secwatch.observer — SEC 8-K summary
======================================

Issuer:     CERUS CORP (CERS)
CIK:        0001020214
Form:       8-K
Filed at:   2024-10-16T23:59:59+00:00
Accession:  0001193125-24-238169
Event type: other_material
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cerus gets $248M BARDA contract for RBC program; EU CE Mark review denied
-------------------------------------------------------------------------

- New BARDA contract valued up to $248M to support U.S. INTERCEPT RBC system development and PMA submission; $32.1M awarded for base period.
- CE Mark review in Europe closed without approval due to insufficient impurity profile data; company assessing strategy for future filing.
- RedeS Phase 3 trial enrolling at two new sites; timing of completion and PMA submission under assessment due to later-than-expected site activation.
- Company believes positive ReCePI trial data could support broader indication in a future EU CE Mark submission.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1020214/000119312524238169/0001193125-24-238169-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1020214/000119312524238169/d856042d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-238169

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