will be immediately exercisable, and will expire on the earlier of (i) the fifth anniversary of issuance, or (ii) the 15th calendar date following the date on which Equillium closes a financing raising a minimum of $25 million at a price per share of no less than $25.00.
- 02/04/2021
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Equillium Announces Acceptance of Late-Breaking Abstract for Oral Presentation of Interim Data from EQUATE Study in acute GVHD at the 2021 TCT Meetings Digital Experience
- LA JOLLA, Calif., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ) a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that interim data from the Phase 1b/2 EQUATE study of itolizumab in acute graft-versus-host disease (aGVHD) has been accepted as a late-breaking oral presentation at the 2021 TCT Meetings Digital Experience, being held February 8-12, 2021.
- 01/22/2021
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Equillium Presents Translational Data Demonstrating Impact of Itolizumab on Effector T Cell Function at the 2020 American Society of Hematology Annual Meeting and Exposition
- Studies further support itolizumab's potential as treatment for aGVHD patients Studies further support itolizumab's potential as treatment for aGVHD patients
- 12/07/2020
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Equillium (EQ) Stalls Initiation of Phase III Study on COVID-19
- Equillium (EQ) decides to not initiate a phase III study on its candidate, itolizumab, for the treatment of hospitalized COVID-19 patients at this time.
- 11/26/2020
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Equillium's stock tumbles after decision to not initiate late-stage trial of COVID-19 treatment
- Shares of Equillium Inc. tumbled 12.6% in premarket trading Wednesday, after the biotechnology company said it decided not to initiate a Phase 3 trial its itolizumab for the treatment of hospitalized COVID-19 patients "at this time." The company said its decision was based on a review of recent updates regarding the efficacy of COVID-19 vaccine candidates and other treatment options.
- 11/25/2020
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Equillium Provides Itolizumab COVID-19 Program Update
- Analyst Day scheduled for December 4, 2020 Analyst Day scheduled for December 4, 2020
- 11/25/2020
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Equillium Reports Third Quarter 2020 Financial Results and Business Highlights
- LA JOLLA, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2020.
- 11/10/2020
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Equillium to Present at Investor Conferences in November 2020
- LA JOLLA, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that Bruce Steel, Equillium's chief executive officer and Krishna Polu, M.D., Equillium's chief medical officer, will present at two upcoming investor conferences in November 2020.
- 11/10/2020
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Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease
- 100% overall response rate in dose cohort 3 and 80% overall response rate across all cohorts to date
- 11/06/2020
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Equillium to Present Data at the 2020 American College of Rheumatology Meeting Demonstrating CD6 Modulation Improves Kidney and Skin Pathology in Preclinical Models of Systemic Lupus Erythematosus
- Studies further validate ongoing clinical development of itolizumab for the treatment of systemic lupus erythematosus and lupus nephritis
- 11/04/2020
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EQ Stock: 6 Things to Know about Biotech Company Equillium
- Equillium (EQ) stock is seeing gains on Friday after getting the go-ahead from the FDA for a drug trial treating the coronavirus. The post EQ Stock: 6 Things to Know about Biotech Company Equillium appeared first on InvestorPlace.
- 10/30/2020
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What This FDA Update Means for Equillium's COVID-19 Study
- Equillium Inc. (NASDAQ: EQ) shares jumped on Friday after the company announced a key update from the U.S.
- 10/30/2020
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Equillium Receives FDA Clearance of COVID-19 IND for Phase 3 Trial
- Equillium p lans to initiate global Phase 3 COVID-19 trial – EQUINOX – during Q4 2020
- 10/29/2020
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The Daily Biotech Pulse: Gilead's Filgotinib Stumbles With FDA, J&J Laps Up Momenta In $6.5B Deal, 2 IPOs
- Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Aug. 18)
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- 08/19/2020
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Equillium Announces Closing of Public Offering of Common Stock
- LA JOLLA, Calif., Aug. 18, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced the closing of its previously announced underwritten public offering of 5,000,000 shares of common stock at a public offering price of $7.00 per share. The aggregate gross proceeds to Equillium from this offering, before deducting underwriting discounts and commissions and other offering expenses, were $35 million. Jefferies, SVB Leerink and Stifel acted as the joint book-running managers for this offering. H.C. Wainwright & Co. acted as a financial advisor to Equillium for this offering.A registration statement on Form S-3 has been filed with the Securities and Exchange Commission (SEC) and was declared effective on November 25, 2019. The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at syndicate@svbleerink.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com.This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About EquilliumEquillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab has been clinically validated with a favorable safety and tolerability profile based on its approved uses in India. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.Notice Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include market conditions, general economic factors, the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available, the possibility that Equillium’s existing and new applications to the U.S. Food and Drug Administration and other regulatory agencies may not receive approval in a timely manner or at all, potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom, uncertainties related to the completeness and accuracy of Biocon data and review by Equillium of Biocon data, and uncertainties related to Equillium’s capital requirements, Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials, including a clinical trial of patients with COVID-19, uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic, uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause, whether the results from clinical trials will validate and support the safety and efficacy of itolizumab, changes in the competitive landscape, reliance on third parties for manufacturing and development efforts and uncertainties having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor ContactChristine Zedelmayer, Chief Operating Officer +1-858-412-5302 ir@equilliumbio.comMedia ContactCammy Duong Canale Communications +1-619-849-5389 cammy@canalecomm.com
- 08/18/2020
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Equillium Announces Pricing of Public Offering of Common Stock
