On April 13, 2023, Alvotech disclosed that it received communication from the U.S. Food and Drug Administration (“FDA”) regarding the FDA’s March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland. According to Alvotech, the FDA noted certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before the FDA can approve the Company’s Biologics License Application (BLA) for AVT02
On this news, Alvotech’s stock price fell $3.03, or 22.1%, to close at $10.66 per share on April 14, 2023, thereby injuring investors.
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