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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 (NASDAQ: BCLI) announced that Dr. Stacy Lindborg will present at the 2021 Cell & Gene Meeting on the Mesa, scheduled for October 12-14 and October 19-20. The presentation will focus on the expansion of BrainStorm's technology portfolio, emphasizing autologous and allogeneic candidates for neurological diseases, particularly the completed phase 3 trial of NurOwn® for ALS. The webinar will be available on-demand from October 12. The conference will feature numerous presentations on advancements in cell and gene therapy.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific abstract on its Phase 2 study of NurOwn® cells for progressive multiple sclerosis at the 37th ECTRIMS Congress. The trial met its primary endpoint of safety and tolerability, with positive results in neurologic function and cognition. The presentation will occur on October 14, 2021, featuring Dr. Jeffrey Cohen from the Cleveland Clinic. CEO Chaim Lebovits and CMO Ralph Kern emphasized the importance of these findings for advancing therapies for progressive MS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its financial results for the first quarter ended June 30, 2021, indicating a net loss of approximately $6.3 million, down from $7.4 million the previous year. Cash and equivalents totaled around $35.0 million, a decline from $40.0 million as of March 31, 2021. The company successfully received GMP approval for expanded manufacturing capacity in Israel and has strengthened its NurOwn® intellectual property with multiple patents in key markets. Ongoing discussions with ALS experts aim to enhance the regulatory strategy for NurOwn.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received GMP approval from the Israel Ministry of Health for three advanced cleanrooms at Sourasky Hospital, doubling its manufacturing capacity for NurOwn®. This expansion is crucial for supplying ALS patients in Israel and Europe, addressing an urgent need for new therapies. The company remains committed to advancing its cellular technology for neurodegenerative diseases, with ongoing discussions on regulatory pathways for NurOwn®.
BrainStorm Cell Therapeutics (BCLI) will conduct a conference call on August 5, 2021, at 8:00 a.m. ET, to discuss second-quarter financial results ending June 30, 2021, and provide a corporate update. CEO Chaim Lebovits will lead the call, supported by key executives, and encourage shareholders to submit questions by August 4, 2021.
This call aims to enhance transparency with investors and will be accessible via dial-in numbers and a webcast link.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the grant and allowance of several patents for its NurOwn® technology aimed at treating neurodegenerative diseases. These patents, effective across major markets including the U.S., E.U., Canada, Israel, and Hong Kong, strengthen Brainstorm's intellectual property portfolio. CEO Chaim Lebovits emphasized the significant potential of NurOwn in addressing unmet medical needs, particularly for diseases like ALS and MS. The company's innovative MSC-NTF cell therapy has received Orphan Drug designation from the FDA and EMA.
On May 25, 2021, BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented new findings regarding its MSC-NTF (NurOwn®) technology at ISCT 2021. The study demonstrated that NurOwn exosomes significantly improve lung parameters in a mouse model of ARDS, a severe complication of COVID-19. Key improvements included a reduction in pro-inflammatory cytokines and lung damage markers. The enhanced protein cargo in MSC-NTF exosomes was noted as a potential factor for their efficacy. CEO Chaim Lebovits highlighted the strategic focus on ARDS as an unmet medical need while progressing with their ALS and MS therapeutic pipeline.
BrainStorm Cell Therapeutics (BCLI) announced Q1 2021 financial results and significant progress in its clinical trials. The Phase 2 trial of NurOwn® for progressive multiple sclerosis achieved primary safety endpoints, showing clinically meaningful improvements compared to matched cohorts. Cash reserves stood at approximately $40 million. R&D expenses decreased to $4.3 million from $5.9 million YoY, while the net loss shrank to $6.6 million, or $0.19 per share, down from $8.1 million, or $0.32 per share, in Q1 2020. A corporate update highlights ongoing efforts in ALS treatment development and regulatory strategy.
BrainStorm Cell Therapeutics Inc. (BCLI) will hold a conference call on April 26, 2021, at 8:00 a.m. ET to disclose financial results for Q1 2021, which ended on March 31, 2021. CEO Chaim Lebovits will provide updates, followed by a Q&A session. The company focuses on cellular therapies for neurodegenerative diseases, particularly its NurOwn® technology platform, which has received FDA and EMA Orphan Drug designations for treating ALS. The Phase 3 trial for ALS has been completed, with a Phase 2 trial for MS also underway.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced positive topline data from its Phase 2 trial of NurOwn® for progressive multiple sclerosis (MS). The trial met its primary endpoint for safety and demonstrated improvements in secondary outcomes, including neurologic function and cognition. Of the 20 enrolled patients, 16 completed the study, with significant enhancements in measures like the timed 25-foot walk test and cognitive processing tests. The results suggest NurOwn® has potential as a therapeutic option for progressive MS, urging further evaluations and data presentation at scientific meetings.
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