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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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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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BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn
4/16/2024
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer.
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Experts are hopeful that objective biomarker measures for amyotrophic lateral sclerosis, such as the ones being developed by EverythingALS, will lead to more targeted, effective treatments.
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BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value Rule - April 11, 2024
4/11/2024
BrainStorm Cell Therapeutics Inc. announced that it received a notification letter on April 10, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market, indicating that the Company has regained compliance with the minimum market value of listed securities requirement set forth under Nasdaq Listing Rule 5550.
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BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS
4/10/2024
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced the peer-reviewed publication of Phase 3 biomarker data in Muscle and Nerve.
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After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.
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BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS
4/9/2024
BrainStorm Cell Therapeutics Inc. announced that it received written agreement from the U.S. Food and Drug Administration, under a Special Protocol Assessment, on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis.
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BrainStorm Cell Therapeutics to Provide Update on NurOwn Program
4/8/2024
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced that it will hold a conference call to update shareholders on the NurOwn® program tomorrow, April 9, at 8:00 AM Eastern Time.
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BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update
4/1/2024
BrainStorm Cell Therapeutics Inc. today announced financial results for the full year ended December 31, 2023 and provided a corporate update.
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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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Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.
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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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5 FDA Decisions to Watch in Q1
1/2/2024
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA's docket this quarter. -
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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Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
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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).