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REYKJAVIK, Iceland, August 31, 2026 - 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 AVT80, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) prefilled syringe and autoinjector for subcutaneous administration.
REYKJAVIK, ICELAND (August 27, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows:
U.S. stocks were mixed, with the Dow Jones index gaining around 150 points on Monday.
REYKJAVIK, Iceland, Aug. 21, 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 a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech's candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi® (durvalumab), and AVT87, a proposed biosimilar to Hemlibra® (emicizumab).
Alvotech maintains at a Hold rating due to missed H1 2026 earnings and ongoing regulatory challenges, despite pipeline progress. Recent FDA CRLs for AVT05 and AVT06 were due to manufacturing issues, now addressed, with BLAs resubmitted and multiple approvals targeted for Q4 2026. AVT06, a biosimilar to EYLEA, has global commercialization rights secured post-November 2026, with patent disputes resolved and a large market opportunity.
Alvotech (ALVO) Q2 2026 Earnings Call Transcript
Alvotech NASDAQ: ALVO said its first-half 2026 results reflected a temporary manufacturing slowdown tied to facility and quality-system improvements at its Reykjavik site, while management reaffirmed full-year revenue and adjusted EBITDA guidance and highlighted upcoming regulatory decisions and product launches.
Alvotech (ALVO) came out with a quarterly loss of $0.11 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to earnings of $0.14 per share a year ago.