Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA's Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain Immunocompromised Patients
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Invivyd, Inc. has submitted an updated immunobridging analysis to the FDA to support an amendment to the EUA for PEMGARDA™ (pemivibart) to treat mild-to-moderate COVID-19 in certain immunocompromised patients. This follows its previous EUA for pre-exposure prophylaxis in March 2024.
January 27, 2025 | 12:15 pm
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Invivyd has submitted new data to the FDA to expand the EUA for PEMGARDA™ to include treatment for mild-to-moderate COVID-19 in certain immunocompromised patients. This could enhance the drug's market potential.
The submission of updated data to the FDA for expanding the EUA of PEMGARDA™ indicates a potential increase in market reach and sales if approved. This is a positive development for Invivyd, suggesting a likely short-term stock price increase.
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