---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-068364"
form_type: "8-K"
ticker: "BCLI"
cik: "0001137883"
company_name: "BRAINSTORM CELL THERAPEUTICS INC."
filed_at: "2023-06-06T23:59:59+00:00"
generated_at: "2026-06-14T06:20:28.176140+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA schedules advisory committee meeting for BrainStorm's NurOwn BLA on Sept 27, 2023

## Summary
- FDA Cellular, Tissue and Gene Therapies Advisory Committee to review NurOwn BLA for ALS on September 27, 2023.
- PDUFA target action date set for December 8, 2023.
- Company states confidence in data supporting regulatory approval and commitment to ALS community.
- BrainStorm notes FDA regulatory flexibility and ongoing work with ALS experts on rigorous clinical study.

## SEC filing metadata
- accession: 0001104659-23-068364
- form_type: 8-K
- ticker: BCLI
- cik: 0001137883
- company_name: BRAINSTORM CELL THERAPEUTICS INC.
- filed_at: 2023-06-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/0001104659-23-068364-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1137883/000110465923068364/tm2317893d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-068364
- JSON: https://secwatch.observer/filing/0001104659-23-068364.json
- Plain text: https://secwatch.observer/filing/0001104659-23-068364.txt

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