- LA JOLLA, Calif., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced the pricing of an underwritten public offering of 5,000,000 shares of common stock at a public offering price of $7.00 per share. In addition, Equillium has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock at the public offering price less the underwriting discount. Equillium anticipates its gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, to be approximately $35 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about August 18, 2020, subject to customary closing conditions. Equillium expects to use the net proceeds from this offering to primarily fund the continued development of current and any future product candidates in its pipeline, potential acquisitions of new products, and for working capital, capital expenditures and general corporate purposes.Jefferies, SVB Leerink and Stifel are acting as the joint book-running managers for this offering. H.C. Wainwright & Co. is acting as financial advisor to Equillium for this offering.A registration statement on Form S-3 has been filed with the Securities and Exchange Commission (SEC) and was declared effective on November 25, 2019. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on August 13, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at syndicate@svbleerink.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com.Before investing in this offering, you should read in their entirety the final prospectus supplement and the accompanying prospectus and the other documents that Equillium has filed with the SEC that are incorporated by reference in the final prospectus supplement and the accompanying prospectus, which provide more information about Equillium and such offering.This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About EquilliumEquillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab has been clinically validated with a favorable safety and tolerability profile based on its approved uses in India. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.Notice Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the expected closing date of the public offering and the intended use of net proceeds therefrom. Risks that contribute to the uncertain nature of the forward-looking statements include market conditions, the satisfaction of customary closing conditions related to the proposed public offering, as well as general economic factors, the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available, the possibility that Equillium’s existing and new applications to the U.S. Food and Drug Administration and other regulatory agencies may not receive approval in a timely manner or at all, potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom, uncertainties related to the completeness and accuracy of Biocon data and review by Equillium of Biocon data, and uncertainties related to Equillium’s capital requirements, Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials, including a clinical trial of patients with COVID-19, uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic, uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause, whether the results from clinical trials will validate and support the safety and efficacy of itolizumab, changes in the competitive landscape, reliance on third parties for manufacturing and development efforts and uncertainties having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor ContactChristine Zedelmayer, Chief Operating Officer +1-858-412-5302 ir@equilliumbio.comMedia ContactCammy Duong Canale Communications +1-619-849-5389 cammy@canalecomm.com
- 08/14/2020
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Equillium Announces Proposed Public Offering of Common Stock
- LA JOLLA, Calif., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that it intends to offer and sell shares of its common stock in an underwritten registered public offering. All of the shares in the offering are to be sold by Equillium. Equillium also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Equillium expects to use the net proceeds from this offering to primarily fund the continued development of current and any future product candidates in its pipeline, potential acquisitions of new products, and for working capital, capital expenditures and general corporate purposes.Jefferies, SVB Leerink and Stifel are acting as the joint book-running managers for this offering. H.C. Wainwright & Co. is acting as financial advisor to Equillium for this offering.A registration statement on Form S-3 has been filed with the Securities and Exchange Commission (SEC) and was declared effective on November 25, 2019. The offering of these securities will be made only by means of a preliminary prospectus supplement and accompanying prospectus forming part of the effective registration statement relating to the shares. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6218 or by email at syndicate@svbleerink.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, A 94104, by telephone at 415-364-2720 or by email at syndprospectus@stifel.com.Before investing in this offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Equillium has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Equillium and such offering.This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About EquilliumEquillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab has been clinically validated with a favorable safety and tolerability profile based on its approved uses in India. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.Notice Regarding Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, the timing and success of the anticipated public offering and the intended use of net proceeds therefrom. Risks that contribute to the uncertain nature of the forward-looking statements include market conditions, the satisfaction of customary closing conditions related to the proposed public offering, as well as general economic factors, the risk that interim results of a clinical trial do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available, the possibility that Equillium’s existing and new applications to the U.S. Food and Drug Administration and other regulatory agencies may not receive approval in a timely manner or at all, potential delays in the commencement, enrollment and completion of clinical trials and the reporting of data therefrom, uncertainties related to the completeness and accuracy of Biocon data and review by Equillium of Biocon data, and uncertainties related to Equillium’s capital requirements, Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials, including a clinical trial of patients with COVID-19, uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic, uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause, whether the results from clinical trials will validate and support the safety and efficacy of itolizumab, changes in the competitive landscape, reliance on third parties for manufacturing and development efforts and uncertainties having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor ContactChristine Zedelmayer, Chief Operating Officer +1-858-412-5302 ir@equilliumbio.comMedia ContactCammy Duong Canale Communications +1-619-849-5389 cammy@canalecomm.com
- 08/13/2020
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Equillium Reports Second Quarter 2020 Financial Results and Recent Highlights
- LA JOLLA, Calif., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced financial results for the second quarter 2020. “We have made significant progress across a number of fronts since our last update,” said Bruce Steel co-founder and chief executive officer of Equillium. “The positive interim data we recently reported from the Phase 1b portion of our EQUATE clinical trial of itolizumab in patients with acute graft-versus-host-disease (aGVHD), historically a particularly challenging and deadly indication, enhances our confidence in itolizumab as a potential life-saving treatment for these patients. Together with the encouraging data reported by our partner, Biocon Limited (Biocon), demonstrating itolizumab (ALZUMAb™) reduced mortality in patients hospitalized with COVID-19 in their Phase 2 trial conducted in India, we have gained additional and timely early evidence of drug activity across multiple autoimmune and inflammatory conditions, which supports our conviction that itolizumab’s novel immune-modulating mechanism may have promise in addressing a range of severe immuno-inflammatory disorders. We are now positioned for a number of upcoming catalysts, including proceeding with additional cohorts in our