secwatch.observer — SEC 8-K summary
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Issuer:     NOVAVAX INC (NVAX)
CIK:        0001000694
Form:       8-K
Filed at:   2024-06-06T23:59:59+00:00
Accession:  0001104659-24-068875
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1000694/000110465924068875/0001104659-24-068875-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1000694/000110465924068875/tm2416490d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-068875

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