BrainStorm Cell Therapeutics Inc.
Tel Aviv
455 articles about BrainStorm Cell Therapeutics Inc.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.
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BrainStorm Cell Therapeutics to Unveil Phase 3b NurOwn® Trial Design at MDA Clinical and Scientific Conference
2/27/2024
BrainStorm Cell Therapeutics Inc. announced that it will present a poster outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis at the MDA Clinical and Scientific Conference, on Monday, March 4 between 6-8 p.m. at the Hilton Orlando Hotel, Florida.
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BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn® in ALS
2/23/2024
BrainStorm Cell Therapeutics Inc. announced that it has submitted a Special Protocol Assessment request to the U.S. Food and Drug Administration for a Phase 3b study of NurOwn®, its investigational treatment for amyotrophic lateral sclerosis.
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BrainStorm Cell Therapeutics to Present at European Life Sciences CEO Forum
2/13/2024
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will provide a corporate update at the 17th Annual European Life Sciences CEO Forum to take place 28 - 29 of February, 2024 in Zurich, Switzerland.
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BrainStorm Granted Patents for Allogeneic Exosome Platform-Product in Neurological Disorder Treatments
12/26/2023
Brainstorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, provided an update on the grant and allowance of three patent applications for NurOwn® and NurOwn-Exosomes.
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BrainStorm Issues 2023 Letter to Shareholders
12/20/2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, issued a Letter to shareholders.
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BrainStorm Cell Therapeutics Announces Outcome of FDA Meeting on NurOwn® in ALS
12/7/2023
BrainStorm Cell Therapeutics Inc. today announced the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn®, its investigational treatment for amyotrophic lateral sclerosis (ALS).
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BrainStorm Cell Therapeutics Announces In-Person Meeting with the FDA to Discuss Confirmatory Phase 3 Trial for NurOwn® in ALS
11/20/2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the US Food & Drug Administration has granted the company a meeting to discuss the regulatory path forward for NurOwn® in amyotrophic lateral sclerosis.
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BrainStorm Cell Therapeutics to Present at 6th Annual ALS Research Symposia
11/17/2023
BrainStorm Cell Therapeutics Inc. today announced a podium presentation and panel discussion at the 6th Annual ALS Research Symposium hosted by ALS ONE.
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BrainStorm Cell Therapeutics Announces Third quarter 2023 Financial Results and Provides Corporate Update
11/14/2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced financial results for the third quarter ended September 30, 2023 and provided a corporate update.
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BrainStorm to Announce Third Quarter 2023 Financial Results and Provide a Corporate Update
11/7/2023
BrainStorm Cell Therapeutics Inc. announced that it will hold a conference call on Tuesday, November 14th at 8:30 a.m. Eastern Time to discuss its financial results for the third quarter ended September 30, 2023 and provide a corporate update.
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BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn® for the Treatment of ALS
10/24/2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced a strategic realignment to enable accelerated development of NurOwn® for the treatment of amyotrophic lateral sclerosis.
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BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS
10/18/2023
BrainStorm Cell Therapeutics Inc. announced that the US Food and Drug Administration has invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis.
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After an FDA advisory committee voted 17-1 against approving NurOwn last month, BrainStorm executives Wednesday laid out a potential path forward for the experimental amyotrophic lateral sclerosis treatment.
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An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.
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BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
9/28/2023
BrainStorm Cell Therapeutics Inc. announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application for NurOwn®, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis.
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BrainStorm Cell Therapeutics Stock Trading Halted Today
9/27/2023
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that Nasdaq has halted trading of the Company's common stock.
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Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.
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The FDA’s briefing documents found that BrainStorm's BLA submission for its investigational cell therapy for ALS did not demonstrate evidence of effectiveness and that the manufacturing data was “grossly deficient.”