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Brainstorm Cell Therapeutics, Inc. - BCLI STOCK NEWS

Welcome to our dedicated news page for Brainstorm Cell Therapeutics (Ticker: BCLI), a resource for investors and traders seeking the latest updates and insights on Brainstorm Cell Therapeutics.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Brainstorm Cell Therapeutics's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

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BrainStorm Cell Therapeutics Inc. announces management changes with Dr. Bob Dagher promoted to Chief Medical Officer and Dr. Stacy Lindborg stepping down as Co-CEO to join the Board of Directors. The company is preparing for a registrational Phase 3b trial of NurOwn® for ALS, with Dr. Dagher overseeing the trial. The FDA has granted a Special Protocol Assessment for the trial.
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BrainStorm Cell Therapeutics Inc. (BCLI) received a notification from Nasdaq stating that the company has regained compliance with the minimum market value of listed securities requirement. The market value of listed securities has been $35,000,000 or greater for 11 consecutive business days, from March 22, 2024, through April 9, 2024.
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BrainStorm Cell Therapeutics Inc. announced positive Phase 3 biomarker data for NurOwn treatment in ALS. The study shows significant impact on key biomarkers predictive of disease progression, supporting NurOwn's mechanism of action. Treatment led to changes in 64% of analyzed biomarkers, indicating potential benefits for ALS patients.
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BrainStorm Cell Therapeutics Inc. (BCLI) receives FDA agreement for Phase 3b trial of NurOwn in ALS, aiming for regulatory approval. The trial design validation under SPA supports a future BLA. The company plans to commence the study in 2024, focusing on efficacy and safety in ALS patients.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) will hold a conference call on April 9, 2024, to update shareholders on the NurOwn® program. The call will feature key executives discussing the latest developments and answering questions from the investment community.
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BrainStorm Cell Therapeutics Inc. provided a corporate update and financial results for the full year ended December 31, 2023. The company aims to move forward with a Phase 3b trial for NurOwn to potentially support a new Biologics License Application. BrainStorm submitted a Special Protocol Assessment request to the FDA and presented the trial design at a conference. Despite withdrawing the BLA for NurOwn in ALS, the company remains committed to developing the treatment. Financially, the company saw a decrease in cash and an increase in research and development expenses, resulting in a net loss for 2023.
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BrainStorm Cell Therapeutics Inc. announces a planned Phase 3b trial to confirm the efficacy and safety of NurOwn in mild-to-moderate ALS patients. The trial design includes a randomized, double-blind, placebo-controlled period followed by an open-label extension period. BrainStorm has submitted a Special Protocol Assessment request to the FDA for this study.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) submits a Special Protocol Assessment (SPA) request to the FDA for a Phase 3b study of NurOwn®, its ALS treatment. The SPA aims to de-risk regulatory aspects and ensure trial adequacy, with an expected response within 45 days.
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BrainStorm Cell Therapeutics Inc. (BCLI) to provide a corporate update on adult stem cell therapeutics for neurodegenerative diseases.
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Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) has announced the grant and allowance of three patent applications for NurOwn® and NurOwn-Exosomes. The European Patent office granted a patent for a method of qualifying whether a cell population is suitable for treating ALS, as well as claims for an isolated population of mesenchymal stem cells for use in treating ALS. The Australian patent Office granted a patent for an isolated Exosomes population derived from MSC-NTF cells and a pharmaceutical composition for the treatment of neurodegenerative diseases. The Israel Patent Office also announced the allowance of the same claims for application No. 277447 with an Acceptance date on December 01, 2023. Brainstorm's CEO, Chaim Lebovits, emphasized the importance of fortifying their technological advancements with robust intellectual property strategies and highlighted the significance of securing these patents for the future of their proprietary NurOwn technology, particularly for ALS treatment.
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Brainstorm Cell Therapeutics, Inc.

Nasdaq:BCLI

BCLI Rankings

BCLI Stock Data

36.02M
61.21M
12.8%
5.99%
1.97%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
Link
US
New York

About BCLI

brainstorm cell therapeutics inc. (nasdaq:bcli), is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative disorders such as als (lou gehrig's disease), multiple sclerosis (ms) and parkinson’s disease (pd). these diseases have limited treatment options and as such represent unmet medical needs. nurown™ is brainstorm’s proprietary process for the propagation and differentiation of adult, autologous mesenchymal stem cells (msc) into neurotrophic factor (ntf)-secreting cells, and the transplantation of these specialized cells at or near the affected tissue site. our platform technology essentially converts mscs into living drug delivery system for ntfs. we have obtained proof-of-concept in a variety of animal models of neurodegenerative diseases, including parkinson's, huntington's, als, ms, and peripheral nerve injury. we have completed two single-arm clinical trials in als patients, conducted in israel, which have demonstr