European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech's proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. This is believed to be the first marketing authorization application filing announced globally for a biosimilar candidate to Simponi. The approvals process is anticipated to be completed in the fourth quarter of 2025. "This is a welcome milestone for us, our partners, patients and caregivers, as we take one step closer to being able to offer access to biosimilar Simponi®," said Joseph McClellan, Chief Scientific Officer of Alvotech. “We believe having the capability and know-how inhouse to utilize a host cell line and process also used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi®." “The EMA's acceptance of the application for AVT05 represents a significant step forward in expanding treatment options for patients with chronic inflammatory diseases across Europe,” said Nick Warwick, Chief Medical Officer of Advanz Pharma. “We are committed to improving patient access to high-quality biologic medicines.” Alvotech and Advanz Pharma first announced in February 2023 that the companies had entered into a commercialization agreement, for AVT23, a proposed biosimilar to Xolair® (omalizumab). In May this year, the partners announced an expansion of the strategic partnership, to include five additional biosimilar candidates being developed by Alvotech, AVT05, AVT16 a proposed biosimilar to Entyvio® (vedolizumab) and three additional early-stage biosimilar candidates which remain undisclosed. In April 2024 Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and Simponi® in patients with moderate to severe rheumatoid arthritis. In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants.
- 11/04/2024
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Alvotech Meeting Investors and Presenting at the Jefferies 2024 London Healthcare Conference on November 19–20, 2024
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference, November 19-20, 2024. Members of the management team will host one-on-one meetings on both days. Alvotech will be presenting at the conference on Tuesday, November 19, 2024 at 9:00-9:25 am GMT.
- 10/25/2024
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Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab)
- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. This approval paves the way for SELARSDI to further align its label with the indications of the reference product Stelara® (ustekinumab) in the U.S. at launch, which is expected in the first quarter of 2025.
- 10/22/2024
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European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
- 10/10/2024
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European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
- REYKJAVIK, Iceland, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
- 10/10/2024
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Alvotech (ALVO) Shares Up 3.77% on Oct 2
- Shares of Alvotech (ALVO, Financial) surged 3.77% in mid-day trading on Oct 2. The stock reached an intraday high of $12.50, before settling at $12.40, up from its previous close of $11.95.
- 10/02/2024
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Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio.
- 09/25/2024
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Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
- REYKJAVIK, Iceland, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The objective of the study is to demonstrate comparative efficacy, safety, and immunogenicity of AVT16 and Entyvio, in male and female participants 18-80 years old with moderate to severe active Ulcerative Colitis. Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for a biosimilar candidate to Entyvio.
- 09/25/2024
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Alvotech to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35 GMT).
- 08/26/2024
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Alvotech to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference
- REYKJAVIK, Iceland, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference in New York. Members of the management team will hold an in-person fireside chat on September 5, 2024, starting at 5:35 pm EDT (21:35 GMT).
- 08/26/2024
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Alvotech: Steady Progress Offers A Good Chance Of Upside
- Alvotech offers exposure to the biosimilar industry at a cheaper price compared to other generic drug manufacturers. The company has successfully commercialized two biosimilar drugs - Stelara and Humira - with more in the pipeline. The company announced Q2 earnings on August 16th, with record revenues of $235.6 million and quarterly EBITDA of $102 million.
- 08/26/2024
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Alvotech (ALVO) Q2 2024 Earnings Call Transcript
- Alvotech (NASDAQ:ALVO ) Q2 2024 Earnings Conference Call August 16, 2024 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director, Investor Relations and Global Communications Robert Wessman - Founder, Chairman and Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Conference Call Participants Carl Byrnes - Northland Capital Markets Kirsty Ross Stewart - Citi Operator Good day, and thank you for standing by. Welcome to the Alvotech's Q2 2024 Earnings Conference Call.
- 08/16/2024
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Alvotech Reports Record Revenues and Adjusted EBITDA for the Second Quarter and First Six Months of 2024
- REYKJAVIK, Iceland, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first six months of 2024 and provided a summary of recent corporate highlights.
