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 Have No Alternative Therapeutic Options; No Change to the Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients
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The FDA declined Invivyd's request to expand the EUA of PEMGARDA™ for treating mild-to-moderate COVID-19 in immunocompromised individuals. The existing EUA for pre-exposure prophylaxis remains unchanged.
February 24, 2025 | 12:30 pm
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NEGATIVE IMPACT
The FDA's decision to decline the expansion of PEMGARDA™'s EUA for treatment purposes may limit Invivyd's market potential for this drug. However, the existing EUA for pre-exposure prophylaxis remains unchanged.
The FDA's refusal to expand the EUA limits the potential market for PEMGARDA™ as a treatment option, which could negatively impact Invivyd's stock. The existing EUA for pre-exposure prophylaxis remains, but the inability to expand usage could be seen as a setback.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100