secwatch.observer — SEC 8-K summary
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Issuer:     BRAINSTORM CELL THERAPEUTICS INC. (BCLI)
CIK:        0001137883
Form:       8-K
Filed at:   2024-04-09T23:59:59+00:00
Accession:  0001104659-24-044928
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BrainStorm announces FDA SPA agreement for Phase 3b trial of NurOwn in ALS
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- FDA agreed on Phase 3b trial design under Special Protocol Assessment (SPA) for NurOwn in ALS.
- Phase 3b trial (BCT-006-US) to enroll ~200 patients, double-blind placebo-controlled Part A (24 weeks) then open-label Part B.
- Primary endpoint: change in ALSFRS-R total score at Week 24; CAFS to account for mortality.
- Company expects trial commencement in 2024 after investigator and IRB approvals.
- SPA validates protocol adequacy for supporting a future Biologics License Application (BLA).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1137883/000110465924044928/0001104659-24-044928-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1137883/000110465924044928/tm2411382d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-044928

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