- 08/15/2024
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European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025.
- 08/15/2024
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Alvotech to Report Financial Results for the First Half of 2024 on August 15, 2024, and Host Conference Call on August 16, 2024, at 8:00 am ET
- REYKJAVIK, Iceland, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Friday August 16, 2024, at 8:00 am EDT (12 noon GMT).
- 08/01/2024
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Alvotech to Report Financial Results for the First Half of 2024 on August 15, 2024, and Host Conference Call on August 16, 2024, at 8:00 am ET
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, will release financial results for first half of the year ended June 30, 2024, after U.S. markets close on Thursday, August 15, 2024, and will conduct a conference call with analysts to present the financial results and recent business highlights on Friday August 16, 2024, at 8:00 am EDT (12 noon GMT).
- 08/01/2024
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STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe
- STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe Launch of European-made Uzpruvo in Europe comes immediately upon expiry of exclusivity rights for the molecule used to treat certain conditions in gastroenterology1, dermatology and rheumatology Creates competition at earliest opportunity, enabling straightforward switching to broaden patient access and control costs in a growing market, with accessible indications currently estimated at approximately €2.4 billion Ustekinumab is the second immunology biosimilar brought to market through the partnership between STADA and Alvotech, following the 2022 launch of the Hukyndra high-concentration adalimumab brand Bad Vilbel, Germany and Reykjavik, Iceland – 22 July 2024 –STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry.
- 07/22/2024
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STADA and Alvotech launch Uzpruvo, the first approved ustekinumab biosimilar to Stelara, across Europe
- Launch of European-made Uzpruvo in Europe comes immediately upon expiry of exclusivity rights for the molecule used to treat certain conditions in gastroenterology1, dermatology and rheumatology Creates competition at earliest opportunity, enabling straightforward switching to broaden patient access and control costs in a growing market, with accessible indications currently estimated at approximately €2.4 billion Ustekinumab is the second immunology biosimilar brought to market through the partnership between STADA and Alvotech, following the 2022 launch of the Hukyndra high-concentration adalimumab brand BAD VILBEL, Germany and REYKJAVIK, Iceland, July 22, 2024 (GLOBE NEWSWIRE) -- STADA and Alvotech have launched Uzpruvo®, the first approved biosimilar to Stelara® in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry.
- 07/22/2024
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Alvotech Announces Closing of Private Debt Financing
- REYKJAVIK, Iceland, July 11, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the closing of its previously announced senior secured first lien term loan facility (the “Facility”). The closing has allowed Alvotech to refinance outstanding debt obligations, reduce the cost of capital and improve its overall debt maturity profile.
- 07/11/2024
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Alvotech Issues New Shares to Holders of Convertible Bonds
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today issued new shares to holders of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, with maturity on December 20, 2025 (the “Convertible Bonds”).
- 07/01/2024
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Alvotech Announces Record Preliminary Results for Revenues and EBITDA for the Second Quarter of 2024
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced certain preliminary, unaudited key financial information for the second quarter and six months ended June 30, 2024, as follows:
- 07/01/2024
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Alvotech Receives Conversion Notices for Majority of Convertible Bonds
- REYKJAVIK, Iceland , June 26, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that holders of the majority of subordinated convertible bonds, originally issued by Alvotech on November 16, 2022, and December 20, 2022, respectively, with maturity on December 20, 2025 (the “Convertible Bonds”) have elected to convert the principal and accrued interest into ordinary shares of Alvotech at the fixed conversion price of US$10.00 per share on the last scheduled conversion date prior to maturity, which is July 1, 2024 (the “Conversion Date”).
- 06/26/2024
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Are Medical Stocks Lagging Alvotech (ALVO) This Year?
- Here is how Alvotech (ALVO) and Atossa Genetics Inc. (ATOS) have performed compared to their sector so far this year.
- 06/25/2024
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Here's Why You Should Consider Buying Alvotech (ALVO) Stock
- Here, we discuss some reasons why buying Alvotech (ALVO) stock now may turn out to be a prudent move.
