secwatch.observer — SEC 8-K summary
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Issuer:     CERUS CORP (CERS)
CIK:        0001020214
Form:       8-K
Filed at:   2024-03-19T23:59:59+00:00
Accession:  0000950170-24-033155
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cerus INTERCEPT RBC Phase 3 trial meets primary non-inferiority endpoint
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- AKI incidence 29.3% (INTERCEPT RBC) vs 28.0% (conventional); non-inferiority margin 14% (p=0.001).
- Related TEAEs within 28 days: 2.5% vs 0.6% (p=0.130); no adverse health effects from RBC antibodies.
- Modular PMA submission to FDA planned H2 2025; final module expected H2 2026 after RedeS trial.
- ReCePI trial enrolled 581 patients at 18 U.S. sites; funded in part by BARDA contract.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1020214/000095017024033155/0000950170-24-033155-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1020214/000095017024033155/cers-20240319.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-033155

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