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) highlights key achievements in 2024, including securing a Special Protocol Assessment (SPA) with the FDA for NurOwn's Phase 3b clinical trial and aligning on Chemistry, Manufacturing, and Controls (CMC) plans. The company entered an MOU with Pluri Inc. for clinical manufacturing and strengthened its leadership team with new appointments.
Biomarker studies showed NurOwn's potential to reduce neurofilament light levels in ALS patients. The company raised approximately $8 million since the previous ADCOM results and is pursuing additional funding. Looking ahead to 2025, BrainStorm plans to execute the Phase 3b trial focusing on early-stage ALS patients and advance its exosome platform development.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced two significant upcoming events. The company will host a corporate update conference call on December 30, 2024, at 8:30 AM ET, featuring presentations from key executives including CEO Chaim Lebovits, COO Hartoun Hartounian, and CDO Bob Dagher. Investors can participate through dial-in numbers or webcast, with a Q&A session following the presentations.
Additionally, the company will host a Key Opinion Leader Webinar focused on ALS treatment developments on December 11, 2024, at 10:00 AM ET, featuring Dr. Terry Heiman Patterson from Temple University. Questions for the corporate update call can be submitted in advance to q@brainstorm-cell.com by December 22, 2024.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received a Notice of Allowance from the USPTO for patent application 16/981,757, covering its proprietary exosome technology. The patent protects the composition and method of unique exosomes isolated from MSC-NTF cells, containing specific neurotrophic factors (LIF, VEGFA, GDF-15) and potentially additional proteins or microRNA molecules. The patent is expected to provide protection until April 10, 2039. The company aims to strengthen its position in cellular and exosome-based therapies while focusing on NurOwn development for ALS through an upcoming Phase 3b registrational trial.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announces a KOL webinar scheduled for December 11, 2024, at 10:00 AM ET, focusing on Amyotrophic Lateral Sclerosis (ALS) treatment developments. The event will feature Dr. Terry Heiman-Patterson from Temple University's Lewis Katz School of Medicine, who will discuss the current ALS treatment landscape. BrainStorm's management will provide updates on their planned Phase 3b registrational clinical trial for NurOwn® (autologous MSC-NTF cells) and future development plans. The successful completion of Part A of the Phase 3b trial is expected to support a Biologic License Application (BLA) for NurOwn. The webinar will conclude with a live Q&A session.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced Q3 2024 financial results and updates on its NurOwn® program. The company is preparing for a Phase 3b registration trial of NurOwn in ALS, partnering with Pluri Inc. for manufacturing. The trial will enroll approximately 200 ALS patients in a two-part study. Financial highlights show cash and equivalents of $0.35 million, R&D expenses of $1 million (down from $3.3 million in Q3 2023), and a net loss of $2.7 million ($0.51 per share) compared to $1.2 million ($0.45 per share) in Q3 2023.
BrainStorm Cell Therapeutics has signed a Memorandum of Understanding (MOU) with Pluri to manufacture NurOwn® for the planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This agreement will enable BrainStorm to transfer its manufacturing technology and start production at Pluri's GMP-compliant facility in Israel upon finalizing a definitive agreement. The collaboration aims to meet the supply requirements for the Phase 3b trial and explore future commercial distribution options, pending NurOwn's approval. The trial will enroll up to 200 participants and is designed in two parts: a 24-week double-blind period followed by a 24-week open-label period. The primary endpoint is the change in ALSFRS-R score from baseline to week 24. BrainStorm will provide further updates in Q4 2024.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received written notice from Nasdaq confirming its regained compliance with the minimum closing bid price requirement under Listing Rule 5550(a)(2). The notice, received on October 29, 2024, ensures the company's continued listing on The Nasdaq Capital Market, subject to maintaining compliance with Nasdaq's listing requirements.
BrainStorm Cell Therapeutics presented positive survival data from NurOwn's Expanded Access Program (EAP) at the 2024 NEALS Meeting. The study included 10 ALS patients, showing significant survival benefits with a median survival time of 46.6 months for the debamestrocel group versus 41.1 months for matched controls. Neurofilament light (NfL) biomarker data indicated reduced neurodegeneration in treated patients. The company also presented details of an upcoming Phase 3b trial that will enroll approximately 200 participants to receive either debamestrocel or placebo, followed by an open-label period.
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Chaim Lebovits will join a Fireside Chat on October 15 at 9:30 a.m. ET to provide an update on the planned Phase 3b clinical trial for NurOwn®, the company's investigational cell therapy for ALS.
The summit, taking place from October 15 to 17, will feature presentations and discussions led by senior analysts, focusing on critical healthcare trends. The event offers an opportunity for BrainStorm to engage with the investment community and share insights into their upcoming trial. Interested parties can access the conference live on M-Vest by signing up as members.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the acceptance of two abstracts featuring NurOwn® (MSC-NTF or Debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting. The company's priority is initiating a Phase 3b clinical trial to confirm NurOwn's efficacy in early-stage ALS patients. Two presentations are scheduled:
1. "Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program" by Bob Dagher, MD.
2. "An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS" by Bob Dagher, MD.
NurOwn® is an autologous MSC-NTF cell therapy targeting neurodegenerative disorders, with ALS as the lead program. The clinical program has provided insights into ALS pathology, disease progression, and treatment.