Novavax says FDA missed PDUFA deadline for COVID-19 vaccine BLA; still awaiting decision

NOVAVAX INC

FDA's April 1 PDUFA date passed; no official decision received as of April 2, 2025.
Novavax completed all FDA information requests and believes BLA is ready for approval.
Phase 3 data cited showing vaccine is safe and effective for COVID-19 prevention.
Company positions its vaccine as an attractive alternative to mRNA COVID-19 vaccines in U.S.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.