Invivyd收到Pemgarda EUA终止通知

2026-07-06 19:36

Invivyd (IVVD) received a notice from the U.S. Food and Drug Administration terminating the emergency use authorization for PEMGARDA, its monoclonal antibody for COVID-19 prevention, effective June 29, 2027.
The termination follows the U.S. Department of Health and Human Services’ announcement of advanced notice of termination of the COVID-19 EUA declaration on June 30, 2026.
PEMGARDA received emergency use authorization from the FDA in March 2024. The drug is authorized for pre-exposure prophylaxis of COVID-19 in immunocompromised patients.
Invivyd said it is in dialogue with the FDA on next steps.
IVVD shares initially fell about -6% in premarket trading before reversing course to trade up +1.8%.

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