BrainStorm Cell Therapeutics Inc.
Tel Aviv
424 articles about BrainStorm Cell Therapeutics Inc.
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BrainStorm Announces High-Level FDA Feedback on NurOwn® ALS Clinical Development Program
2/22/2021
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase 3 clinical trial.
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The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.
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BrainStorm Announces Feedback from FDA Type-C Meeting on Future NurOwn® Manufacturing Plan
2/9/2021
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) to review specific aspects of the company's planned manufacturing modifications to support the development of a semi-automated commercial manufacturing process for NurOwn
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BrainStorm Announces Full Year 2020 Financial Results and Provides a Corporate Update
2/4/2021
Company met with the FDA to present phase 3 data and is in ongoing discussions with the FDA to identify agreed upon regulatory pathways that may support NurOwn's future approval in ALS
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BrainStorm-Cell Therapeutics to Announce Fourth Quarter and Fiscal Year 2020 Financial Results and Provide a Corporate Update
1/28/2021
-BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and year ended December 31, 2020
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BrainStorm Announces the Publication of Preclinical Data Highlighting the Potential of a NurOwn® Derived Exosome-Based Treatment for COVID-19 ARDS
1/20/2021
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the peer-reviewed publication of a preclinical study in the journal Stem Cell and Research Therapy.
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BrainStorm Issues 2020 Letter to Shareholders
12/28/2020
BrainStorm Cell Therapeutics Inc., a leading developer of cellular therapies for neurodegenerative diseases, announced the following letter from its Chief Executive Officer, Chaim Lebovits, to its shareholders and the investment community.
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BrainStorm Announces Completion of All Dosing in NurOwn® Phase 2 MS Study
12/18/2020
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that all dosing has been completed in the ongoing Phase 2 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for progressive MS.
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BrainStorm Announces NurOwn® Expanded Access Program
12/14/2020
NurOwn® will be made available for ALS patients who completed all Phase 3 clinical trial assessments and meet specific eligibility criteria
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BrainStorm to present NurOwn® Phase 3 Clinical Trial Results at 31st International Symposium on ALS/MND
11/23/2020
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that results from the Company's placebo controlled, randomized, double-blind Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS will be presented as an oral presentation at the 31st International Symposium on ALS/MND to be held as a virtual symposium Dec 9-11th, 2020.
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BrainStorm Announces Topline Results from NurOwn® Phase 3 ALS Study
11/17/2020
Clinical trial did not meet statistical significance in primary efficacy endpoint NurOwn® showed a clinically meaningful treatment response compared to placebo in a pre-specified subgroup CSF biomarker analyses confirmed NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers Company management to host conference call and live webcast today at 8:30 AM ET
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A Phase III trial of NurOwn® (MSC-NTF cells), BrainStorm Cell Therapeutics’ investigational therapy for amyotrophic lateral sclerosis, did not find a statistically significant difference between the therapy and placebo for improving scores on a revised ALS functional rating scale.
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Rapid Reshore & Development and BrainStorm Cell Therapeutics Announce Agreement to Advance Construction of BrainStorm's U.S. Manufacturing Facility
10/26/2020
Rapid Reshore & Development and BrainStorm Cell Therapeutics, Inc announced that BrainStorm has selected RR&D as its partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn® in the U.S.
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BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Outcomes at the Virtual New York Stem Cell Foundation Conference
10/19/2020
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "MSC-NTF Exosomes: A Novel Therapeutic Modality in the Mouse LPS-induced ARDS model Analysis" at the NYSCF Conference Meeting, being held virtually.
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BrainStorm Announces Financial Results for the Third Quarter of 2020 and Provides a Corporate Update
10/15/2020
New senior executives strengthen regulatory and market access capabilities as the Company prepares to transition to a commercial organization
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BrainStorm to Present at the 2020 Cell & Gene Meeting on the Mesa
10/12/2020
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapies for neurodegenerative diseases, announced Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the 2020 Cell & Gene Meeting on the Mesa, being held virtually October 12-16, 2020.
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BrainStorm Announces Scientific Presentation at the Annual NEALS Meeting
9/30/2020
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS Meeting, being held virtually.
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BrainStorm Appoints William K. White as Senior Vice President, Head of Market Access & Pricing
9/29/2020
Company continues building its executive team and commercial capabilities prior to ALS Phase 3 clinical trial completion and topline data readout in Q4 2020
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BrainStorm to Present at Scientific Conferences in September
9/3/2020
Advanced Therapies & Expo 2020 on September 9 CIRM 2020 Grantee Meeting on September 14 Collaborations That Transform MS Webinar on September 24 NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it will deliver virtual presentations during Advanced Therapies & Expo 2020, September 9, at the 2020 CIRM Grantee Meeting, September 14,
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BrainStorm Appoints Pharmaceutical Veteran Anthony Waclawski as Executive Vice President, Global Head of Regulatory Affairs
9/2/2020
Company plans to further strengthen its regulatory expertise and capabilities as ALS phase 3 clinical trial nears completion in Q4