Amyotrophic lateral sclerosis, Neurodegenerative disease

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm is also conducting an FDA-approved Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter 2021.

Drug & Indication	Stage & Event	Catalyst Date
NurOwn (autologous MSC-NTF) Details Amyotrophic lateral sclerosis, Neurodegenerative disease Big Mover™ Suspected Mover™ Susp. Mover™	PDUFA Adcomm	Some catalyst date You must sign up to see the catalyst details. You must sign up to see the catalyst details. You must sign up to see the catalyst details. You must sign up to see the catalyst details.Sign up now.
NurOwn (autologous MSC-NTF) Details Multiple sclerosis	Failed Discontinued	Some catalyst date You must sign up to see the catalyst details. You must sign up to see the catalyst details. You must sign up to see the catalyst details. You must sign up to see the catalyst details.Sign up now.

Drug Pipeline

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