EQUATE trial, initiating a global randomized controlled clinical trial in hospitalized patients with COVID-19, and advancing our Phase 1b EQUIP and EQUALISE trials in uncontrolled asthma and lupus nephritis, respectively.”Business Highlights: * Reported positive interim data from EQUATE clinical trial of itolizumab as a first line therapy for patients with aGVHD – 71% of patients treated to date achieved a complete response at Day 29 * Shared encouraging topline results as reported by Biocon from their randomized, controlled open label clinical trial conducted in India showing itolizumab (ALZUMAb) reduced mortality over one month as compared to placebo in patients hospitalized with COVID-19. As a result of the study, Biocon received emergency use approval from the Drugs Controller General of India (DCGI) for itolizumab in the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) * Submitted a pre-investigational new drug (pre-IND) meeting request and supporting briefing package to the U.S. Food and Drug Administration (FDA) to study itolizumab in hospitalized patients with COVID-19 * Engaged prominent advisors Siddhartha Mukherjee, M.D., Ph.D., Pulitzer Prize Award-winning author, and an associate professor of medicine at Columbia University’s Herbert Irving Comprehensive Cancer Center, Ivor S. Douglas, M.D., FRCP (UK) professor of medicine, chief of pulmonary and critical care and medical director, Medical Intensive Care Denver Health Medical Center, and Atul Malhotra, M.D., research chief of pulmonary and critical care medicine at the University of California San Diego School of Medicine to help guide Equillium’s COVID-19 program * Strengthened the balance sheet by raising a total of approximately $17.9 million in gross proceeds subsequent to the end of the second quarter 2020Upcoming Catalysts: * Initiation of a global trial of itolizumab in hospitalized patients with COVID-19 * Advancing ongoing EQUATE, EQUIP and EQUALISE trialsSecond Quarter 2020 Financial ResultsResearch and development (R&D) expenses. Total R&D expenses for the three months ended June 30, 2020 were $3.9 million, compared with $4.3 million for the same period in 2019. The decrease in R&D expenses was primarily the result of lower clinical development expense driven by the higher startup costs incurred for the EQUIP trial in the second quarter of 2019 as well as the pausing of that study during the second quarter of 2020 due to the COVID-19 pandemic. Other contributors to the decrease in R&D expenses included lower consulting and travel expenses, offset by an increase in employee compensation and benefits primarily related to increased headcount.General and administrative (G&A) expenses. Total G&A expenses for the three months ended June 30, 2020 were $2.7 million, compared with $2.2 million for the same period in 2019. The increase in G&A expenses was primarily driven by greater non-cash stock-based compensation expense, offset by decreases in outside legal expenses, salaries, and travel.Net loss. Net loss for the three months ended June 30, 2020 was $6.5 million, or $(0.37) per basic and diluted share, compared with a net loss of $6.1 million, or $(0.35) per basic and diluted share for the same period in 2019.Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling $42.6 million at June 30, 2020, compared to $53.1 million at December 31, 2019.Cash used in operations. Equillium used approximately $5.1 million of cash in its operations during the three months ended June 30, 2020, compared to $6.3M in the prior quarter ended March 31, 2020. About Equillium Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need.Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab has been clinically validated with a favorable safety and tolerability profile based on its approved uses in India. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon. Biocon manufactures EQ001 and ALZUMAb at an FDA-regulated commercial scale facility; both products share the same primary monoclonal antibody sequence, but are manufactured in different cell lines, and EQ001 is available in both intravenous and subcutaneous dosing whereas ALZUMAb is currently available in intravenous dosing only. Biocon has recently reported results from a study of ALZUMAb in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General of India for ALZUMAb for the treatment of CRS in COVID-19 patients with moderate to severe ARDS in India. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic in several indications and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an investigational new drug application for the treatment of COVID-19 patients. For more information, visit www.equilliumbio.com.Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the impact of new advisors to guide the COVID-19 program, the potential benefit of treating COVID-19 patients with itolizumab, planned clinical studies as a result of data reported by Biocon, Equillium’s business strategy, Equillium’s plans and expected timing for developing itolizumab, including the ability to enroll additional cohorts in, and continue to report favorable result from, our EQUATE clinical trial and initiating a clinical trial in patients with COVID-19, the potential benefits of itolizumab, Equillium’s cash runway and the impact of the COVID-19 pandemic. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties pending full review by Equillium of the Biocon dataset and uncertainties related to Equillium’s capital requirements, Equillium’s plans and product development, including the initiation, restarting and completion of clinical trials, including a clinical trial of patients with COVID-19, uncertainties related to the actual impacts and length of such impacts caused by the COVID-19 pandemic, uncertainties caused by the recent restarting of the EQUIP and EQUALISE clinical trials after a pause, whether the results from clinical trials will validate and support the safety and efficacy of itolizumab, having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor Contact Christine Zedelmayer, Chief Operating Officer +1-858-412-5302 ir@equilliumbio.comMedia Contact Cammy Duong Canale Communications +1-619-849-5389 cammy@canalecomm.com Equillium, Inc.
- 08/12/2020
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The Daily Biotech Pulse: Regulatory Setback For Fennec Pharma, Ligand To Buy Pfenex, Inovio Says Phase 2/3 Coronavirus Vaccine Study Starts In September
- Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Aug. 10) * Allovir Inc (NASDAQ: ALVR) * BioLife Solutions Inc (NASDAQ: BLFS) * BioSpecifics Technologies Corp. (NASDAQ: BSTC) (reacted to second-quarter results) * CymaBay Therapeutics Inc (NASDAQ: CBAY) * Eton Pharmaceuticals Inc (NASDAQ: ETON) * Fennec Pharmaceuticals Inc (NASDAQ: FENC) * Fulgent Genetics Inc (NASDAQ: FLGT) * Harvard Bioscience, Inc. (NASDAQ: HBIO) * Inari Medical Inc (NASDAQ: NARI) * Kura Oncology Inc (NASDAQ: KURA) * Omeros Corporation (NASDAQ: OMER) (announced positive results for the study of its lead asset in COVID-19) * Pacira Biosciences Inc (NASDAQ: PCRX) * RedHill Biopharma Ltd (NASDAQ: RDHL) * Rocket Pharmaceuticals Inc (NASDAQ: RCKT) * Seres Therapeutics Inc (NASDAQ: MCRB) (reacted to positive late-stage clinical readout) * Silk Road Medical Inc (NASDAQ: SILK) * Sorrento Therapeutics Inc (NASDAQ: SRNE) * Trevena Inc (NASDAQ: TRVN) (announced FDA nod for pain drug) * Unity Biotechnology Inc (NASDAQ: UBX) * Vaxcyte Inc (NASDAQ: PCVX)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Aug. 10) * Checkmate Pharmaceuticals Inc (NASDAQ: CMPI) (went public Friday) * Freeline Therapeutics Holdings plc ADS (NASDAQ: FRLN) (went public Friday) * Lantern Pharma Inc. (NASDAQ: LTRN) * Nkarta Inc (NASDAQ: NKTX) * Recro Pharma Inc (NASDAQ: REPH) (reacted to second-quarter results)Stocks In Focus Equillium Announces Positive Interim Data For Lead Drug, Requests Pre-IND Meeting For COVID-19 Study Equillium Inc (NASDAQ: EQ) announced positive interim data from