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Alvotech (ALVO)

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Recent press releases and 8-K filings for ALVO.

Alveus Therapeutics Announces Completion of Series A Financing Round
ALVO
New Projects/Investments
Board Change
  • Alveus Therapeutics Inc. has completed the second and final closing of its oversubscribed Series A financing, increasing the total round size to $197 million.
  • The additional capital will support the clinical development of ALV-100 and ALV-200, and the continued advancement of its differentiated amylin-based pipeline.
  • New investors include Jeito Capital and Novo Holdings, joining the original syndicate led by New Rhein Healthcare Investors, Andera Partners, and Omega Funds.
  • Ksenija Pavletic, General Partner and CCO at Jeito Capital, will join the Alveus Board of Directors in conjunction with the Series A extension.
4 days ago
Alvotech Increases Share Capital and Treasury Share Holdings
ALVO
  • Alvotech increased its share capital by USD 125,000 through the issuance of 12,500,000 ordinary shares.
  • The company's subsidiary, Alvotech Manco ehf., subscribed to all newly issued shares at USD 5.2 per share.
  • Following this transaction, the subsidiary now holds 16,254,005 shares, representing 4.7% of issued shares, and the total issued shares increased from 334,038,147 to 346,538,147.
  • The number of outstanding shares remains unchanged at 330,284,142.
  • The capital increase is intended to replenish treasury shares after a stock lending facility for Convertible Bond investors and to fulfill commitments related to financial obligations, including warrants and other convertible financial instruments.
Feb 11, 2026, 4:00 PM
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.
Feb 5, 2026, 12:00 PM
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.
Feb 5, 2026, 8:00 AM
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.
Feb 2, 2026, 12:00 PM
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.
Feb 2, 2026, 8:00 AM
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
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