Novavax FDA sets PDUFA date April 2025 for COVID vaccine BLA; plans EUA sales for 2024-2025

NOVAVAX INC

FDA completed BLA filing review; PDUFA goal date set for April 2025 for COVID-19 vaccine.
Company to sell COVID-19 vaccine under EUA for 2024-2025 season in U.S.
Plans to initiate pivotal Phase 3 trial for COVID-Influenza Combination (CIC) in H2 2024.
Targeting updated single-dose vial COVID vaccine for 2024-2025 season; possible combo vaccine launch in 2026.
Continuing global restructuring and cost reduction plan to manage cash flow.

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