the first two cohorts of the Phase 1b open label, dose escalation portion of the EQUATE study of itolizumab in acute graft-versus-host disease. Across the first two dose cohorts, itolizumab has been generally well-tolerated to date, and five of seven patients achieved a complete response by day 29, the company said.Additionally, Equillium said it has submitted a request to the FDA for a pre-IND meeting to review its proposal to initiate a global randomized controlled clinical trial to study itolizumab in hospitalized patients with COVID-19.The stock was trading 21.29% higher premarket Tuesday at $12.19. Clearside's IND Application Approved For Wet AMD Study Clearside Biomedical Inc (NASDAQ: CLSD) said the FDA has accepted its IND application for CLS-AX, enabling initiation of a Phase 1/2a clinical trial of CLS-AX in neovascular age-related macular degeneration patients by the end of 2020.The dose-escalation study will assess the safety and tolerability of single doses of CLS-AX administered through suprachoroidal injection following two or more prior treatments with an intravitreal anti-VEGF agent, according to the company. Separately, the company announced second-quarter results, reporting an increase in license revenue from $45,000 in 2019 to $354,000 in 2020. The net loss per share narrowed from 15 cents to 13 cents, but was wider than the 12-cent-per-share loss expected by analysts.The stock was up 7.26% at $1.92 premarket Tuesday.Innate Pharma Receives French Government Funding For COVID-19 Research Innate Pharma SA (NASDAQ: IPHA) said it has received 6.8 million euros ($8 million) in funding from the French government to support its COVID-19 R&D activities.The company said it expects the funding to help cover the development of the COVID-19 activities it began in March 2020, including the EXPLORE COVID-19 translational research study and its two Phase 2 clinical trials, FORCE and ImmunONCOVID-20.Fennec Handed Complete Response Letter For Drug To Treat Chemotherapy-Induced Ototoxicity Fennec Pharma said it received a complete response letter Monday from the FDA regarding its NDA for Pedmark, a unique formulation of sodium thiosulfate, for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic solid tumors.The stock was plunging 28.42% premarket to $7.28.See also: The Week Ahead In Biotech: Bausch Health, Fennec Pharma FDA Decisions And Smid-cap Earning Catalyst's Firdapse Flunks Late-Stage Study In Neuromuscular Disease Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) said the top-line results from its Phase 3 study for Firdapse in anti-MuSK antibody positive myasthenia gravis patients did not replicate the robust positive results that were observed in the 2017 proof-of-concept study. The study did not meet the primary or secondary endpoints.The company also reported second-quarter results, showing a modest increase in revenue but a decline in EPS, which beat the consensus estimate by a penny.The stock was down 11.14% at $3.79 premarket. Ligand To Buy Pfenex For Up To $516M Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and Pfenex Inc (NYSE: PFNX) announced the signing of a definitive agreement for Ligand to acquire all outstanding shares of Pfenex for $12 per share in cash or $438 million in equity value on a fully diluted basis.View more earnings on IBBAdditionally, Ligand will pay $2 per share or $78 million as a contingent value right in the event a predefined regulatory milestone is achieved by Dec. 31, 2021, for a total transaction value of up to $516 million. The transaction is expected to close in the fourth quarter.In premarket trading, Pfenex shares were jumping 63.45% to $12.52.Mesoblast Slumps As FDA Raises Questions Over Stem Cell Efficacy In Graft-Versus-Host Disease Shares of stem cell therapy company Mesoblast limited (NASDAQ: MESO) moved to the downside after FDA staffers expressed doubts over the adequacy of evidence for the efficacy of the company's remestemcel-L for treating acute graft-versus-host disease in children.The comments came in a briefing document released ahead of an Adcom meeting. The FDA's Oncologic Drugs Advisory Committee is scheduled to meet Thursday to discuss the BLA submitted by the company.The stock was down 25.66% at $12.95 premarket Tuesday.Inovio To Commence Late-Stage Coronavirus Vaccine Study In September, Q2 Results Trail Estimates Inovio Pharmaceuticals Inc (NASDAQ: INO) said it looks forward to starting a Phase 2/3 coronavirus vaccine study in the U.S. in September.The company reported second-quarter revenue of $267,187 in 2020 compared to $135,673 in 2019. The loss per share widened from 30 cents to 83 cents. Analysts estimated a loss of 17 cents per share on revenue of $2.61 million.The stock was down 11.01% at $16.90 premarket Tuesday. Earnings ICU Medical Inc's (NASDAQ: ICUI) second-quarter revenue fell from $312.3 million in 2019 to $303.4 million, and adjusted EPS fell from $1.99 to $1.65. The results, however, exceeded expectations.Separately, the company announced a long-term agreement with Grifols SA - ADR ADR Class B (NASDAQ: GRFS) to distribute a full line of non-PVC/non-DEHP IV containers for 0.9% sodium chloride injections in the U.S. Omeros said its second-quarter revenue fell from $26.8 million in 2019 to $13.5 million in 2020, with the downside blamed on the postponement of cataract procedures by ASCs and hospitals due to COVID-19.The net loss per share narrowed from 61 cents to 29 cents. The revenue missed estimates and the net loss per share was wider than the consensus estimate.Separately, the company said it has commenced concurrent underwritten public offerings of $125 million shares of its common stock and $200 million in an aggregate principal amount of convertible senior notes due 2026.The stock was down 7.83% at $19.65 premarket Tuesday.Offerings PDS Biotechnology Corp (NASDAQ: PDSB) said it intends to offer shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by the company.The stock was down 20.92% at $3.10 premarket Tuesday.On The Radar PDUFA Dates The FDA's decision on label expansion for Roche Holdings AG's Basel ADR Common Stock (OTC: RHHBY) Xolair for the treatment of nasal polyps could arrive, as the company is 10 months out from the submission of the sBLA.Earnings * BioNTech SE - ADR (NASDAQ: BNTX) (before the market open) * STRATA Skin Sciences Inc (NASDAQ: SSKN) (before the market open) * Surface Oncology Inc (NASDAQ: SURF) (before the market open) * Prevail Therapeutics Inc (NASDAQ: PRVL) (before the market open) * Generation Bio Co (NASDAQ: GBIO) (before the market open) * Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open) * Affimed NV (NASDAQ: AFMD) (before the market open) * Burning Rock Biotech Ltd (NASDAQ: BNR) (before the market open) * Gamida Cell Ltd (NASDAQ: GMDA) (before the market open) * 10X Genomics Inc (NASDAQ: TXG) (after the market close) * Agile Therapeutics Inc (NASDAQ: AGRX) (after the market close) * Aethlon Medical, Inc. (NASDAQ: AEMD) (after the market close) * T2 Biosystems Inc (NASDAQ: TTOO) (after the market close) * Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the market close) * DiaMedica Therapeutics Inc (NASDAQ: DMAC) (after the market close) * HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the market close) * Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) (after the market close) * Shockwave Medical Inc (NASDAQ: SWAV) (after the market close) * RA Medical Systems Inc (NYSE: RMED) (after the market close) * Inari Medical (after the market close)Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates See more from Benzinga * The Daily Biotech Pulse: Novavax Vaccine Deals, Trevena Awaits FDA Decision, 2 IPOs * The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Bristol-Myers Squibb Earnings, Acutus Medical IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
- 08/11/2020
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What Type Of Shareholders Make Up Equillium, Inc.'s (NASDAQ:EQ) Share Registry?
