Revolutionizing ALS Treatment: BrainStorm’s Phase 3b Trial Moves Forward with FDA Approval
BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapeutics for neurodegenerative diseases, has achieved a significant milestone with the FDA’s agreement on a Special Protocol Assessment (SPA) for its Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). This agreement marks a critical step in advancing the potential treatment to the market, […]
BrainStorm Cell Therapeutics Advances ALS Treatment with Phase 3b Trial of NurOwn®
In a significant stride towards combating neurodegenerative diseases, BrainStorm Cell Therapeutics Inc. has announced its submission of a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn®, its pioneering investigational treatment for amyotrophic lateral sclerosis (ALS). This move, following a constructive in-person meeting with […]
BrainStorm Cell Therapeutics Announces Key FDA Meeting for ALS Treatment
BrainStorm Cell Therapeutics Inc., a prominent developer of adult stem cell therapies for neurodegenerative diseases, has announced a significant development in their pursuit of treating amyotrophic lateral sclerosis (ALS). The company has secured an in-person meeting with the U.S. Food & Drug Administration (FDA), scheduled for December 6, 2023. This meeting is a critical step […]
NurOwn: Revolutionizing ALS Treatment with Biomarkers
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has presented new biomarker data from the Phase 3 trial of its late-stage investigational ALS treatment, NurOwn, at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. The data showed that treatment with NurOwn significantly elevated markers of […]
BrainStorm Cell Therapeutics Partners with NEALS, The ALS Association, and I AM ALS to Provide Public Access to Biospecimens from NurOwn’s Phase 3 ALS Study
NEW YORK, Jan. 10, 2023 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that BCLI will donate biospecimens from NurOwn’s placebo-controlled Phase 3 ALS trial to the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) biorepository for use by the research community. The specimens are being submitted to the […]
BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®
NEW YORK, Dec. 27, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application […]
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
NEW YORK, Nov. 10, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The […]
BrainStorm to Announce Second Quarter Results and Provide a Corporate Update
NEW YORK, Aug. 1, 2022 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that it will hold a conference call to update shareholders on financial results for the second quarter, ended on June 30, 2022, and provide a corporate update, at 8:00 a.m. Eastern […]