Kirby McInerney LLP has initiated an investigation into Alvotech following the company's receipt of a complete response letter from the U.S. Food and Drug Administration on November 3, 2025. The correspondence relates to a failed facility inspection conducted in July 2025, which prompted the regulatory agency to decline approval of the company's pending applications.
The announcement of the FDA's complete response letter precipitated a sharp decline in Alvotech's stock price, falling 34.25% from $7.65 to $5.03 per share. The substantial equity depreciation reflects investor concern regarding the company's regulatory standing and timeline for product approvals.
The law firm is currently evaluating whether violations of securities laws occurred in connection with the FDA inspection findings and subsequent stock decline. Kirby McInerney LLP is soliciting investors who experienced losses to participate in potential litigation seeking to recover damages.