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Alvotech (ALVO)

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Recent press releases and 8-K filings for ALVO.

Alvotech Announces Positive Top-Line Results for Entyvio Biosimilar Candidate
ALVO
Product Launch
New Projects/Investments
  • Alvotech announced positive top-line results from a pivotal pharmacokinetic (PK) study for AVT80, its proposed biosimilar to Entyvio® (vedolizumab).
  • The study met all primary endpoints, demonstrating PK similarity to Entyvio and marking an important milestone for regulatory submissions for both AVT80 and AVT16, Alvotech's biosimilar candidates for subcutaneous and intravenous administration, respectively.
  • Entyvio, the reference product, generated approximately US$6.4 billion in combined net revenues worldwide in 2025.
2 days ago
Alvotech Announces Positive Results for Entyvio Biosimilar Study
ALVO
Product Launch
New Projects/Investments
  • Alvotech announced positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio® (vedolizumab).
  • The study, which compared AVT80 to Entyvio in healthy adult participants, met all its primary endpoints, demonstrating PK similarity.
  • This milestone is crucial for regulatory submissions for both AVT80 (subcutaneous) and AVT16 (intravenous), Alvotech's proposed biosimilars to Entyvio.
  • Entyvio, the reference product, generated approximately US$6.4 billion in combined net revenues worldwide in 2025.
2 days ago
Alvotech Enters Supply and Commercialization Agreements with Sandoz
ALVO
New Projects/Investments
Product Launch
  • Alvotech announced on February 2, 2026, that it has entered into supply and commercialization agreements with Sandoz.
  • These agreements cover multiple biosimilar candidates in Canada, Australia, and New Zealand.
  • The Canadian agreement includes one biosimilar candidate in ophthalmology, and the Australia and New Zealand agreement covers three biosimilar candidates across immunology and gastroenterology.
  • Sandoz will manage regulatory submissions, commercialization, and distribution, while Alvotech will retain responsibility for development, global clinical activities, manufacturing, and supply of the finished product.
5 days ago
Alvotech Enters Supply and Commercialization Agreements with Sandoz
ALVO
New Projects/Investments
Product Launch
  • Alvotech has entered into supply and commercialization agreements with Sandoz for multiple biosimilar candidates in Canada, Australia, and New Zealand.
  • The agreements cover one biosimilar candidate in ophthalmology for Canada and three biosimilar candidates across immunology and gastroenterology for Australia and New Zealand.
  • Sandoz will be responsible for regulatory submissions, commercialization, and distribution in these regions, while Alvotech will handle development, global clinical activities, manufacturing, and product supply.
  • These partnerships advance Alvotech’s strategy of securing commercial pathways for its biosimilars portfolio and aim to support broad patient access following regulatory approvals and market launches.
5 days ago
Alvotech Secures Global Settlement for Eylea Biosimilar
ALVO
Legal Proceedings
Product Launch
  • Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to its biosimilar to Eylea® 2mg.
  • This agreement grants Alvotech worldwide rights to manufacture and supply its aflibercept biosimilar to commercial partners.
  • The settlement allows Alvotech and its partners to market and sell the biosimilar in the United Kingdom and Canada as of January 1, 2026.
  • Market entry is also permitted in the European Economic Area and other global countries (excluding the U.S.) starting May 1, 2026, and in Japan from May 1, 2026 (with all approved indications from November 1, 2026).
  • A previously announced agreement granted a Q4 2026 license entry date for the U.S., pending regulatory approval.
Jan 29, 2026, 12:00 PM
Alvotech Secures Global Settlement for Eylea Biosimilar
ALVO
Legal Proceedings
Product Launch
  • Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining worldwide patent disputes for its Eylea® 2mg biosimilar (aflibercept).
  • This agreement, combined with a previously announced U.S. settlement, grants Alvotech worldwide rights to manufacture and supply its aflibercept biosimilar to commercial partners.
  • The settlement permits marketing and sales of the biosimilar starting January 1, 2026, in the United Kingdom and Canada, and from May 1, 2026, in the European Economic Area and other global markets (excluding the U.S.).
  • For Japan, sales will commence May 1, 2026 (excluding the diabetic macular edema indication) and November 1, 2026, for all approved indications.
Jan 29, 2026, 8:00 AM
Alveus Therapeutics Announces FDA Clearance and First Patient Dosed for ALV-100
ALVO
Product Launch
New Projects/Investments
  • Alveus Therapeutics announced on January 23, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ALV-100.
  • The first patient was dosed last week in a Phase 1b clinical study for ALV-100, which is designed for chronic weight management in adults with overweight or obesity.
  • ALV-100 is a bifunctional glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist / glucagon-like peptide-1 receptor (GLP-1R) agonist fusion protein.
  • The company aims for Phase 3 readiness in the second half of 2027.
Jan 23, 2026, 12:30 PM
Alveus Therapeutics Launches with Series A Financing
ALVO
New Projects/Investments
Product Launch
Board Change
  • Alveus Therapeutics Inc., a clinical-stage biotechnology company focused on obesity and metabolic diseases, has launched with a $159.8 million Series A financing.
  • The financing will fund Phase 2 clinical development of ALV-100, the company's lead program, and Investigational New Drug (IND) filings for other early proprietary development candidates, including a highly selective Amylin peptide agonist.
  • The Series A round was led by New Rhein Healthcare Investors, Andera Partners, and Omega Funds, with participation from other healthcare investors.
  • ALV-100 is a bifunctional GIPR antagonist / GLP-1R agonist designed for durable weight management.
Jan 8, 2026, 12:30 PM
Alvotech reports insider share transactions by ATP Holdings ehf.
ALVO
  • ATP Holdings ehf., an entity closely associated with Alvotech's CEO and chairman, Róbert Wessman, acquired 4,812,257 shares in Alvotech on December 17, 2025, at a price of SEK 44.06 per share.
  • On December 19, 2025, ATP Holdings ehf. also sold 2,110,640 shares in Alvotech at SEK 44.06 per share.
  • This announcement, published on January 7, 2026, corrected an earlier company announcement from January 6, 2026, which had incorrectly stated the December 19, 2025, transaction as an acquisition.
Jan 7, 2026, 10:30 PM
Alvotech: Associated Entities Acquire Shares in December 2025
ALVO
  • Alvogen Lux Holdings Sarl, an entity closely associated with Alvotech's CEO and Chairman Robert Wessman, and Board Members Tomas Ekman and Arni Hardarson, acquired 7,007,321 shares of Alvotech at a price of SEK 44.06 per share on December 17, 2025.
  • ATP Holdings ehf., also closely associated with Alvotech's CEO and Chairman Róbert Wessman, acquired a total of 6,922,897 shares in two separate transactions.
  • These acquisitions by ATP Holdings ehf. occurred on December 17, 2025, for 4,812,257 shares, and on December 19, 2025, for 2,110,640 shares, both at a price of SEK 44.06 per share.
Jan 7, 2026, 4:00 PM
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