Investors
BrainStorm Cell Therapeutics is a clinical-stage biotechnology company focused on the development of best-in-class autologous cellular therapeutics for the treatment of highly debilitating neurodegenerative diseases.
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OTCQB: BCLI
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Clinical development
ALS program status
Phase 3 (NCT03280056), completed. Generally well tolerated. The primary endpoint was not met; however a pre-specified analysis of participants with baseline ALSFRS-R ≥ 35 showed a clinical response at 28 weeks. Significant improvements in CSF biomarkers of neuroinflammation, neurodegeneration and neurotrophic support were observed, with placebo unchanged.
Phase 3b protocol under Special Protocol Assessment
The Phase 3b protocol and statistical analysis plan hold a Special Protocol Assessment - adequate to support a future BLA in ALS.
Pre-specified Phase 3 subgroup
Phase 3 pre-specified analysis of participants with baseline ALSFRS-R ≥ 35 showed a clinical response at 28 weeks; that population is the Phase 3b entry criterion.
CSF biomarker findings
Significant CSF improvements in neuroinflammation, neurodegeneration and neurotrophic support, with placebo unchanged.
Other MSC-NTF programs
The same MSC-NTF platform supports progressive MS (Phase 2 complete) and preclinical work in Huntington’s, Parkinson’s and ASD.
ALS program
Program milestones
FDA SPA agreement on Phase 3b design
Announced April 2024
Longer-term biomarker data presented
Announced May 2024
Phase 3b trial initiation
Planned under the SPA agreement
Part A 24-week readout
ALSFRS-R change from baseline; CAFS inference
News releases
All news releases- BrainStorm Cell Therapeutics Announces Second Quarter 2026 Financial Results and Provides Corporate Update
- BrainStorm Appoints Former FDA Associate Commissioner Peter J. Pitts as Executive Chairman
- BrainStorm Cell Therapeutics Announces Publication Calling for Updated FDA Approaches to ALS, Rare Diseases and Regenerative Medicine
Research
Analyst coverage
- Maxim Group
- Jason McCarthy
- Zacks Small-Cap Research
- David Bautz
- Dawson James Securities
- Jason Kolbert
Analysts’ views and forecasts are their own, not BrainStorm’s.
BrainStorm's autologous MSC-NTF cell therapy (NurOwn®, debamestrocel) is investigational and has not been approved by the FDA or any other regulatory authority.