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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.
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.
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.
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