$0.90 -0.21 (-18.92%)
Alvotech Warrant (ALVOW)
Company News
Alvotech Shares Plunge 33% After FDA Flags Issues
Biotech company Alvotech received a complete response letter from the FDA for its biosimilar drug AVT05, citing manufacturing facility deficiencies. The company's stock dropped significantly, and it revised its 2025 revenue and EBITDA projections downward.
Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05
Alvotech received a Complete Response Letter (CRL) from the FDA for its biosimilar candidate AVT05, requiring resolution of certain manufacturing facility deficiencies before approval. The company expects to address the issues and work with the FDA, but has lowered its 2025 revenue and EBITDA projections.