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. (NASDAQ: BCLI) delivers innovative autologous stem cell therapies targeting neurodegenerative diseases through its NurOwn® platform. This dedicated news hub provides investors and healthcare stakeholders with timely updates on clinical developments, regulatory progress, and strategic initiatives.
Access authoritative reporting on key milestones including clinical trial results, FDA communications, manufacturing partnerships, and scientific presentations. Our curated news collection enables efficient tracking of BCLI's progress in advancing treatments for ALS, multiple sclerosis, and Parkinson's disease.
Key content categories include:
- Clinical trial phase updates
- Regulatory submissions and designations
- Research collaborations
- Peer-reviewed publication highlights
- Financial reporting
Bookmark this page for consolidated access to verified BCLI developments. Check regularly for updates on novel cellular therapies addressing critical unmet medical needs in neurology.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced a successful Type C meeting with the FDA regarding manufacturing modifications for NurOwn®. The meeting provided actionable guidance on transitioning to a semi-automated manufacturing process, aimed at increasing capacity and reducing manufacturing risks. The company plans to finalize a comparability plan and conformance batches for NurOwn® while leveraging FDA feedback. This development marks a positive step in BrainStorm's efforts to advance the regulatory submission for NurOwn®, which seeks to treat neurodegenerative diseases like ALS.
BrainStorm Cell Therapeutics (BCLI) announced significant financial results for 2020, marked by the completion of its pivotal Phase 3 ALS trial for NurOwn®. While the trial did not achieve statistical significance in its primary endpoint, analyses indicate a clinically meaningful effect. Financially, cash and liquidity stood at approximately $45 million at the start of 2021, a substantial increase from $0.6 million in 2019. The net loss for 2020 rose to $31.8 million from $23.3 million in 2019. The company aims to advance its clinical programs in multiple sclerosis and Alzheimer's disease in 2021.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) will hold a conference call on February 4, 2020, at 8:00 a.m. ET to discuss its financial results for Q4 and the fiscal year ended December 31, 2020. The call will include an update from CEO Chaim Lebovits, followed by a Q&A session. Key developments include the completion of a Phase 3 trial for ALS and an ongoing Phase 2 trial for progressive MS, with topline results expected in Q1 2021. The company is also in discussions with the FDA regarding regulatory pathways for NurOwn® approval.
BrainStorm Cell Therapeutics (BCLI) announced the publication of a preclinical study on NurOwn® exosomes in the journal Stem Cell and Research Therapy. The study demonstrated that the intratracheal administration of NurOwn® exosomes led to significant reductions in lung disease severity in a mouse model of ARDS, a condition often associated with COVID-19. Results showed superior improvements over naïve MSC-derived exosomes in various ARDS markers. BrainStorm aims to explore the therapeutic potential of this approach while advancing NurOwn® towards regulatory approval for ALS.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported significant advancements in 2020, highlighted by the completion of the Phase 3 ALS clinical trial for NurOwn®. Although the primary efficacy endpoint did not achieve statistical significance, pre-specified subgroup analyses demonstrated a clinically meaningful treatment effect. The company is engaging with the FDA on regulatory pathways for NurOwn's approval. Additionally, a new Expanded Access Program has been initiated for ALS patients. With over $40 million in cash and ongoing manufacturing capabilities expansion, BrainStorm aims to address the unmet needs in neurodegenerative diseases.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced the completion of all dosing in its Phase 2 clinical trial for NurOwn®, a treatment for progressive multiple sclerosis (MS). Conducted at five sites in the U.S., this trial represents a significant milestone for the company. CEO Chaim Lebovits expressed gratitude to the trial participants and investigators, emphasizing the potential of NurOwn to provide therapeutic options for MS patients. Top-line results are expected by the end of Q1 2021, which may influence further development and market acceptance of NurOwn.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) has initiated an Expanded Access Program (EAP) for its autologous MSC-NTF cells, branded as NurOwn®, for ALS patients who participated in a recent Phase 3 clinical trial. Developed in collaboration with the FDA, the EAP allows select trial participants to access the investigational treatment. The initial focus will be on ALS patients less severely affected, based on the Revised ALS Functional Rating Scale. The EAP highlights the urgency recognized by BrainStorm and the ALS community for immediate treatment options.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that results from the Phase 3 trial of NurOwn® treatment for ALS will be presented at the 31st International Symposium on ALS/MND on December 9-11, 2020. The trial involved 189 patients and assessed the safety and efficacy of NurOwn®. The company aims to increase awareness and discuss regulatory pathways for the treatment. Key presenters include Ralph Kern and Merit Cudkowicz, highlighting the importance of the trial's biomarker outcomes for ALS treatment response. The company is also exploring further clinical opportunities.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced results from its Phase 3 trial of NurOwn® for ALS. The therapy was generally well tolerated, showing a numerical improvement over placebo in key efficacy endpoints, although not statistically significant. In a subgroup of patients with early disease, NurOwn demonstrated a meaningful treatment response. Biomarker analysis indicated positive neurotrophic factor effects correlated with treatment. The company is in discussions with the FDA regarding potential approval pathways.
BrainStorm Cell Therapeutics (BCLI) has partnered with Rapid Reshore & Development (RR&D) to establish a new manufacturing facility for its cell therapy NurOwn in the U.S. This facility aims to support the production of treatments for neurodegenerative diseases like ALS and MS. The site selection and design process will begin immediately, with a facility size of approximately 50,000 square feet, expandable to 100,000 square feet. This expansion is crucial for preparing for potential regulatory approvals and enhancing production capabilities.
