On November 2, 2025, Alvotech published a press release notifying investors that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for ATV05. The CRL noted that certain deficiencies must be resolved before the BLA for ATV05 can be approved. Alvotech had submitted a Corrective and Preventive Action (CAPA) plan to the FDA following a previous inspection of the Company’s facility. Management stated that Alvotech is “disappointed” in receiving the CRL.
Following this news, Alvotech’s stock price fell over 34.2% to close at $5.03 per share on November 3, 2025.
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