FDA Rejects Invivyd's Request To Expand Emergency Authorization For Preventive COVID-19 Antibody For Immunocompromised Patients

1. FDA declined IVVD's EUA expansion for pemivibart in mild-to-moderate COVID-19 cases. The decision affects immune-compromised adult and adolescent patients. 2. Existing EUA for Pemgarda remains active for selected immunocompromised patients. The treatment opportunity was not included in current financial guidance. 3. FDA requires superior antiviral activity in immunobridging analysis for expanded EUA. The agency stated current analyses do not meet its benefit-risk criteria. 4. New data from Phase 1/2 VYD2311 trials indicate improved serum concentration and half-life over pemivibart. This could influence future regulatory submissions. 5. IVVD stock dropped 29.9% to $1.24 premarket following FDA's decision. The negative market reaction underscores investor concerns.