Alvotech stock crashes 34% after FDA rejects key drug application
ALVO Investor News: If You Have Suffered Losses in Alvotech (NASDAQ: ALVO), You Are Encouraged to Contact The Rosen Law Firm About Your Rights
NEW YORK, Dec. 06, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities...
2025-12-06T19:55:45+00:00
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Alvotech faced a sharp decline in its stock price after the US Food and Drug Administration (FDA) rejected its drug application. The company’s shares fell by 34% on November 3, 2025, following the announcement. Legal action may now follow as investors seek compensation for potential losses.
The FDA issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05. This decision came after inspectors identified deficiencies at the company’s manufacturing facility in Reykjavík, Iceland, during a pre-approval visit in July 2025.
The FDA’s rejection of AVT05 has triggered both financial and legal consequences for Alvotech. Investors are now exploring options for recovering losses, while the company faces scrutiny over its regulatory compliance. The outcome of the Rosen Law Firm’s investigation could determine whether further legal steps will be taken.
