BioSpace4h
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 ...
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, 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 ...
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 ...
Healthline12d
Pemgarda Side Effects and Tips for Managing Them
Pemgarda (pemivibart) can cause side effects that range from mild to serious. More common side effects include fatigue and infusion-related reactions. If side effects become difficult to tolerate ...
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 ...
Why Invivyd, Inc. (IVVD) Is Soaring This Year So Far
We recently compiled a list of the 10 Micro and Small-Cap Firms Drive Year-to-Date Gains. In this article, we are going to ...
Nasdaq28d
Invivyd Submits Updated Immunobridging Data To FDA For PEMGARDA EUA Amendment
(RTTNews) - Invivyd, Inc. (IVVD), a biopharmaceutical company, on Monday announced the submission of an updated immunobridging analysis to the U.S. Food and Drug Administration or FDA in support ...
manilatimes22d
Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability
Preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, 48% growth over Q3 2024 net product revenue of $9.3 million Preliminary Q4 2024 total operating costs and expenses of ...
Nasdaq21d
Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability
Based on currently available information, the company is announcing preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of $13.8 million, representing a 48% increase over Q3 2024 net ...