- 06/24/2024
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Alvotech and Advanz Pharma Sign Commercialization Agreement for Proposed Biosimilar to Eylea® LD/HD in Europe
- REYKJAVIK, Iceland and LONDON, June 18, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech's proposed biosimilar to Eylea® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29, a biosimilar candidate for Eylea® high dose (8 mg).
- 06/18/2024
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Alvotech and Advanz Pharma Sign Commercialization Agreement for Proposed Biosimilar to Eylea® LD/HD in Europe
- REYKJAVIK, ICELAND and LONDON, UK (June 18, 2024) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an exclusive partnership agreement regarding the supply and commercialization of Alvotech's proposed biosimilar to Eylea® (aflibercept). Alvotech is currently developing AVT06, a proposed biosimilar to Eylea® low dose (2 mg) and AVT29 a biosimilar candidate for Eylea® high dose (8 mg).
- 06/18/2024
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Alvotech and STADA add to Strategic Alliance through Denosumab Partnership
- REYKJAVIK, Iceland and BAD VILBEL, Germany, June 11, 2024 (GLOBE NEWSWIRE) -- Alvotech and STADA are strengthening their existing strategic alliance for high-quality, cost-effective biosimilars by extending their partnership to cover AVT03, a clinical-stage biosimilar candidate referencing the Prolia®/Xgeva® (denosumab) medicines for osteoporosis and cancer-related bone loss respectively.
- 06/11/2024
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Alvotech Announces Strategic Refinancing Agreement
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the successful arrangement of a strategic refinancing transaction. The financing, led by GoldenTree Asset Management, with participation from other institutional investors (collectively, the “Lenders”), will enable Alvotech (the “Company”) to improve cost of capital, address upcoming debt maturities in 2025 and enhance its financial flexibility by adding incremental cash to the balance sheet.
- 06/07/2024
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2 Generic Drug Makers With Growing Runways
- Brand-name drug costs continue to climb, but patients and insurers find respite by migrating to generic or biosimilar versions as patents run out. Generics are loved by health insurers, Medicare, and patients as they contain the same compounds and active ingredients for a cheaper price.
- 05/31/2024
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Alvotech to Participate in Jefferies Healthcare Conference in New York, June 5-6, 2024
- REYKJAVIK, Iceland, May 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 5-6, 2024. Alvotech will present and host investor and business meetings at the conference.
- 05/29/2024
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Alvotech to Participate in Jefferies Healthcare Conference in New York, June 5-6, 2024
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies Healthcare Conference in New York on June 5-6, 2024. Alvotech will present and host investor and business meetings at the conference.
- 05/29/2024
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Alvotech (ALVO) Q1 2024 Earnings Call Transcript
- Alvotech (NASDAQ:ALVO ) Q1 2024 Earnings Conference Call May 22, 2024 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director, Investor Relations and Global Communications Robert Wessman - Founder, Chairman and Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Conference Call Participants Balaji Prasad - Barclays Vineet Agrawal - Citi Ashwani Verma - UBS Operator Good day, and thank you for standing by. Welcome to the Alvotech Q1 2024 Earnings Conference Call.
- 05/22/2024
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Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update
- REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first three months of 2024 and provided a summary of recent corporate highlights.
- 05/21/2024
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Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update
- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported unaudited financial results for the first three months of 2024 and provided a summary of recent corporate highlights.
- 05/21/2024
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Alvotech and Dr. Reddy's Enter Into Collaboration for Commercialization of AVT03 (denosumab), a Biosimilar Candidate to Prolia® & Xgeva® in the U.S., Europe and UK
- HYDERABAD, India & REYKJAVIK, Iceland--(BUSINESS WIRE)---- $RDY #Alvotech--Alvotech and Dr. Reddy's enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia® & Xgeva®.
- 05/21/2024
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Alvotech and Dr. Reddy's enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia® & Xgeva® in the U.S., Europe and UK
- HYDERABAD, INDIA & REYKJAVIK, ICELAND — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy's”), today announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech's biosimilar candidate to Prolia® and Xgeva® (denosumab). The collaboration combines Dr. Reddy's global commercial presence with Alvotech's proven capabilities in developing biosimilars for markets worldwide.
