---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-075146"
form_type: "8-K"
ticker: "BCLI"
cik: "0001137883"
company_name: "BRAINSTORM CELL THERAPEUTICS INC."
filed_at: "2024-06-26T23:59:59+00:00"
generated_at: "2026-06-01T01:19:59.323020+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# BrainStorm reaches alignment with FDA on CMC for NurOwn Phase 3b ALS trial

## Summary
- FDA alignment on Chemistry, Manufacturing, and Controls (CMC) for Phase 3b trial of NurOwn for ALS.
- Follows April 2024 Special Protocol Assessment (SPA) agreement de-risking trial design and endpoints.
- CEO Chaim Lebovits says all previously outstanding CMC questions resolved.
- Company moves forward with pivotal Phase 3b trial aiming for NurOwn approval.

## SEC filing metadata
- accession: 0001104659-24-075146
- form_type: 8-K
- ticker: BCLI
- cik: 0001137883
- company_name: BRAINSTORM CELL THERAPEUTICS INC.
- filed_at: 2024-06-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1137883/000110465924075146/0001104659-24-075146-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1137883/000110465924075146/tm2418335d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-075146
- JSON: https://secwatch.observer/filing/0001104659-24-075146.json
- Plain text: https://secwatch.observer/filing/0001104659-24-075146.txt

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