IVVD | Market Cap: $232.0M (07/13/26)
Industry:
Pharma & Biotech

DESCRIPTION

Invivyd is a clinical-stage biopharmaceutical company developing monoclonal antibody (mAb) therapies to prevent and treat viral infectious diseases, primarily COVID-19. Invivyd's only commercial product is PEMGARDA (pemivibart), which received FDA Emergency Use Authorization in March 2024 for pre-exposure prophylaxis of COVID-19 in immunocompromised adults and adolescents — a population for whom COVID-19 vaccines are largely ineffective. PEMGARDA delivers passive immune protection by providing neutralizing antibodies directly, rather than stimulating the immune system to produce them. The product is administered via IV infusion at clinics and infusion centers, and Invivyd sells through three specialty distributors plus a small number of direct accounts, supported by an in-house sales force targeting hematologists, oncologists, and transplant specialists. Invivyd's key pipeline asset is VYD2311, a next-generation COVID-19 prevention mAb engineered from the same antibody backbone as PEMGARDA but with improved potency and an intramuscular injection route, which could enable far broader use beyond infusion centers. A Phase 3 trial is underway, with top-line data expected in mid-2026. Invivyd also has early-stage programs targeting RSV prevention in neonates and children, and measles. The company outsources all manufacturing to WuXi Biologics and relies on CROs for clinical activities. Invivyd is pre-profitability, and its near-term outlook hinges on PEMGARDA maintaining its EUA status and the Phase 3 readout for VYD2311.

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