Welcome to our dedicated page for Brainstorm Cell Therapeutics I news (Ticker: BCLI), a resource for investors and traders seeking the latest updates and insights on Brainstorm Cell Therapeutics I stock.
BrainStorm Cell Therapeutics Inc. (BCLI) generates a steady flow of news centered on its NurOwn® autologous stem cell platform for neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS). Company press releases highlight clinical milestones, regulatory interactions, financing developments, and scientific presentations that shape the outlook for its lead investigational therapy.
News coverage frequently focuses on clinical trial progress for NurOwn, including the completed Phase 3 ALS study and preparations for the Phase 3b ENDURANCE trial under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration. Updates describe FDA clearance to initiate the Phase 3b trial, submission of an IND amendment, listing of the study on ClinicalTrials.gov, and operational steps such as site activation and manufacturing readiness.
Investors and observers will also find data-driven announcements, such as survival results from BrainStorm’s Expanded Access Program in ALS and pharmacogenomic and biomarker analyses presented at scientific meetings. These releases detail how NurOwn-treated cohorts performed relative to published ALS survival estimates and discuss factors like the UNC13A genotype and cerebrospinal fluid biomarker pathways.
Additional news items cover regulatory and community developments, including the FDA’s consideration of a Citizen Petition requesting renewed review of NurOwn data, as well as BrainStorm’s engagement with the ALS community. Financial results and capital-raising activities are reported through quarterly earnings releases and 8-K filings, alongside information about promissory and convertible promissory notes.
Stock Titan’s BCLI news page aggregates these company-issued updates and related coverage, allowing readers to follow clinical, regulatory, scientific, and financing events that may influence BrainStorm’s development trajectory. For those tracking BCLI, this page offers a single location to review the latest disclosed information on NurOwn, ALS and MS programs, manufacturing partnerships, and listing status changes.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will present its research on MSC-NTF (NurOwn®) exosomes for treating acute lung injury on October 19, 2021, at the NYSCF 2021 Virtual Meeting. The study compares the effectiveness of exosomes from naïve MSCs and those enhanced to secrete regenerative factors. Findings indicate that MSC-NTF exosomes significantly improve oxygen saturation and reduce lung inflammation and fibrosis compared to naïve MSC exosomes. This suggests potential clinical applications for MSC-NTF in lung-related disorders.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced findings from a Phase 2 clinical trial of NurOwn® for progressive multiple sclerosis, presented at the 37th ECTRIMS Congress. The trial achieved its primary endpoint, demonstrating safety and tolerability. Key outcomes included reduced neuroinflammatory biomarkers and improved MS functional measures such as walking and cognitive functions. Notably, 38% of treated patients showed significant walking improvement. BrainStorm seeks FDA guidance for future development steps, indicating potential market impact.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific abstract regarding its NurOwn Phase 3 clinical trial at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium conference. The study investigates biomarkers that predict clinical outcomes in ALS patients. Key speakers include Dr. James Berry and executives emphasizing NurOwn's significance in ALS treatment. The company aims to clarify the therapy's mechanisms, supported by positive results across biomarker domains such as neurodegeneration. Detailed findings will be available on BrainStorm's website following the conference.
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.