FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who ...
Invivyd, Inc. (IVVD)
Company Research
Source: GlobeNewswire
FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody (mAb) must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the known and potential risks”Invivyd’s submission to expand the PEMGARDA™ EUA to include COVID-19 treatment for certain immunocompromised patients who have no other therapeutic options provided the FDA with analyses demonstrating comparable antiviral activity between pemivibart and adintrevimab, the key antibody of interest for immunobridging, as well as analyses demonstrating predicted pemivibart clinical efficacy in-line with prior authorized mAb therapeutics, and well above currently authorized convalescent plasmaIn parallel wi
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IVVD
News
- A Look at Invivyd (IVVD) Valuation After Advancing VBY329 RSV Antibody Candidate into Preclinical Development [Yahoo! Finance]Yahoo! Finance
- Invivyd (NASDAQ:IVVD) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Invivyd (NASDAQ:IVVD) was downgraded by analysts at D Boral Capital from a "strong-buy" rating to a "hold" rating.MarketBeat
- Invivyd (NASDAQ:IVVD) had its "hold" rating reaffirmed by analysts at D. Boral Capital.MarketBeat
- Invivyd to Participate at the 8th Annual Evercore Healthcare Conference [Yahoo! Finance]Yahoo! Finance
IVVD
Earnings
- 11/6/25 - Miss
IVVD
Sec Filings
- 11/25/25 - Form SCHEDULE
- 11/24/25 - Form 8-K
- 11/20/25 - Form 4
- IVVD's page on the SEC website