Invivyd receives 12-month notice of EUA termination for PEMGARDA, plans FDA dialogue

Invivyd received FDA notice that PEMGARDA's EUA will terminate on June 29, 2027, after a 12-month transition following HHS's EUA declaration termination notice.

Key Highlights:

• HHS announced termination of the COVID-19 EUA declaration; effective date set for June 29, 2027.
• FDA issued Invivyd a Notice of Termination for the PEMGARDA EUA effective June 29, 2027, with a 12-month transition.
• Invivyd is in active dialogue with FDA about appropriate next steps and regulatory pathways for PEMGARDA.
• Company intends to pursue BLA or other avenues, citing clinical and post-authorization data supporting PEMGARDA's efficacy and safety.
• PEMGARDA remains an investigational mAb authorized since March 2024 for pre-exposure prophylaxis in certain immunocompromised patients.

Original SEC Filing:

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