Welcome to our dedicated page for Alvotech news (Ticker: ALVO), a resource for investors and traders seeking the latest updates and insights on Alvotech stock.
Alvotech (NASDAQ: ALVO) is a biotechnology company dedicated exclusively to biosimilars, and its news flow reflects the progress of a global biosimilar platform. Company updates frequently cover regulatory milestones, such as marketing authorizations in the European Economic Area, the United Kingdom and Japan for products referencing Prolia and Xgeva (denosumab), Simponi (golimumab) and Eylea (aflibercept). Press releases also highlight clinical and regulatory developments for new candidates, including submissions to agencies like the European Medicines Agency and the U.S. Food and Drug Administration.
Investors following ALVO news can expect regular announcements on product approvals, pipeline progress and legal or regulatory outcomes. Recent communications have described European Commission approval of AVT03, a biosimilar to Prolia and Xgeva, positive opinions from EMA committees for AVT03 and AVT05, and a settlement and license agreement enabling a future U.S. launch of AVT06, a proposed biosimilar to Eylea, subject to FDA approval. Other items include court decisions related to manufacturing activities for AVT06 and updates on applications for additional candidates such as AVT23.
Alvotech’s news flow also includes capital markets and financing transactions, such as senior unsecured convertible bond offerings and a senior term loan facility, which the company states are intended to support its research and development pipeline, manufacturing capacity and global product launches. Earnings-related press releases and business updates provide guidance ranges for revenues and adjusted EBITDA, along with commentary on order books, launch timing and investment programs.
Corporate governance and leadership changes are another recurring theme. For example, Alvotech has announced a planned CEO succession in which the founder will remain as Executive Chairman while a new Chief Executive Officer takes over day-to-day leadership. For users tracking ALVO, this news page offers a centralized view of regulatory, financial and strategic developments affecting the company’s biosimilar portfolio and global partnerships.
Alvotech (ALVO) filed a notification with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) on 29 Dec 2025 regarding changes in the company's own shares. An attachment titled Alvotech Own Shares Notification 29 Dec 2025 was submitted with the filing. Investors should review the attached notification for the specific details and scope of the share changes.
Alvotech (NASDAQ: ALVO) published its 2026 financial calendar with scheduled dates for interim and annual results, investor calls and the annual general meeting. Results are released after U.S. market close and an investor call follows the next day.
- Mar 18, 2026 – Q4 2025 / full-year 2025 results
- May 6, 2026 – Q1 2026 results
- Jun 3, 2026 – Annual General Meeting (Luxembourg)
- Aug 19, 2026 – Q2 2026 / first six months
- Nov 11, 2026 – Q3 2026 / first nine months
- Mar 10, 2027 – Q4 2026 / full-year 2026
All dates are subject to change. Investor relations contacts were provided for follow-up.
Alvotech (NASDAQ: ALVO) announced European launches beginning December 22, 2025 for Gobivaz (golimumab, AVT05), its biosimilar to Simponi. Gobivaz is described as the first marketed biosimilar to Simponi worldwide and will be commercialized exclusively in Europe by partner Advanz Pharma. In the UK, adoption is supported by an NHS England tender award, providing a defined procurement framework. Availability across EEA countries will follow national pricing and reimbursement processes. Approval was supported by analytical, pre-clinical and clinical studies; Gobivaz is offered in the same presentations and dosages as the reference product and is manufactured at Alvotech’s facility in Iceland.
Alvotech (NASDAQ: ALVO) and Teva reached a settlement and license agreement with Regeneron allowing Alvotech’s proposed biosimilar AVT06 (aflibercept) to be marketed in the U.S. in Q4 2026, or earlier under certain circumstances, if approved by the FDA. AVT06 has received marketing approvals in the United Kingdom, Japan and the 30 countries of the European Economic Area. A January 2024 confirmatory clinical study met its primary endpoint, showing high similarity to Eylea® in neovascular AMD. The settlement and Teva partnership position Alvotech for a potential U.S. launch pending FDA approval.
Alvotech (NASDAQ: ALVO) has placed USD 108 million senior unsecured convertible bonds due 22 December 2030 in a significantly oversubscribed private offering.
The bonds carry a 6.875% coupon, are issued at par, convert from day 41, and have an initial conversion price of USD 5.9224 (25% premium over USD 4.7379). Net proceeds will fund R&D, scaling production and four global product launches through 2026; the company expects R&D spend of about USD 250 million in 2026.
Concurrent activity included a USD ~56 million placement of existing shares to hedge bond investors, a full stock-lending facility, and lock-ups of 3 and 12 months for new shares and equity-linked securities.
Alvotech (NASDAQ: ALVO) launched a USD 100 million senior unsecured convertible bond offering due 2030 to fund R&D, manufacturing scale-up, global product launches and liquidity. The company plans to invest ~USD 250 million in R&D in 2026 and targets launching 4 new products globally during 2026, with three global launches already taking place in December 2025.
Alvotech reaffirmed 2025 guidance: $570–$600M revenue and $130–$150M adjusted EBITDA, and provided 2026 guidance: $650–$700M revenue and $180–$220M adjusted EBITDA. The company disclosed a U.S. settlement with Regeneron for AVT06 and noted potential FDA CRLs that could affect timing.
Alvotech (NASDAQ: ALVO) announced on November 24, 2025 that the European Commission approved AVT03 as a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area.
AVT03 is approved in two presentations: 60 mg/mL pre-filled syringe for osteoporosis (Prolia) and 70 mg/mL vial for prevention of skeletal related events in advanced malignancies (Xgeva). The European denosumab market is stated at approximately US$1.2 billion in the last 12 months through Q2 2025. Commercialisation in Europe will be via partnerships with STADA and Dr. Reddy’s under semi-exclusive rights.
Alvotech (NASDAQ: ALVO) and Advanz Pharma announced that the European Commission granted marketing authorizations across the EEA for Gobivaz® (golimumab biosimilar) on Nov 20, 2025.
The approvals cover 50 mg/0.5 mL and 100 mg/mL in pre-filled syringe and autoinjector formats for adult indications including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, and for juvenile idiopathic arthritis in children aged 2 years and older.
The EC decision follows a positive CHMP opinion in September and relied on analytical and clinical data, including positive confirmatory study topline results announced in April 2024.
Alvotech (NASDAQ: ALVO) reported first nine months 2025 results: total revenues $420.0M (+24% YoY), product & service revenue $237.4M (+85% YoY) and adjusted EBITDA $68M (down 21% YoY). The company reiterated a revised full‑year outlook of $570–$600M revenue and $130–$150M adjusted EBITDA.
Operational highlights include multiple marketing approvals and positive CHMP opinions in Japan and Europe, a $42.8M cash balance at 30‑Sep‑2025, $1.1B total borrowings, a $100M new working capital facility, and appointment of Joseph McClellan as COO. An earnings call is scheduled for Nov 13, 2025.
Alvotech (NASDAQ: ALVO) said the European Medicines Agency CHMP issued a positive opinion recommending approval of AVT03, its proposed biosimilar to Prolia® (denosumab 60 mg/mL pre-filled syringe) and Xgeva® (denosumab 70 mg/mL vial), on September 22, 2024. The company said AVT03 remains under EMA review with a final European Commission decision pending. Upon approval, commercial partners STADA and Dr. Reddy’s will market the product in Europe under semi-exclusive rights with assigned tradenames Kefdensis, Zvogra, Acvybra and Xbonzy.
This step affects access to denosumab therapies indicated for osteoporosis, fracture risk and oncology bone complications and moves AVT03 closer to potential European commercialization pending the final regulatory decision.