- If you want to know who really controls Equillium, Inc. (NASDAQ:EQ), then you'll have to look at the makeup of its...
- 08/11/2020
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What Type Of Shareholders Own The Most Number of Equillium, Inc. (NASDAQ:EQ) Shares?
- A look at the shareholders of Equillium, Inc. (NASDAQ:EQ) can tell us which group is most powerful. Institutions will...
- 08/11/2020
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Equillium Announces Positive Interim Data with Itolizumab in Acute GVHD Study
- Complete response observed in five of seven patients in first two dose cohorts COVID-19 Pre-IND meeting request and briefing package submitted to the FDALA JOLLA, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced positive interim data from the first two cohorts of the Phase 1b open label, dose escalation portion of the EQUATE study of itolizumab in acute graft-versus-host disease (aGVHD). Across the first two dose cohorts itolizumab has been generally well tolerated to date, and five of seven patients achieved a complete response (CR) by Day 29. Additionally, Equillium has submitted a request to the U.S. Food and Drug Administration (FDA) for a Pre-Investigational New Drug (Pre-IND) meeting to review its proposal to initiate a global randomized controlled clinical trial to study itolizumab in hospitalized patients with COVID-19.aGVHD The EQUATE study is evaluating itolizumab in severe aGVHD patients – Grades III and IV – as a first-line treatment concomitant with standard of care, which is typically comprised of high dose corticosteroids, as no other therapeutics are currently approved for this indication. Across the first two dose cohorts of the Phase 1b open-label portion of the study 71% of patients achieved a CR by Day 29. In the first cohort at the 0.4 mg/kg dose, two of four patients achieved a CR, resulting in a CR and overall response (OR) rate of 50%. In the second cohort at the 0.8 mg/kg dose, all three patients achieved a CR, resulting in a CR and OR rate of 100%. Additionally, these CRs occurred early during itolizumab treatment course, with all patients achieving a CR within the first 15 days of treatment. Itolizumab has been well tolerated to date and adverse events have been consistent with those expected in this severely ill aGVHD patient population. Based on a thorough review of the available safety data across both cohorts, the independent data safety monitoring committee has recommended to proceed with dose escalation in the third cohort (1.6mg/kg) of the EQUATE study as planned.“We are very encouraged by the early response rates observed in the first two cohorts of aGVHD patients dosed with itolizumab, particularly since the individuals enrolled in the EQUATE study had Grade III or IV disease, representing the most gravely ill patients,” said Krishna Polu, M.D., chief medical officer of Equillium. “Achieving clinical activity in a majority of these initial patients treated with itolizumab, with a time to the initial response within 15 days, is promising given the rapid progression and high acuity of aGVHD, where the time to an effective response may be critical. We believe these data, along with the encouraging results reported by Biocon from its recent COVID-19 study, continue to support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing a range of severe immuno-inflammatory disorders. We look forward to continuing to advance our development programs as rapidly as possible.”The initial data from the first two dose cohorts of the EQUATE study are summarized in the table below.Itolizumab aGHVD (Grades III & IV) Study: Complete and Overall Response Rate at Day 29 CohortItolizumab Dose (mg/kg)Number of PatientsNumber with Complete ResponseComplete Response Rate % All / EvaluableNumber with Overall ResponseOverall Response Rate % All / Evaluable 10.44*250% / 66%250% / 66% 20.833100% / 100%3100% / 100% 1 & 2see above7571% / 83%571% / 83% * Per the EQUATE protocol, patients must receive two doses to be considered evaluable for dose limiting toxicities at Day 29. One patient in cohort 1 experienced aGVHD progression after the first dose of itolizumab, received rescue therapy at Day 7, and consequently was discontinued and replaced in the EQUATE study; the patient further progressed after receiving rescue therapy and died on Day 137. One patient in cohort 1 experienced mild/moderate infusion reaction associated with itolizumab treatment. “These early response data are very promising as patients with severe aGVHD typically have a lower response to steroids,” said principal investigator of the EQUATE study, John Koreth, MBBS DPhil., director of translational research, stem cell transplantation, Dana-Farber Cancer Institute. “I am optimistic about the future of itolizumab as a potential treatment for aGVHD patients in need of effective and well-tolerated therapies. With the increase in the number of stem cell transplants to address aggressive/advanced hematologic malignancies, there continues to be significant need for new treatment options for GVHD, particularly for the patients at highest risk of mortality.”COVID-19 In July 2020, Equillium announced that its partner, Biocon Limited (Biocon), reported a randomized, controlled, open label clinical trial conducted in India demonstrated that itolizumab (ALZUMAbÔ) significantly reduced mortality over one month as compared to placebo in patients hospitalized with COVID-19, and that the Drugs Controller General of India granted emergency use of ALZUMAb for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.Based on the encouraging results reported by Biocon in its COVID-19 study, the novel and differentiated T cell modulating mechanism of action of itolizumab, and the fact that no targeted immuno-modulating therapies are currently approved to treat COVID-19 patients, Equillium continues to advance its plan to develop itolizumab to treat hospitalized patients with COVID-19. In accordance with the FDA’s industry guidance for COVID-19 biological products, Equillium has submitted a Pre-IND meeting request and supporting briefing package to FDA to review its proposal to conduct a global randomized placebo-controlled clinical trial in hospitalized COVID-19 patients. Equillium and Biocon intend to work closely together in the further development of itolizumab in COVID-19 patients and, importantly, planning scale-up of manufacturing to support access to treatment for the greatest possible number of patients worldwide. A summary of Biocon’s completed study results has been submitted to the ClinicalTrials.gov database and is available on Biocon’s website.About Graft-Versus-Host Disease GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system recognizing and attacking the recipient’s body. Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea and jaundice, as well as eye dryness and irritation.GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and the risk of GVHD limits the number and type of patients receiving HSCT. GVHD results in very high morbidity and mortality, with five-year survival of approximately 53% in patients who respond to steroid treatment and mortality as high as 95% in patients who do not respond to steroids. In the first-line aGVHD setting, published literature (MacMillan et al., 2015) describes background response rates to high-dose steroid administration in standard risk patients, e.g. Grades II thru IV, of 69% OR and 48% CR, whereas in high-risk patients, e.g. Grades III thru IV, response rates observed were 43% OR and 27% CR. About the EQUATE Study The EQUATE study is a Phase 1b/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of itolizumab for first-line treatment in patients who present with aGVHD (NCT 03763318). The Phase 1b part of the study is an open-label dose escalation study in adult patients who present with high-risk aGVHD (Grades III and IV) and typically respond poorly to steroids. The Phase 1b data will inform selection of the dose to be used in the next phase of development for the program. About Equillium Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need.Equillium’s initial product candidate, itolizumab (EQ001), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab has been clinically validated with a favorable safety and tolerability profile based on its approved uses in India. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon. Biocon manufactures EQ001 and ALZUMAb at an FDA-regulated commercial scale facility; both products share the same primary monoclonal antibody sequence, but are manufactured in different cell lines, and EQ001 is available in both intravenous and subcutaneous dosing whereas ALZUMAb is currently available in intravenous dosing only. Biocon has recently reported results from a study of ALZUMAb in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General of India for ALZUMAb for the treatment of CRS in COVID-19 patients with moderate to severe ARDS in India. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic in several indications and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an investigational new drug application for the treatment of COVID-19 patients. For more information, visit www.equilliumbio.com.
