Welcome to our dedicated page for Brainstorm Cell Therapeutics news (Ticker: BCLI), a resource for investors and traders seeking the latest updates and insights on Brainstorm Cell Therapeutics stock.
Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a pioneering biotechnology company focused on developing advanced autologous stem cell therapies aimed at treating severe neurodegenerative disorders. These include highly debilitating diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS), and Parkinson’s Disease (PD), which currently have limited treatment options.
The cornerstone of Brainstorm's innovative approach is its NurOwn® technology platform. This proprietary technology involves the propagation and differentiation of autologous Mesenchymal Stem Cells (MSCs) into neurotrophic factor (NTF) secreting cells. These MSC-NTF cells are then transplanted at or near the damaged tissue sites, essentially converting MSCs into a living drug delivery system for NTFs that can target specific neurodegenerative diseases.
Brainstorm has demonstrated proof-of-concept in various animal models for diseases including ALS, MS, Parkinson's, Huntington's, and peripheral nerve injuries. The company's commitment to ALS treatment is underscored by the completion of multiple clinical trials, including a Phase 3 trial, which investigated the safety and efficacy of repeat administration of MSC-NTF cells, supported by grants from the California Institute for Regenerative Medicine (CIRM) and the ALS Association.
Most recently, Brainstorm achieved a significant milestone by securing a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for the design of a Phase 3b trial of NurOwn in ALS patients. This agreement with the FDA validates the clinical trial protocol and statistical analysis, supporting a future Biologics License Application (BLA) for ALS. The Phase 3b trial aims to enroll up to 200 participants and will involve a double-blind, placebo-controlled period followed by an open-label extension period, focusing on patients earlier in the course of ALS.
Additionally, Brainstorm has fortified its intellectual property portfolio with new patents granted in Europe, Australia, and Israel, enhancing its capability to forge global commercial partnerships for NurOwn. The company's efforts in preclinical research, rigorous clinical trials, and strong collaboration with regulatory agencies and the ALS community underscore its dedication to bringing novel treatment options to patients in need.
Brainstorm's financial condition remains robust, supported by diverse grants and collaborative efforts with advocacy groups. The company continues to advance its pipeline with ongoing clinical trials for progressive MS and plans to expand its research into other neurodegenerative conditions.
For the latest updates on Brainstorm Cell Therapeutics Inc. and its groundbreaking developments, visit their official website or follow their news releases.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) and Catalent (NYSE: CTLT) have finalized the technology transfer for manufacturing the autologous cellular therapy NurOwn® at Catalent's Houston facility. This collaboration began in 2020, aiming to ensure CGMP clinical supply in anticipation of regulatory approval for NurOwn, which targets ALS and other neurodegenerative diseases. Both companies express optimism about the manufacturing process, emphasizing the complexity of cellular therapies and their commitment to advancing the therapy toward commercialization.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of biomarker data on its therapy NurOwn® at the 32nd International Symposium on ALS/MND from December 7-10, 2021. Dr. Robert Brown will deliver the presentation, focusing on how NurOwn targets multiple disease pathways in ALS. Key findings show significant cerebrospinal fluid (CSF) biomarker changes linked to clinical outcomes. These insights support NurOwn's potential as a novel therapy for ALS, highlighting the importance of targeting various disease pathways to enhance treatment efficacy.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented new analyses from its Phase 3 NurOwn trial targeting ALS at the ALS ONE Research Symposium. Despite the trial not meeting primary and secondary endpoints statistically, analyses suggest potential treatment effects in patients with less severe baseline ALS. Key findings indicated a higher responder rate for NurOwn in participants predicted to have longer survival. The company plans to share further results through peer-reviewed publications and is committed to advancing NurOwn's availability to ALS patients.
BrainStorm Cell Therapeutics (BCLI) announced Q3 2021 financial results, reporting a net loss of $5.3 million compared to $4.5 million a year earlier. Cash reserves decreased to $28 million. Progress was noted in advancing NurOwn for ALS and MS, with promising Phase 3 ALS biomarker data shared at the NEALS conference. Newly appointed executives aim to enhance growth strategies, and GMP approval was secured for expanded manufacturing capacity in Israel. The company remains focused on addressing the urgent needs of ALS patients.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) has appointed Sidney A. Spector, MD, PhD, and Kim Thacker, MD, to key roles in Global Strategy and Medical Affairs, as part of its growth strategy. Additionally, Stacy Lindborg, PhD, becomes Chief Development Officer. These leadership changes aim to enhance the company's clinical development and regulatory affairs, particularly for the NurOwn® platform, which is under consideration for regulatory approval for treating neurodegenerative diseases. The company has completed pivotal Phase 3 trials for ALS and is expanding its portfolio.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) appointed Dr. Menghis Bairu to its Board of Directors effective October 28, 2021. Dr. Bairu, a physician and entrepreneur with extensive experience in biotechnology, expressed enthusiasm for contributing to BrainStorm's mission of developing therapies for neurodegenerative diseases. He is the founder and CEO of Proxenia Venture Partners and has held significant roles in various biotech firms, including leading major transactions worth billions. Meanwhile, Sankesh Abbhi will not stand for re-election at the upcoming annual shareholder meeting.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced a conference call scheduled for November 15, 2021, at 8:00 a.m. ET to discuss third-quarter financial results and corporate updates. CEO Chaim Lebovits will lead the call, addressing shareholder inquiries following a financial performance overview. Participants can submit questions until November 14, 2021. The company continues to develop its NurOwn® MSC-NTF cellular therapy platform for neurodegenerative diseases, notably receiving Orphan Drug designation for treating ALS.
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.
FAQ
What is the current stock price of Brainstorm Cell Therapeutics (BCLI)?
What is the market cap of Brainstorm Cell Therapeutics (BCLI)?
What is Brainstorm Cell Therapeutics Inc.?
What is NurOwn® technology?
What are the recent achievements of Brainstorm Cell Therapeutics?
What is the Special Protocol Assessment (SPA) from the FDA?
Which diseases are targeted by Brainstorm's therapies?
What phase are Brainstorm's clinical trials in?
How is Brainstorm Cell Therapeutics funded?
What is the significance of the new patents obtained by Brainstorm?
How does NurOwn® work?
Where can I find the latest news on Brainstorm Cell Therapeutics?
