BrainStorm Cell Therapeutics Aligns with FDA on Phase 3b NurOwn Clinical Trial CMC Aspects
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, has reached an important milestone by aligning with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b clinical trial for NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS). This […]
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 […]
I Am ALS and Veterans with ALS send an Open Letter to FDA Requesting an Advisory Committee Meeting to Discuss NurOwn
WASHINGTON, Nov. 23, 2022 /PRNewswire/ — To the Honorable Dr. Robert Califf and Dr. Peter Marks: We represent Veterans with ALS who support Brainstorm Cell Therapeutics’ request for the FDA to hold a public Advisory Committee meeting (“AdCom”) to engage in scientific discourse about the “clinically meaningful” evidence supporting FDA’s approval of a mesenchymal stem cell therapy, NurOwn. When we […]
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 […]