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 (OTCQB: BCLI) reported Q3 2025 results and a corporate update on Nov 14, 2025. The FDA cleared the planned Phase 3b ENDURANCE study of NurOwn for ALS, which is expected to enroll ~200 participants and includes a 24-week randomized double-blind period plus a 24-week open-label extension. Part A's primary endpoint is change on the ALSFRS-R at Week 24, with data intended to support a BLA submission. The company noted a Citizen Petition filed by ALS community representatives and said it did not participate in that filing. Financials: cash and equivalents were approximately $0.23M at Sept 30, 2025; Q3 net loss was $2.1M and net loss per share was $0.19.
BrainStorm Cell Therapeutics (OTCQB: BCLI), a developer of adult stem cell therapeutics, reported Q2 2025 financial results and significant developments for its NurOwn® therapy. The company received FDA clearance for a Phase 3b trial (ENDURANCE) designed to support a potential BLA submission, planning to enroll approximately 200 participants.
Key highlights include promising survival data from the NurOwn Expanded Access Program, showing 100% of participants surviving beyond 5 years from ALS symptom onset, with a median survival of 6.8 years. The company signed an LOI with Minaris Advanced Therapies for manufacturing support and presented breakthrough pharmacogenomic data at ISCT 2025.
Financial results show cash position of $1.03 million, with a quarterly net loss of $2.9 million ($0.34 per share), compared to $2.54 million ($0.60 per share) in Q2 2024.
BrainStorm Cell Therapeutics (OTCQB: BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, will host its Q2 2025 financial results conference call on August 14, 2025, at 8:30 AM ET.
The call will feature presentations from key executives including CEO Chaim Lebovits, COO Hartoun Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis, followed by a Q&A session. Investors can submit questions in advance to q@brainstorm-cell.com by August 12, 2025, at 10:00 AM ET.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its delisting from the Nasdaq Capital Market effective July 18, 2025, due to non-compliance with minimum shareholder equity requirements. The company's shares will transition to the OTCQB Venture Market under the same symbol BCLI.
CEO Chaim Lebovits emphasized that despite this setback, the company remains committed to advancing NurOwn for ALS patients, including preparations for a pivotal Phase 3b trial under an FDA Special Protocol Assessment agreement. The delisting will not affect BrainStorm's business operations, R&D efforts, or SEC compliance obligations.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that the FDA will review a Citizen Petition requesting a new evaluation of data supporting NurOwn®, their ALS treatment therapy. The company, while not involved in the petition's submission, welcomes this development as an opportunity to reaffirm NurOwn's potential effectiveness.
Key clinical findings include: statistically significant functional improvement in patients with baseline ALSFRS-R scores ≥35, preservation of two more ALSFRS-R points compared to placebo, and remarkable survival data showing median survival of 6.8 years in Expanded Access Program participants.
BrainStorm will proceed with its planned Phase 3b ENDURANCE trial under FDA Special Protocol Assessment while exploring potential regulatory pathways for NurOwn access.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has signed a Letter of Intent with Minaris Advanced Therapies for manufacturing NurOwn®, its adult stem cell therapy for ALS treatment. The partnership will facilitate technology transfer and clinical trial manufacturing at Minaris' Allendale, New Jersey facility in preparation for BrainStorm's planned Phase 3b clinical trial.
This U.S.-based manufacturing collaboration complements BrainStorm's recent partnership with Pluri Inc. (Nasdaq: PLUR) in Israel, establishing a robust manufacturing network for NurOwn®. The strategic relationship aims to advance the clinical development of this therapy for ALS patients through a multicenter Phase 3b trial.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received FDA clearance to begin a Phase 3b clinical trial of NurOwn® for treating ALS. The trial design was approved under a Special Protocol Assessment (SPA), confirming its suitability for a future Biologics License Application. The study will involve approximately 200 participants at leading academic medical centers, featuring a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants will receive NurOwn®. The primary endpoint will measure changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) from baseline to week 24.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has rescheduled its Q1 2025 financial results release to post-market close on May 15, 2025, with an investor conference call now set for Monday, May 19, 2025, at 8:30 a.m. ET. The call will feature CEO Chaim Lebovits presenting a corporate update, joined by COO Haro Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis.
BrainStorm is developing adult stem cell therapies for neurodegenerative diseases, with its flagship NurOwn® platform using autologous mesenchymal stem cells to produce neurotrophic factor-secreting cells. The company has completed a Phase 3 trial for ALS and is preparing to launch a confirmatory Phase 3b trial under an FDA Special Protocol Assessment agreement. Additionally, BrainStorm has completed a Phase 2 trial for progressive MS and is advancing an allogeneic exosome-based platform.
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