- 08/10/2020
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With Biotech Stocks, Investors Love the Thrill of the Chase
- Individual investors are placing their bets on biotech companies pursuing coronavirus advances. Some invest for fun and profit, while others want to be a part of a historic breakthrough.
- 08/05/2020
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Equillium to Present at BTIG Virtual Biotechnology Conference 2020
- LA JOLLA, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders, today announced that Bruce Steel, Equillium’s chief executive officer and Krishna Polu, M.D., Equillium’s chief medical officer, will participate in a fireside discussion at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11, 2020. Date: Tuesday, August 11, 2020 Time: 3:30 PM Eastern Time | 12:30 PM Pacific Time Location: Virtual Webcast Live webcast of the presentation will be available under the “Investors” section of the Company’s website at https://ir.equilliumbio.com/. Replays will be available for 30 days following each webcast. About EquilliumEquillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need.Equillium’s initial product candidate, itolizumab, is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Biocon has recently reported results from a study of itolizumab in COVID-19 patients in India, and has subsequently received emergency use authorization from the Drugs Controller General of India for itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India. Equillium believes that itolizumab has the potential to be a best-in-class disease modifying therapeutic and is developing itolizumab in multiple severe immuno-inflammatory disorders – acute graft-versus-host disease, uncontrolled asthma, and lupus nephritis – and is planning to submit an investigational new drug application for the treatment of COVID-19 patients. For more information, visit www.equilliumbio.com.Investor ContactChristine Zedelmayer, Chief Operating Officer +1-858-412-5302 ir@equilliumbio.comMedia Contact Cammy Duong Canale Communications +1-619-849-5389 cammy@canalecomm.com
- 07/30/2020
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Southern California Bancorp Announces Results for the Second Quarter 2020
- Southern California Bancorp (the “Company”) (OTC Pink: BCAL), the holding company for Bank of Southern California, N.A. (the “Bank”) today reported re
- 07/27/2020
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Zacks: Analysts Anticipate Equillium (NYSE:EQ) to Announce -$0.44 Earnings Per Share
- Wall Street analysts expect Equillium (NYSE:EQ) to announce ($0.44) earnings per share for the current quarter, according to Zacks Investment Research. Zero analysts have issued estimates for Equillium’s earnings, with the highest EPS estimate coming in at ($0.35) and the lowest estimate coming in at ($0.50). Equillium reported earnings per share of ($0.35) during the […]
- 07/16/2020
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20 Healthcare Stocks Moving In Thursday's Pre-Market Session
- Gainers
• AC Immune, Inc. (NASDAQ:ACIU) shares rose 88.45% to $13.55 during Thursday's pre-market session.
• Nabriva Therapeutics, Inc. (NASDAQ:NBRV) stock increased...
- 07/16/2020
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Equillium COVID-19 Data, And Other News: The Good, Bad And Ugly Of Biopharma
- Equillium reports positive data for COVID-19 drug trial. CytoDyn's BLA filing is rejected.
- 07/15/2020
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Artelo Biosciences Reports Q3 Results, Talks Patent For Cocrystal CBD
- Artelo Biosciences (NASDAQ: ARTL) announced its third-quarter results as of May 31.
The La Jolla, California-based company reported a net loss of $951,191,...
- 07/15/2020
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Equillium (EQ) Stock Price Target Gets a Big Boost; Here’s What You Need to Know
- Headline grabbing biotechs are far from a rare sight in 2020. Nevertheless, when a little-known micro-cap pops by 730% in a single trading session, avid market followers are likely to take notice.And so to Equillium (EQ), the aforementioned little known biotech, whose shares blasted off on Monday.The rally began following the announcement that the Drugs Controller General of India – India’s equivalent of the FDA - granted Equillium's partner Biocon emergency approval for itolizumab, a treatment of cytokine release syndrome (CRS) in COVID-19 patients with acute respiratory distress syndrome (ARDS). The approval came following a 30-patient proof-of-concept trial in which the drug reduced mortality in hospitalized COVID-19 patients (all patients given the drug survived).The drug is currently being developed as a treatment for various autoimmune and inflammatory diseases. However, Equillium now plans to file an investigational new drug (IND) application so it can proceed with a clinical trial of itolizumab in COVID-19 patients in the US.H.C. Wainwright analyst Ram Selvaraju believes progress could be fast once the wheels are set in motion.“In our view,” said the 5-star analyst, “itolizumab could be developed rapidly using a similar trial design in a larger patient group—perhaps no more than 200-400 subjects—with a randomized, double-blinded, controlled approach. Such a trial program in the U.S. could be accomplished involving only 10-12 centers and might cost under $10M to execute. If started in the next several weeks, we believe such a trial could yield results in early 4Q20 and facilitate either accelerated approval or Emergency Use Authorization from the FDA before year-end.”Selvaraju estimates that the “penetration rate” in the U.S. for the treatment won’t exceed 3.5%, as the patients eligible to receive itolizumab - those with specific types of immunological and respiratory complications - make up less than 15% of all COVID-19-infected patients.The analyst reckons the treatment will sell for approximately $1,750 per course, and could notch “potential peak sales of over $500 million in the U.S. market by 2022,” after which sales are expected to decline as the pandemic gradually retreats.To this end, Selvaraju boosts his price target on EQ to $24 (from $14), which implies about 70% upside from current levels. (To watch Selvaraju’s track record, click here)Only one other analyst has posted an EQ review over the last 3 months, also recommending a Buy. (See Equillium 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.