- 05/21/2024
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Alvotech and Dr. Reddy's enter into collaboration for commercialization of AVT03 (denosumab), a biosimilar candidate to Prolia® & Xgeva® in the U.S., Europe and UK
- HYDERABAD, India and REYKJAVIK, Iceland, May 21, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide (“Alvotech”), and Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as “Dr. Reddy's”), today announced that the companies have entered into a license and supply agreement for the commercialization of AVT03, Alvotech's biosimilar candidate to Prolia® and Xgeva® (denosumab). The collaboration combines Dr. Reddy's global commercial presence with Alvotech's proven capabilities in developing biosimilars for markets worldwide.
- 05/21/2024
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Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.
- PARSIPPANY, N.J. & REYKJAVÍK, Iceland--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Alvotech (NASDAQ: ALVO), today announced the availability of SIMLANDI (adalimumab-ryvk) injection in the U.S., as an interchangeable biosimilar to Humira for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn's disease, adult ulcerative colitis, adult.
- 05/20/2024
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Alvotech S.A. Annual General Meeting to be held June 7, 2024
- The Annual General Meeting of Alvotech S.A. will be held on Friday June 7, 2024, at 09.00 a.m. CEST at the premises of Arendt & Medernach S.A. at 41A, Avenue John F. Kennedy L-1855 Luxembourg, Grand Duchy of Luxembourg.
- 05/15/2024
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Alvotech Announces Webcast of First Quarter 2024 Financial Results on May 22, 2024, at 8:00 am EDT (12 noon GMT)
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2024, after U.S. markets close on Tuesday, May 21, 2024.
- 05/13/2024
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Alvotech Announces Participation at BofA Securities Healthcare Conference 2024
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of management would be participating in the upcoming BofA Securities Healthcare Conference 2024, which will be held on May 14-15, 2024 in Las Vegas, NV.
- 05/02/2024
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U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira® (adalimumab)
- REYKJAVIK, Iceland & PARSIPPANY, N.J. & TEL AVIV, Israel--(BUSINESS WIRE)--Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), disclosed today that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira.
- 04/30/2024
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Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab)
- REYKJAVIK, Iceland, April 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech's proposed biosimilar to Simponi® and Simponi Aria® (golimumab). Alvotech is the first company to announce positive topline results of a clinical trial using a proposed biosimilar to Simponi and Simponi Aria and is one of only two companies known to have initiated such a patient study.
- 04/24/2024
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Alvotech signs U.S. agreement to expand access for newly approved high-concentration interchangeable biosimilar to Humira® (adalimumab)
- REYKJAVIK, Iceland, April 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration (FDA) approved high-concentration interchangeable biosimilar to Humira.
- 04/19/2024
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Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
- REYKJAVIK, Iceland & PARSIPPANY, N.J.--(BUSINESS WIRE)--Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Unde.
- 04/16/2024
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Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)
- REYKJAVIK, Iceland and PARSIPPANY, N.J., April 16, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older. Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI in the United States.
- 04/16/2024
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Alvotech Hosts Audio Call for Investors at 8:15 am EDT on April 3, 2024
- REYKJAVIK, Iceland, April 03, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will host an audio call with a market update at 12:15 pm GMT / 08:15 am EDT on April 3, 2024. Anil Okay, Chief Commercial Officer, will be providing the update.
- 04/03/2024
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Alvotech Hosts Audio Call for Investors at 8:15 am EDT on April 3, 2024
- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will host an audio call with a brief market update at 12:15 pm GMT / 08:15 am EDT. Anil Okay, Chief Commercial Officer, will be providing the update.
- 04/03/2024
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Alvotech Announces Increase in Number of Own Shares
- REYKJAVIK, Iceland, March 22, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) (the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, has increased the Company´s share capital by an amount of one hundred and thirty thousand (USD 130,000) by issuing thirteen million (13,000,000) ordinary shares. The Company's subsidiary, Alvotech Manco ehf. (the “subsidiary”), has subscribed to all of the newly issued shares for a price of USD 15.98 per share. The shares held by the subsidiary are treated as treasury shares without voting rights or dividend entitlement.
