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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.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Brainstorm Cell Therapeutics's position in the market.

Rhea-AI Summary
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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Rhea-AI Summary
BrainStorm Cell Therapeutics Inc. (BCLI) to provide a corporate update on adult stem cell therapeutics for neurodegenerative diseases.
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conferences
Rhea-AI Summary
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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Rhea-AI Summary
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) issued a Letter to Shareholders outlining their commitment to advancing NurOwn as a treatment for ALS patients despite recent challenges in the BLA submission. The company is ambitiously pursuing a Phase 3b trial and exploring funding strategies to align with FDA requirements. They are focused on maintaining their NASDAQ listing status and enhancing the value of their assets to garner market support.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) completed a productive meeting with the FDA to discuss its investigational treatment for ALS, NurOwn. The meeting aimed to outline key considerations for a Special Protocol Assessment for a planned Phase 3b trial, with the goal of securing FDA agreement on protocol design.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the US FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting, scheduled for December 6, 2023, will focus on plans for a Special Protocol Assessment (SPA) for a confirmatory Phase 3 trial in ALS. BrainStorm aims to align with the FDA on protocol design and marketing approval requirements for NurOwn.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced a presentation at the 6th Annual ALS Research Symposium, showcasing new analyses from the NurOwn placebo-controlled Phase 3 ALS trial. The presentation highlights the biological effect of NurOwn through CSF biomarker data, reinforcing the clinical outcomes from the trial. The Phase 3 trial was designed to evaluate the safety and efficacy of repeat doses of NurOwn in 189 ALS participants, with primary endpoints including safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks.
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced its Q3 2023 financial results and corporate update, including a strategic realignment and withdrawal of the BLA for NurOwn in ALS. The company also provided insights into the recent highlights and financial results, and invites participation in a conference call and webcast at 8:30 a.m. Eastern Time today.
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earnings
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BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) will hold a conference call on November 14th to discuss its financial results for the third quarter of 2023 and provide a corporate update. The call will feature the company's President, CEO, and Interim CFO. Participants can submit questions in advance and join the call via webcast or phone. A replay will be available until November 28, 2023.
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Brainstorm Cell Therapeutics, Inc.

Nasdaq:BCLI

BCLI Rankings

BCLI Stock Data

17.58M
42.58M
16.39%
8.1%
4.15%
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