Invivyd, Inc. — Form 8-K
Filed July 6, 2026 · analyzed by the 8-K Agent
8-K
▼ Likely negative
significance 92/100
What the filing says
Invivyd received FDA Notice of Termination for PEMGARDA's COVID-19 Emergency Use Authorization, effective June 29, 2027, following HHS termination of the COVID-19 EUA declaration. The company has a 12-month transition period and is in dialogue with FDA on next steps, stating it believes PEMGARDA has sufficient clinical data to support a full Biologics License Application (BLA) submission and approval. PEMGARDA, approved under EUA in March 2024 for pre-exposure prophylaxis in immunocompromised patients, is Invivyd's primary commercial product.
Why this rating
PEMGARDA is Invivyd's only approved/authorized product; EUA termination in 12 months removes primary revenue source for $51M company unless BLA approved. Existential threat.
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