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News  ›  GlobeNewswire Inc.

Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Benedikt Stefansson
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.

Insights
FLGpU   positive

The bank is maintaining consistent dividend payments across multiple stock classes, indicating financial stability and commitment to shareholder returns


ALVO   negative

Received FDA Complete Response Letter, lowered financial projections, and must resolve manufacturing facility issues before product approval