---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-050441"
form_type: "8-K"
ticker: "BCLI"
cik: "0001137883"
company_name: "BRAINSTORM CELL THERAPEUTICS INC."
filed_at: "2025-05-19T23:59:59+00:00"
generated_at: "2026-05-21T01:15:21.386606+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BrainStorm receives FDA clearance to initiate Phase 3b trial of NurOwn for ALS

## Summary
- FDA cleared Phase 3b trial under Special Protocol Assessment (SPA); endpoints agreed for future BLA.
- Trial to enroll ~200 participants at academic centers; 24-week double-blind phase plus 24-week open-label extension.
- Primary endpoint: change from baseline to week 24 on ALS Functional Rating Scale-Revised (ALSFRS-R).
- Company plans to activate sites in phases and secure funding via non-dilutive grants.
- Investor call and webcast scheduled for May 19 at 8:30 a.m. ET.

## SEC filing metadata
- accession: 0001104659-25-050441
- form_type: 8-K
- ticker: BCLI
- cik: 0001137883
- company_name: BRAINSTORM CELL THERAPEUTICS INC.
- filed_at: 2025-05-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1137883/000110465925050441/0001104659-25-050441-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1137883/000110465925050441/tm2515509d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-050441
- JSON: https://secwatch.observer/filing/0001104659-25-050441.json
- Plain text: https://secwatch.observer/filing/0001104659-25-050441.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.