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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%.
More on Invivyd
- Invivyd, Inc. 2026 Q1 - Results - Earnings Call Presentation
- Invivyd, Inc. (IVVD) Q1 2026 Earnings Call Transcript
- Invivyd: Why The Trial Upsizing Isn't The Green Light Bulls Think It Is
- Invivyd outlines VYD2311 path as PEMGARDA grows 22% year-over-year while DECLARATION recruitment nears completion
- Invivyd Q1 2026 Earnings Preview
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