- 07/14/2020
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Equillium Gains From Positive Results on Coronavirus Drug
- Equillium (EQ) soars on positive results on pipeline candidate, itolizumab, for COVID-19.
- 07/14/2020
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EQUILLIUM : CLINICAL TRIAL SHOWS ITOLIZUMAB REDUCES MORTALITY IN PATIENTS HOSPITALIZED WITH COVID-19 | MarketScreener
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Vaccine Makers BioNTech, Moderna, And Novavax Set To Run Higher
- Stocks Analysis by Harry Boxer covering: KB Home, Vaxart Inc, Novavax Inc, Altimmune Inc. Read Harry Boxer's latest article on Investing.com
- 07/14/2020
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Equillium Explodes 260% On Positive Covid-19 Results; India Approval
- Shares in biotech Equillium (EQ) have almost tripled in Monday’s pre-market trading after the company announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.Equillium is currently developing itolizumab to treat severe autoimmune and inflammatory disorders. The stock is currently trading up 260% in the pre-market.Biocon also announced that the Drugs Controller General of India (DCGI) has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.Based on the encouraging topline results and DCGI approval, Equillium revealed that it is now planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month.As reported by Biocon: * In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered * The mortality benefit observed in the itolizumab arm was statistically significant * Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, CEO of Equillium.Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of pathogenic T cells that release pro-inflammatory cytokines in a range of autoimmune and inflammatory diseases. Equillium acquired rights to develop and commercialize itolizumab in the U.S., Canada, Australia and New Zealand through an exclusive collaboration and license agreement with Biocon.Equillium is currently evaluating itolizumab under two open U.S. INDs for the treatment of acute graft-versus-host disease and lupus nephritis, as well as conducting a clinical study in uncontrolled asthma in Australia and New Zealand.In March due to the emerging COVID-19 pandemic, Equillium announced that it was pausing enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Equillium has now announced that patient enrollment in both these studies has resumed.Two analysts have recently published buy ratings on EQ. That’s with an average price target of $12. Stifel Nicolaus analyst Derek Archila reiterated his buy rating on the stock following the latest news.“We note the trial in hospitalized COVID-19 patients was small (n=30), open-label and on top of standard of care, and little data were shared but according the Biocon/EQ press releases, the itolizumab arm did demonstrate a statistically significant benefit on mortality at one-month (the primary endpoint)” he told investors.The current literature suggests approximately ~8% of COVID-19 patients develop ARDS and if itolizumab were to be priced in line with Gilead’s (GILD) remdesivir (~$2,500-$3,000 per course) this could be a meaningful market opportunity for EQ, Archila added. (See EQ stock analysis on TipRanks).Related News: Australia Provisionally Approves Gilead’s Covid-19 Treatment Gilead Reveals Covid-19 Treatment Remdesivir Reduces Mortality Risk Moderna Inks Deal With Rovi To Supply Potential Covid-19 Vaccine Outside US More recent articles from Smarter Analyst: * Disney World Reopens To Small Numbers, Analyst Optimistic On Outlook * Alibaba Co-Founder Jack Ma Reduces Stake To 4.8% * South Korea: 1 in 3 Covid-19 Patients Improved With Gilead’s Remdesivir * Amgen Pours A Further $421M Into China’s BeiGene
- 07/13/2020
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Clinical Trial Shows Itolizumab Reduces Mortality in Patients Hospitalized with COVID-19
- Equillium shares topline results of patients treated with itolizumab in clinical trial conducted in India by partner Biocon Biocon has received emergency use approval from.
- 07/13/2020
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U.S. stocks mixed at close of trade; Dow Jones Industrial Average up 0.04%
- U.S. stocks mixed at close of trade; Dow Jones Industrial Average up 0.04%
- 07/13/2020
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-$0.43 Earnings Per Share Expected for Equillium (NYSE:EQ) This Quarter
- Analysts expect Equillium (NYSE:EQ) to post earnings per share (EPS) of ($0.43) for the current quarter, according to Zacks Investment Research. Zero analysts have made estimates for Equillium’s earnings. The lowest EPS estimate is ($0.50) and the highest is ($0.35). Equillium posted earnings of ($0.35) per share during the same quarter last year, which suggests […]
- 06/24/2020
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47 Public Companies to present at the Summer Virtual Investor Summit on June 9th-12th
- NEW YORK, NY / ACCESSWIRE / June 3, 2020 / The Virtual Summer Summit will take place on June 9 th -12 th , connecting 47 presenting small and microcap companies with distinguished investors from around ...
- 06/03/2020
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Equillium to Present at Jefferies Virtual Healthcare Conference
- LA JOLLA, Calif., May 21, 2020 -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products.
- 05/21/2020
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Equillium Reports First Quarter 2020 Financial Results
- LA JOLLA, Calif., May 13, 2020 -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to.
- 05/13/2020
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Equillium to Present at 2020 RBC Capital Markets Virtual Global Healthcare Conference
- LA JOLLA, Calif., May 07, 2020 -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products.
- 05/07/2020
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ADMA Biologics, Inc. (ADMA) CEO Adam Grossman on Q1 2020 Results - Earnings Call Transcript
- Start Time: 16:30 End Time: 17:13 ADMA Biologics, Inc. (NASDAQ:ADMA) Q1 2020 Earnings Conference Call May 06, 2020, 16:30 PM ET Company Participants Adam Grossm
- 05/07/2020
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6 Stock Charts To Watch: AUDC, DVAX, INMD, QTNT, RDHL, VKTX
- Stocks Analysis by Harry Boxer covering: Alphabet Inc Class A, Bed Bath & Beyond Inc, Crude Oil WTI Futures, AudioCodes Ltd. Read Harry Boxer's latest article on Investing.com
- 04/28/2020
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Equillium Announces Common Stock Purchase Agreement for up to $15 Million with Lincoln Park Capital
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced it has entered into a common stock purchase agreement for up to $15 million with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor. Under the terms of the purchase agreement, and once a registration statement relating to the transaction has been declared effective, Equillium will have the right at its sole discretion, but not the obligation, to sell to LPC up to $15 million worth of shares of its common stock over the 36-month term of the agreement.