- 03/22/2024
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Alvotech (ALVO) Q4 2023 Earnings Call Transcript
- Alvotech (ALVO) Q4 2023 Earnings Call Transcript
- 03/21/2024
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Alvotech settles with J&J to launch Stelara biosimilar in Europe, Canada
- Alvotech said on Thursday it has reached settlement agreements with Johnson & Johnson for launching the biosimilar of the pharmaceutical giant's blockbuster psoriasis drug Stelara in Japan, Canada and the European Economic Area.
- 02/15/2024
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3 mid-caps under $20 that Wall Street loves
- Picking up where it left off last year, artificial intelligence (AI) data center leader NVIDIA Corporation NASDAQ: NVDA is one. Courtesy of a buyout from Hewlett Packard Enterprise Company NYSE: HPE, Juniper Networks Inc. NYSE: JNPR is another.
- 01/23/2024
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Alvotech (ALVO) Up on BLA Update for Two Biosimilar Candidates
- The FDA concludes the reinspection of Alvotech's (ALVO) facility in Iceland. The company believes that it may receive approval for biosimilar candidates, AVT02 and AVT04, in the United States.
- 01/22/2024
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Alvotech (ALVO)'s Technical Outlook is Bright After Key Golden Cross
- From a technical perspective, Alvotech (ALVO) is looking like an interesting pick, as it just reached a key level of support. ALVO's 50-day simple moving average crossed above its 200-day simple moving average, which is known as a "golden cross" in the trading world.
- 12/28/2023
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Alvotech (ALVO) Q3 2023 Earnings Call Transcript
- Alvotech (NASDAQ:ALVO ) Q3 2023 Earnings Conference Call November 29, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director of IR and Global Communications Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Mikaela Franceschina - Barclays Niall Alexander - Deutsche Bank Thibault Boutherin - Morgan Stanley Operator Welcome to Alvotech's Earnings Call for the First Nine Months of 2023. At this time, all participants are in a listen-only mode.
- 11/29/2023
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Alvotech to Present at the Jefferies 2023 London Healthcare Conference
- REYKJAVIK, Iceland, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in the Jefferies London Healthcare Conference taking place in London on November 14-16, 2023.
- 11/07/2023
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Alvotech to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announces its participation in the Morgan Stanley 21st Annual Global Healthcare Conference in New York on September 11–13, 2023.
- 09/11/2023
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Alvotech to Report Financial Results for the First Half of 2023 on August 30, 2023, and Host Business Update Conference Call on August 31, 2023, at 8:00 am ET
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first six months of 2023, after U.S. markets close on Wednesday, August 30, 2023.
- 08/22/2023
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Teva Pharmaceuticals and Alvotech expand biosimilars partnership
- Teva Pharmaceuticals Industries Ltd. TEVA, +0.47% and Alvotech ALVO, +0.51% announced Monday that they are expanding their collaboration in the U.S. biosimilars market.
- 07/24/2023
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Why Shares of Alvotech Are Jumping Friday
- Alvotech specializes in biosimilar medicines. The company received a complete response letter from the FDA regarding the manufacturing facility for its Humira biosimilar, AVT02.
- 06/30/2023
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Alvotech: Precarious Cash Position Dilutes Special Situation Opportunity
- Alvotech has a resolvable CRL. This took down the stock, but when resolved, that could create a quick spike. Ordinarily, this would be an opportunity, except for Alvotech's poor cash position.
- 06/08/2023
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Alvotech to Report First Quarter 2023 Financial Results and Recent Business Highlights on May 18, 2023 and Host Conference Call on May 19, 2023 at 8:00 am ET
- REYKJAVIK, Iceland, May 03, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2023, after U.S. markets close on Thursday, May 18, 2023.
