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) completed participant dosing in its Phase 3 trial of NurOwn® for amyotrophic lateral sclerosis (ALS). Approximately 200 participants received either MSC-NTF cells or a placebo over four months. The company anticipates top-line data by Q4 2020, aligning with their enrollment timeline. CEO Chaim Lebovits emphasized this milestone's importance for a potential Biologics License Application. The trial is being conducted at six renowned medical centers, and the company has a recent FDA clearance for a Phase 2 trial in progressive multiple sclerosis.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will host a KOL webinar on its Alzheimer's disease clinical program on July 8, 2020, at 8:15 AM ET. The webinar will feature presentations from Dr. Philip Scheltens and Dr. Bruno Dubois, lead investigators of a Phase 2 trial assessing NurOwn® in 40 participants with prodromal to mild AD. The trial aims to evaluate the efficacy of autologous MSC-NTF cells, designed to deliver neurotrophic factors targeting neurodegenerative disorders. BrainStorm's expansion into Alzheimer's comes after successful developments in ALS and progressive multiple sclerosis.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced a new clinical program to develop NurOwn for treating Alzheimer's disease. A multi-national Phase 2 clinical trial is planned to evaluate the safety and efficacy of NurOwn in patients with prodromal to mild Alzheimer's. The trial will include 40 participants receiving three doses over 52 weeks. The company aims to build on its existing ALS program and believes NurOwn can potentially address various neurodegenerative disorders.
BrainStorm Cell Therapeutics (BCLI) announced its inclusion in the Russell 2000® and Russell 3000® Indexes effective June 29, 2020. This addition is significant as it reflects BrainStorm’s market capitalization and positions the company for greater visibility and investment opportunities. The Russell Indexes are widely used by investment managers and institutional investors, with approximately $9 trillion in assets benchmarked against these indexes.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its Q1 2020 financial results and provided updates on clinical trials amid the COVID-19 pandemic. The Phase 3 ALS trial is on track for Q4 2020 data readout, with patient treatments ongoing. The company signed an agreement for EMEA regulatory guidance and leased a facility in Tel Aviv to enhance manufacturing capacity. Despite challenges, cash reserves increased to $14.5 million but net losses widened to $8.1 million, compared to $5.03 million in Q1 2019.
BrainStorm Cell Therapeutics announced a lease with Tel Aviv Sourasky Medical Center to produce NurOwn® in new cleanrooms, enhancing manufacturing capacity for ALS treatment in Israel and the EU. This collaboration aims to ensure rapid production post-regulatory approval, supporting ongoing clinical demands. The cleanroom facility complies with cGMP standards, indicating a significant step toward scaling up operations. With full enrollment in a Phase 3 ALS trial and recent FDA clearance for a Phase 2 MS trial, BrainStorm is positioned to advance its therapeutic pipeline significantly.
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