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Tag: Stockholm:ALVO SDB

Transactions of Managers and Closely Associated Persons

Attached is a copy of a filing with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) regarding a transaction of managers and closely associated persons, announcing the allocation of shares to a director of the board of Alvotech in accordance with his remuneration package.

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee in Switzerland

Alvotech acquires capability and added flexibility in assembly and packaging with acquisition of Ivers-Lee Group

Notification for the purposes of article 13 of the Luxembourg law of 11 January 2008 on transparency requirements for issuers    

Luxembourg (July 3, 2025) – Alvotech S.A. announces that on June 25, 2025, the proportion of own shares held by Alvotech S.A. reached 6.73%, crossing above the 5% threshold of the total number of voting rights. The above percentage has been calculated on the basis of 22,484,087 own shares out of 334,038,147 shares in issue to which voting rights are attached.

Granting of Stock Options and Vesting of Restricted Share Units

In accordance with the Remuneration Policy of Alvotech (the “Company”), which was approved at the Company’s Annual General Meeting (“AGM”) on June 6, 2023, at the 2025 AGM held on June 25, 2025, four independent board directors each received a stock option grant allowing the purchase of up to 24,784 Alvotech shares.

Úthlutun nýrra kauprétta og afhending áunninna hlutabréfaréttinda

Í samræmi við starfskjarastefnu sem samþykkt var á aðalfundi Alvotech þann 6. júní 2023 og þar sem nýtt starfsár stjórnar hefst með aðalfundi, voru á aðalfundi félagsins sem haldinn var 25. júní sl. veittir kaupréttir til fjögurra óháðra stjórnarmanna. Hver stjórnarmaður fékk rétt til kaupa á alls 24.784 hlutum í Alvotech.

Positive Top Line Results from Confirmatory Efficacy Study for Proposed Biosimilar to Xolair® (omalizumab)

REYKJAVIK, ICELAND, PISCATAWAY, NEW JERSEY AND LONDON, UK (June 25, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacturing of biosimilar medicines for patients worldwide, Kashiv Biosciences LLC (“Kashiv”), a fully integrated biopharmaceutical company headquartered in New Jersey, US, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK-headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced positive topline results from a confirmatory efficacy study comparing AVT23 (ADL-018), a proposed biosimilar to Xolair® (omalizumab), with the reference biologic.

Jákvæð niðurstaða úr klínískri rannsókn fyrir fyrirhugaða hliðstæðu Alvotech við líftæknilyfið Xolair

Alvotech (NASDAQ: ALVO) og samstarfsaðilar félagsins, Kashiv Biosciences og Advanz Pharma, kynntu í dag að jákvæð niðurstaða hefði náðst í klínískri rannsókn sem bar saman virkni AVT23, fyrirhugaðrar hliðstæðu líftæknilyfsins Xolair (omalizumab), og virkni frumlyfsins. Xolair er lyf sem gefið er við ofnæmisastma og fleiri skyldum sjúkdómum. Kashiv Biosciences er líftæknifyrirtæki með höfuðstöðvar í New Jersey í Bandaríkjunum. Advanz Pharma er alþjóðlegt lyfjafyrirtæki sem markaðssetur lyfseðilsskyld lyf, stungu- og innrennslislyf og lyf við sjaldgæfum sjúkdómum. Það er með höfuðstöðvar í Bretlandi.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland and LONDON, June 23, 2025 (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 European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

European Medicines Agency Recommends Market Approval of AVT06, Alvotech’s Proposed Biosimilar to Eylea® (aflibercept)

REYKJAVIK, ICELAND and LONDON, UK (June 23, 2025) — 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’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept 2 mg). Based on a positive recommendation by CHMP, biosimilar medicines can be approved by the European Commission for marketing in the European Economic Area, that includes the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein.

Öll bréf afhent kaupendum í hlutafjárútboði Alvotech

Alvotech (NASDAQ: ALVO, ALVO-SDB) tilkynnti í dag að fyrirtækið afhent bréf til þátttakenda í lokuðu hlutafjárútboði sem fram fór þann 4. júní sl. Um 40 stofnanafjárfestar tóku þátt í útboðinu. Um 60% af heildareftirspurninni kom frá fjárfestum í Svíþjóð, Noregi og Bretlandi, um 30% frá sjóðum í Bandaríkjunum og um 10% frá Íslandi. Yfir 80% bréfanna voru keypt af fjárfestum sem eru nýir hluthafar í Alvotech.

Alvotech’s Private Placement Completed with Delivery of SDRs and Shares to Investors

Alvotech (NASDAQ: ALVO, ALVO-SDB, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement that was carried out on June 4, 2025, directed to Swedish and international institutional investors. About 40 institutional investors participated in the placement. About 60% of the demand came from institutional investors based in Sweden, Norway or the UK, and about 30% from US-based funds. Over 80% of the shares and Swedish Depositary Receipts (SDRs) allocated in the placement, were sold to investors that were not previously shareholders in Alvotech.

Alvotech’s Private Placement Completed with Delivery of SDRs and Shares to Investors

Alvotech (NASDAQ: ALVO, ALVO-SDB, the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the completion of a private placement that was carried out on June 4, 2025, directed to Swedish and international institutional investors. About 40 institutional investors participated in the placement. About 60% of the demand came from institutional investors based in Sweden, Norway or the UK, and about 30% from US-based funds. Over 80% of the shares and Swedish Depositary Receipts (SDRs) allocated in the placement, were sold to investors that were not previously shareholders in Alvotech.

Alvotech Participates in the Goldman Sachs Global Healthcare Conference in Miami

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 Goldman Sachs 46th Global Healthcare Conference, which will be held in Miami, Florida June 9-11, 2025. Members of the management team will host one-on-one meetings at the conference. Dr. Balaji Prasad, Chief Strategy Officer, will participate in a fireside chat on Wednesday June 11, 2025, at 8:00 am EDT (12:00 GMT / 14:00 CEST).

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