secwatch.observer — SEC 8-K summary
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Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2024-03-25T23:59:59+00:00
Accession:  0001193125-24-075582
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/0001193125-24-075582-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000119312524075582/d801617d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-075582

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer