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NurOwn® (debamestrocel)

Amyotrophic Lateral Sclerosis (ALS)

Phase 3bActive; FDA Special Protocol Assessment (SPA) agreed

Key Facts

Indication

Amyotrophic Lateral Sclerosis (ALS)

Phase

Phase 3b

Status

Active; FDA Special Protocol Assessment (SPA) agreed

Company

BrainStorm Cell Therapeutics

About BrainStorm Cell Therapeutics

BrainStorm Cell Therapeutics is a clinical-stage biotechnology company singularly focused on defeating neurodegenerative diseases through its innovative NurOwn® autologous cellular therapy platform. Its most advanced program targets Amyotrophic Lateral Sclerosis (ALS), where it has secured a Special Protocol Assessment (SPA) with the FDA for a confirmatory Phase 3b trial following mixed but promising biomarker data from its prior Phase 3 study. The company's strategy hinges on validating NurOwn's multimodal mechanism of action in ALS to secure regulatory approval, while leveraging the platform's potential for expansion into other neurodegenerative indications with high unmet need.

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Therapeutic Areas

Neurodegenerative Diseases Amyotrophic Lateral Sclerosis

Other Amyotrophic Lateral Sclerosis (ALS) Drugs

Drug	Company	Phase	Status
NPT520-34	Neuropore Therapies	Pre-clinical/Phase 1	Partnered (Biogen), Active
NUZ-001	Neurizon Therapeutics	Phase 2/3 (Platform Trial)	Active
CNM-Au8	Clene	Phase 2/3	Active
Masitinib	AB Science	Phase 3	Active
Undisclosed Program	Zhimeng Biopharma	Clinical	Active
SLS-005	Seelos Therapeutics	Platform Trial	Active (HEALEY ALS Platform Trial – Regimen E)
PMN442	ProMIS Neurosciences	Preclinical	Active
nAV-101	nVector	Pre-clinical	Active
ALTA-808	Alteron Therapeutics	Preclinical	IND-enabling studies launching
GM6	Genervon Biopharmaceuticals	Phase 2	Active
Lou Gehrig’s disease	Genclis	Discovery	Active
Treg-directed therapy for ALS	Iltoo Pharma	Pre-clinical	Active