Invivyd gets FDA EUA for PEMGARDA as COVID-19 PrEP for immunocompromised; cash $200.6M

Invivyd, Inc.

FDA issued EUA for PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19 in adults/adolescents (≥12 yrs, ≥40 kg) with moderate-to-severe immune compromise.
Estimated cash and cash equivalents of $200.6M as of Dec 31, 2023 (preliminary, unaudited).
In Feb 2024, raised $40.5M gross proceeds from ATM share sales, strengthening balance sheet ahead of launch.
Immunobridging established: Day 28 calculated sVNA titer vs JN.1 was 7365 (90% CI: 7148–7589); ratio to reference 0.82 (0.80–0.85).
Anaphylaxis observed in 0.6% (4/623) of CANOPY participants; boxed warning and two-hour post-infusion monitoring required.

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