- 05/03/2023
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Alvotech (ALVO) Declines on CRL for Humira's Biosimilar Candidate
- Alvotech's shares decline as it receives a complete response letter for biosimilar candidate, AVT02, treating autoimmune disorders.
- 04/14/2023
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Alvotech to Present Clinical Study Data for AVT04, a Proposed Biosimilar to Stelara®, at 2023 American Academy of Dermatology (AAD) Annual Meeting
- Alvotech ( NASDAQ: ALVO ), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the presentation of two posters related to its clinical studies in support of biosimilarity and clinical comparability of Alvotech's ATV04 (ustekinumab) and the reference product Stelara® at the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21 in New Orleans.
- 03/17/2023
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Alvotech Announces Webcast of 2022 Full Year Financial Results at 8:00 am ET on March 2, 2023
- REYKJAVIK, Iceland, Feb. 28, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for full year 2022, after U.S. markets close on Wednesday, March 1, 2023.
- 02/27/2023
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Competition Coming For AbbVie's Blockbuster Humira
- It's among the prohibitively expensive biologic pharmaceuticals being replaced by cheaper “biosimilar” copycats. Relief is on the way for patients who need Humira, a product made by AbbVie.
- 02/16/2023
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Why Shares of Alvotech Jumped This Week
- The Icelandic biotech company has a deal to expand the reach of its Humira biosimilar in Eastern Europe.
- 12/08/2022
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Alvotech (ALVO) Q3 2022 Earnings Call Transcript
- Alvotech (NASDAQ:ALVO ) Q3 2022 Earnings Conference Call November 16, 2022 8:00 AM ET Company Participants Benedikt Stefansson - Director of Investor Relations and Global Communication Robert Wessman - Executive Chairman & Founder Anil Okay - Chief Commercial Officer Mark Levick - Chief Executive Officer Joel Morales - Chief Financial Officer Conference Call Participants Mark Bavoso - Morgan Stanley Andrew Baum - Citi Carl Byrnes - Northland Capital Markets Ash Verma - UBS Operator Good day, and thank you for standing by. Welcome to the Alvotech Third Quarter 2022 Earnings Conference Call.
- 11/16/2022
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Alvotech to Present Switching Study Data for AVT02, a Proposed Biosimilar to Humira®, at 2022 American College of Rheumatology Conference
- REYKJAVIK, Iceland, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will present two posters and will be featured in an Ignite Talk related to its switching study for ATV02 at the American College of Rheumatology (ACR) Convergence Conference, being held in Philadelphia on November 10-14, 2022.
- 11/10/2022
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Alvotech to Report First Nine Months Financial Results on November 15, 2022 and Host Business Update Conference Call at 8:00 am ET on November 16, 2022
- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first nine months of 2022, after U.S. markets close on Tuesday, November 15, 2022.
- 10/27/2022
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Alvotech (ALVO) Q2 2022 Earnings Call Transcript
- Alvotech (NASDAQ:ALVO ) Q2 2022 Earnings Conference Call September 1, 2022 8:00 AM ET Company Participants Benedict Stephan - Investor Relations Robert Wessman - Executive Chairman & Founder Mark Levick - Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Ming Li - Chief Strategic Officer Conference Call Participants Tybalt Mornan - Morgan Stanley Karen Marchetti - Northland Jason Guerra - Bank of America Benedict Stephan [Call Started Abruptly] materials and some of our statements that we make today may include forward looking statements. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission, and the Nasdaq Iceland Stock Exchange.
- 09/01/2022
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Alvotech to Participate in Two Upcoming Investor Conferences in September 2022
- REYKJAVIK, Iceland and NEW YORK, Aug. 24, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that members of the leadership team will participate in two upcoming investor conferences in September 2022. Representatives of Alvotech will hold two fireside chats:
- 08/24/2022
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Alvotech to Report First Six Months and Second Quarter 2022 Financial Results on August 31, 2022 and Host Business Update Conference Call at 8:00 am ET on September 1, 2022
- REYKJAVIK, Iceland, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first six months and second quarter of 2022, after U.S. markets close on Wednesday, August 31, 2022.
- 08/15/2022
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