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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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An FDA advisory committee voted 17-1 on Wednesday that BrainStorm Cell Therapeutics did not demonstrate substantial evidence of efficacy for NurOwn in mild to moderate 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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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.”
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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 will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
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As the new executive VP and chief development officer of BrainStorm, Dagher is tasked with securing FDA approval of NurOwn for the treatment of ALS.
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BrainStorm Cell Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update
8/14/2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.
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BrainStorm to Announce Second Quarter 2023 Financial Results and Provide a Corporate Update
8/7/2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced today that it will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2023, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, August 14th.
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The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
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BioSpace rounded up companies with products for Alzheimer’s, ALS, Parkinson’s and Huntington’s in the final stages of clinical testing.
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Brainstorm Cell Therapeutics Announces Pricing of $7.5 Million Registered Direct Offering
7/17/2023
BrainStorm Cell Therapeutics Inc. today announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 4,054,055 shares of the Company's common stock and warrants to purchase up to an aggregate of 4,054,055 shares of common stock in a registered direct offering.
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BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer
7/12/2023
BrainStorm Cell Therapeutics Inc. today announced the appointment of Bob Dagher , MD, as Executive Vice President and Chief Development Officer effective July 17, 2023.
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After its Biologics License Application was rejected by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.
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BrainStorm Cell Therapeutics Data Show Treatment with NurOwn Significantly Reduces NfL, a Key Biomarker of Neurodegeneration
7/7/2023
BrainStorm Cell Therapeutics Inc. this week 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.
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After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
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The majority of ALS patients are excluded from clinical trials. Experts say using biomarkers and stratifying trial populations can expand eligibility and provide additional scientific insights.
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BrainStorm Cell Therapeutics Appoints Nir Naor as Board Member and Audit Committee Chair
6/20/2023
BrainStorm Cell Therapeutics Inc. today announced the appointment of Nir Naor, CPA, CFA, MBA (IMD), LL.M, as Board Member, chairman of its Audit Committee and member of its Governance, Nomination and Compensation Committee.
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BrainStorm Cell Therapeutics to Participate in the Maxim Group Healthcare Virtual Conference
6/16/2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) today announced that Dr. Stacy Lindborg, Co-Chief Executive Officer, and Chaim Lebovits, President and Chief Executive Officer, will participate in a fireside chat at the Maxim Group Healthcare Virtual Conference on Wednesday, June 21, 2023 at 9:00 a.m. Eastern Time.
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BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review NurOwn® Biologics License Application Scheduled for September 27, 2023
6/6/2023
BrainStorm Cell Therapeutics Inc. announced that the U.S. Food and Drug Administration will convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the Biologics License Application for NurOwn®, its investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis.