On November 2, 2025, Alvotech issued a press release entitled “Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05.” It stated that the ” U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations[.]” Further, the “CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved.”
On this news, Alvotech’s stock price fell 34% on November 3, 2025, and nearly 4% on November 4, 2025.
