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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.
On May 25, 2021, BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented new findings regarding its MSC-NTF (NurOwn®) technology at ISCT 2021. The study demonstrated that NurOwn exosomes significantly improve lung parameters in a mouse model of ARDS, a severe complication of COVID-19. Key improvements included a reduction in pro-inflammatory cytokines and lung damage markers. The enhanced protein cargo in MSC-NTF exosomes was noted as a potential factor for their efficacy. CEO Chaim Lebovits highlighted the strategic focus on ARDS as an unmet medical need while progressing with their ALS and MS therapeutic pipeline.
BrainStorm Cell Therapeutics (BCLI) announced Q1 2021 financial results and significant progress in its clinical trials. The Phase 2 trial of NurOwn® for progressive multiple sclerosis achieved primary safety endpoints, showing clinically meaningful improvements compared to matched cohorts. Cash reserves stood at approximately $40 million. R&D expenses decreased to $4.3 million from $5.9 million YoY, while the net loss shrank to $6.6 million, or $0.19 per share, down from $8.1 million, or $0.32 per share, in Q1 2020. A corporate update highlights ongoing efforts in ALS treatment development and regulatory strategy.
BrainStorm Cell Therapeutics Inc. (BCLI) will hold a conference call on April 26, 2021, at 8:00 a.m. ET to disclose financial results for Q1 2021, which ended on March 31, 2021. CEO Chaim Lebovits will provide updates, followed by a Q&A session. The company focuses on cellular therapies for neurodegenerative diseases, particularly its NurOwn® technology platform, which has received FDA and EMA Orphan Drug designations for treating ALS. The Phase 3 trial for ALS has been completed, with a Phase 2 trial for MS also underway.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced positive topline data from its Phase 2 trial of NurOwn® for progressive multiple sclerosis (MS). The trial met its primary endpoint for safety and demonstrated improvements in secondary outcomes, including neurologic function and cognition. Of the 20 enrolled patients, 16 completed the study, with significant enhancements in measures like the timed 25-foot walk test and cognitive processing tests. The results suggest NurOwn® has potential as a therapeutic option for progressive MS, urging further evaluations and data presentation at scientific meetings.
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced participation in the 10th Annual SVB Leerink Global Healthcare Conference on February 26, 2021. Dr. Stacy Lindborg, EVP and head of Global Clinical Research, will present a corporate update at 8:40 AM Eastern Time. A live webcast of the presentation can be accessed via the provided link. The company focuses on developing adult stem cell therapies for neurodegenerative diseases. Caution is advised regarding forward-looking statements about clinical trials and financial requirements.
BrainStorm Cell Therapeutics (BCLI) announced that it received initial feedback from the FDA regarding the clinical data from its NurOwn ALS Phase 3 trial. The FDA indicated that the current data does not meet the criteria needed for a Biologics License Application (BLA). However, the FDA's stance allows BrainStorm to still pursue a BLA submission. The company, well-funded with over $40M in cash, plans to consult with ALS experts and stakeholders before making a decision on the BLA submission. They aim to analyze data further and communicate findings in a peer-reviewed publication.
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.
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