Welcome to our dedicated page for Brainstorm Cell Therapeutics news (Ticker: BCLI), a resource for investors and traders seeking the latest updates and insights on Brainstorm Cell Therapeutics stock.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a pioneering biotechnology company focused on developing advanced autologous stem cell therapies aimed at treating severe neurodegenerative disorders. These include highly debilitating diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson’s Disease (PD), which currently have limited treatment options.
The cornerstone of Brainstorm's innovative approach is its NurOwn® technology platform. This proprietary technology involves the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into neurotrophic factor (NTF) secreting cells. These MSC-NTF cells are then transplanted at or near the damaged tissue sites, essentially converting MSCs into a living drug delivery system for NTFs that can target specific neurodegenerative diseases.
Brainstorm has demonstrated proof-of-concept in various animal models for diseases including ALS, MS, Parkinson's, Huntington's, and peripheral nerve injuries. The company's commitment to ALS treatment is underscored by the completion of multiple clinical trials, including a Phase 3 trial, which investigated the safety and efficacy of repeat administration of MSC-NTF cells, supported by grants from the California Institute for Regenerative Medicine (CIRM) and the ALS Association.
Most recently, Brainstorm achieved a significant milestone by securing a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the design of a Phase 3b trial of NurOwn in ALS patients. This agreement with the FDA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA) for ALS. The Phase 3b trial aims to enroll up to 200 participants and will involve a double-blind, placebo-controlled period followed by an open-label extension period, focusing on patients earlier in the course of ALS.
Additionally, Brainstorm has fortified its intellectual property portfolio with new patents granted in Europe, Australia, and Israel, enhancing its capability to forge global commercial partnerships for NurOwn. The company's efforts in preclinical research, rigorous clinical trials, and strong collaboration with regulatory agencies and the ALS community underscore its dedication to bringing novel treatment options to patients in need.
Brainstorm's financial condition remains robust, supported by diverse grants and collaborative efforts with advocacy groups. The company continues to advance its pipeline with ongoing clinical trials for progressive MS and plans to expand its research into other neurodegenerative conditions.
For the latest updates on Brainstorm Cell Therapeutics Inc. and its groundbreaking developments, visit their official website or follow their news releases.
BrainStorm Cell Therapeutics has appointed Kirk Taylor, M.D. as the new Executive Vice President and Chief Medical Officer, effective May 1, 2023. Dr. Taylor brings over 26 years of biopharma experience, especially in neurology, and will lead global medical affairs and product launches for the company’s innovative therapeutics, particularly NurOwn, aimed at treating ALS. The appointment is viewed as a strategic move to bolster the company's capabilities in anticipation of regulatory review and growth. BrainStorm is preparing for an FDA Advisory Committee meeting regarding NurOwn, underlining its commitment to advancing treatment options for ALS patients. Dr. Taylor’s background includes leadership roles in major pharmaceutical firms, enhancing BrainStorm’s potential for commercial success and regulatory engagement.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced its financial results for FY 2022, reporting a net loss of approximately $24.3 million and cash reserves of $3 million as of December 31, 2022. The company is prioritizing its Biologics License Application (BLA) for NurOwn® for ALS treatment, with an upcoming FDA Advisory Committee Meeting (ADCOM). Previous challenges led to a Refusal to File; however, the FDA plans to review the amended BLA following ongoing discussions. Key presentations at scientific conferences have shown significant clinical benefits of NurOwn, particularly concerning the ALSFRS-R floor effect.
BrainStorm Cell Therapeutics (BCLI) announced that the FDA will hold an Advisory Committee Meeting (ADCOM) to discuss the Biologics License Application (BLA) for NurOwn, aimed at treating amyotrophic lateral sclerosis (ALS). To expedite this process, BrainStorm requested the FDA's File Over Protest pathway and submitted an amendment to the BLA addressing earlier questions from the FDA. The ADCOM will provide a platform for evaluating the clinical evidence supporting NurOwn, which has been highly anticipated by the ALS community. BrainStorm emphasizes the urgent need for new ALS treatment options.
FAQ
What is the current stock price of Brainstorm Cell Therapeutics (BCLI)?
What is the market cap of Brainstorm Cell Therapeutics (BCLI)?
What is Brainstorm Cell Therapeutics Inc.?
What is NurOwn® technology?
What are the recent achievements of Brainstorm Cell Therapeutics?
What is the Special Protocol Assessment (SPA) from the FDA?
Which diseases are targeted by Brainstorm's therapies?
What phase are Brainstorm's clinical trials in?
How is Brainstorm Cell Therapeutics funded?
What is the significance of the new patents obtained by Brainstorm?
How does NurOwn® work?
Where can I find the latest news on Brainstorm Cell Therapeutics?
