EUA, FDA and Invivyd

FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
Invivyd says FDA declines request to expand existing EUA of PEMGARDA
Invivyd (IVVD) announced that Invivyd’s request to expand the existing emergency use authorization for pre-exposure prophylaxis of COVID-19 EUA
Invivyd shares drop as FDA declines company's COVID-19 treatment EUA expansion
Monday said that its request to expand the existing emergency use authorization of PEMGARDA (pemivibart) to include treatment of mild-to-moderate COVID-19 for immunocompromised persons who have no alternative therapeutic options,
Invivyd Shares Down as Regulators Decline Expanded Use for Covid-19 Treatment
The commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more people was declined by the Food and Drug Administration.
Invivyd, Inc.: FDA Declined Invivyd's Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart)
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
FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients
Invivyd's bid to expand Pemgarda's EUA for COVID-19 treatment was denied by the FDA. The company will share new data on ...
Invivyd news ‘disappointing’ but not in model, says H.C. Wainwright
H.C. Wainwright maintains a Buy rating on Invivyd (IVVD) with a $10 price target after the FDA rejected its submission to expand Pemgarda’s ...
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FDA won’t al­low In­vivyd’s Pem­gar­da to treat Covid; An­tibi­ot­ic biotech launch­es
FDA denies Invivyd's EUA expansion for Pemgarda in Covid treatment while BioCryst reports positive Orladeyo data. AN2 changes endpoint, OS Therapies seeks partners & Eyenovia restructures.
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This Penny Stock Just Doubled on Clinical Trial Results. Analysts Think It Can Surge 266% From Here.
Biotechnology is a high-risk, high-reward landscape where innovation determines success. Yet, occasionally, a small player flips the script. Invivyd (IVVD), a biomedical firm specializing in ...
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Invivyd, Inc. (IVVD)
Invivyd Inc. (NASDAQ:IVVD) announced that new in vitro neutralization data show continued neutralizing activity of Pemgarda (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 ...
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Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability
PEMGARDA was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for ...