- 03/30/2020
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Equillium Continues Graft-Versus-Host Disease Trial, Pauses 2 Others
- Equillium has halted two clinical trials of its lead drug candidate out of an “abundance of caution” related to the coronavirus outbreak but continues to
- 03/27/2020
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H.C. Wainwright Keeps Their Buy Rating on Equillium (EQ)
- H.C. Wainwright analyst
Ram Selvaraju
reiterated a
Buy
rating on Equillium (
EQ
–
Research Report
) today and set a price target of
$14.00
. The company’s shares closed last Monday at $2.74, close to its 52-week low of $2.20.
According to
TipRanks.co
- 03/27/2020
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Equillium Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update
- EQUIP and EQUALISE Studies to be Paused in Response to the COVID-19 Pandemic Company Reaffirms Guidance to Report Initial Data from the EQUATE Trial in Acute GVHD in 2H 2020.
- 03/26/2020
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The Daily Biotech Pulse: T2 Biosystems Licenses COVID-19 Test, Immuron CEO Steps Down
- 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 March 24) * BELLUS Health Inc (NASDAQ: BLU) * Global Cord Blood Corp (NYSE: CO) * Thermogenesis Holdings Inc (NASDAQ: THMO)(reacted to its fourth-quarter
- 03/25/2020
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Investors Shaken by Coronavirus Sow Seeds of M&A, Financing Slowdown
- The coronavirus pandemic is narrowing the avenues open to biotechs for financing their endeavors, according to some industry veterans. “I think that fear
- 03/23/2020
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Equillium Strengthens Leadership Team with Key Appointments
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced the appointment of Maple Fung, M.D., as vice president of clinical development and Matthew Ritter, Ph.D
- 02/27/2020
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Equillium to Present at 9th Annual SVB Leerink Global Healthcare Conference
- LA JOLLA, Calif., Feb. 13, 2020 -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products.
- 02/13/2020
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Equillium to Present Translational Preclinical Data Demonstrating Increased Survival and Decreased Disease Severity in Models of Graft-Versus-Host Disease Treated with Itolizumab at the Transplantation & Cellular Therapy Meetings of ASTCT & CIBMTR
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced that translational data supporting the potential of itolizumab in the treatment of graft-versus-host disease (GVHD) will be presented at the Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held February 19-23, 2020 at the World Center Marriott in Orlando, Florida. The research, conducted in mouse models of human disease, demonstrates that blockade of the CD6-ALCAM pathway with anti-CD6 antibodies reduces incidence and severity of both GVHD and gastro-intestinal (GI) inflammation.
- 01/29/2020
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Will Equillium Continue to Surge Higher?
- As of late, it has definitely been a great time to be an investor in Equillium.
- 01/28/2020
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Equillium Sees Hammer Chart Pattern: Time to Buy?
- Equillium has been struggling lately, but the selling pressure may be coming to an end soon.
- 01/09/2020
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Can The Uptrend Continue for Equillium?
- As of late, it has definitely been a great time to be an investor Equillium
- 01/03/2020
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Hedge Funds Are Dumping Equillium, Inc. (EQ)
- We are still in an overall bull market and many stocks that smart money investors were piling into surged through the end of November. Among them, Facebook and Microsoft ranked among the top 3 picks and these stocks gained 54% and 51% respectively. Hedge funds' top 3 stock picks returned 41.7% this year and beat […]
- 12/22/2019
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Equillium & Biocon Expand Exclusive Licensing Agreement for Itolizumab to Include Australia and New Zealand
- Equillium Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, and Biocon Ltd (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceuticals company, today announced that they have expanded their collaboration and license agreement for itolizumab to grant Equillium exclusive rights for developing and commercializing itolizumab in Australia and New Zealand. Equillium had originally secured exclusive rights to develop and commercialize Biocon’s novel biologic, itolizumab, for the U.S. and Canada markets, in May 2017.
- 12/12/2019
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The Daily Biotech Pulse: ASH Meeting Wraps, Fast Track Designation For Equillium, Pfizer To Buy $3M In ContraFect Shares
- The following are top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs Dec. 9.) Acceleron Pharma Inc (NASDAQ: XLRN ) Aimmune Therapeutics ...
- 12/10/2019
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Equillium Granted U.S. FDA Fast Track Designation for Itolizumab for the Treatment of Lupus Nephritis
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for itolizumab for the treatment of lupus nephritis. Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis in September 2019. The FDA’s Fast Track program is designed to facilitate the development of new treatments for serious or life-threatening conditions for which there is a significant unmet medical need.
- 12/09/2019
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Equillium Shares March Higher, Can It Continue?
- As of late, it has definitely been a great time to be an investor Equillium.
- 12/09/2019
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Equillium to Present Translational Data on Itolizumab for Acute Graft-Versus-Host Disease at 61st American Society of Hematology (ASH) Annual Meeting and Exposition
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced that data supporting the role of the CD6-ALCAM pathway as a relevant target for patients with acute graft-versus-host disease (aGVHD) along with details of the EQUATE Phase 1b/2 trial design will be presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition being held from December 7-10, 2019 in Orlando, Florida. Data demonstrating itolizumab efficiently inhibits T cell responses in samples taken from patients with aGVHD received the ASH Abstract Achievement Award. Additionally, data supporting itolizumab as a potential systemic treatment that can modulate pathogenic T effector cell activity in an in vivo model of disease has been published online-only in Blood, the journal of ASH.
- 11/26/2019
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Equillium Featured in Panel Discussion at Capital Markets Day for Kidney Health
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced that Krishna R. Polu, M.D., chief medical officer, will participate in a panel discussing “New Innovations in Drug Therapy” as part of the Kidney Capital Markets Day hosted by the American Society of Nephrology (ASN) and RenalytixAI on Tuesday, November 19, 2019 in London, England. “We applaud the ASN for spearheading efforts to gather senior officials from leading health agencies, investors and medical technology and life sciences companies to increase visibility in innovation and investments in all aspects of kidney diseases,” said Dr. Polu.
- 11/15/2019
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Equillium Announces Leadership Updates
- Equillium, Inc. (EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, today announced the appointment of Bruce Steel, the company’s current president and chief business officer, as president and chief executive officer effective January 1, 2020.
- 11/12/2019
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Equillium Reports Third Quarter 2019 Financial Results and Recent Highlights
- LA JOLLA, Calif., Nov. 12, 2019 -- Equillium, Inc. (Nasdaq: EQ), a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe.
- 11/12/2019
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Equillium to Present at Investor Conferences in November 2019
- LA JOLLA, Calif., Nov. 07, 2019 -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to.
- 11/07/2019
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