Invivyd Receives 12-Month Notice of PEMGARDA EUA Termination from FDA
IVVD sits 74% above its 52-week low of $0.483.
Summary
Invivyd announced the FDA will terminate the Emergency Use Authorization for its COVID-19 antibody, PEMGARDA, by June 29, 2027, creating uncertainty for the product's future.
Key Events · Product Development and Regulatory · IVVD
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EUA Termination Notice Received
Invivyd received a 12-month advanced notice from the FDA regarding the termination of the Emergency Use Authorization (EUA) for PEMGARDA, effective June 29, 2027.
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Regulatory Uncertainty for Key Product
PEMGARDA, an investigational monoclonal antibody for COVID-19 prevention, has been authorized under EUA since March 2024 and is described as a critical non-vaccine option. Its future commercialization depends on securing full BLA approval.
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Company Pursuing BLA Approval
Invivyd is in active dialogue with the FDA to pursue a Biologics License Application (BLA) for PEMGARDA, stating it believes the product has sufficient clinical and post-authorization data to support approval.
Analysis · IVVD · Life Sciences
Invivyd's primary COVID-19 antibody, PEMGARDA, faces termination of its Emergency Use Authorization (EUA) by June 29, 2027. This creates significant regulatory uncertainty and could impact future revenue if the company fails to secure full Biologics License Application (BLA) approval within the transition period. The company states it is in active dialogue with the FDA to pursue a permanent approval pathway.
How filings like this one have moved
In the 30 days to Sep 14, 2026, 35.8% of the 1045 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was -0.43%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, IVVD was trading at $0.84 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $263.3M. The 52-week trading range was $0.48 to $3.07. This filing was assessed with negative market sentiment and an importance score of 8 out of 10.