Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA

Invivyd received a Notice of Termination for the PEMGARDA EUA from the FDA, effective June 29, 2027, following the HHS decision to end the COVID-19 emergency declaration. The company has a twelve-month transition period to work with regulators on next steps, with management stating its belief that current data supports a Biologics License Application (BLA) submission.

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