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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 (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.
Catalent and BrainStorm Cell Therapeutics have announced a collaboration to manufacture NurOwn®, BrainStorm's cellular therapy for amyotrophic lateral sclerosis (ALS). This partnership will facilitate the transfer of the manufacturing process to Catalent's new facility in Houston, Texas, which spans 32,000 square feet. NurOwn has received Fast Track status from the U.S. FDA and Orphan Drug Status for ALS. Currently, BrainStorm is finalizing a Phase 3 clinical trial with 200 patients. The companies plan to expand their collaboration for commercial supply post-trial success.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced the presentation of a scientific poster on NurOwn® exosomes for treating ARDS at the NYSCF Conference on October 20, 2020. The study demonstrated significant improvements in lung function and reduced inflammation in a mouse model of ARDS, suggesting NurOwn exosomes may be a viable therapy for COVID-19 related lung complications. CEO Chaim Lebovits reaffirmed the company's commitment to advancing their therapeutic pipeline while preparing for the pivotal Phase 3 ALS clinical trial data release.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its third quarter financial results for 2020, highlighting a net loss of $4.49 million, improved from $5.63 million in Q3 2019. The company has approximately $36 million in funding, with significant upcoming events including the NurOwn® Phase 3 trial data readout for ALS expected in November. Additionally, management updates include new appointments to enhance regulatory and commercial strategy, and plans for further clinical trials in progressive multiple sclerosis and Alzheimer's disease.
BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Stacy Lindborg, Ph.D., will present at the 2020 Cell & Gene Meeting on the Mesa, held virtually from October 12-16, 2020. The presentation is available on-demand for registered participants. The conference will showcase over 80 presentations by various companies highlighting advancements in cell therapy and gene therapy. BrainStorm’s NurOwn technology is focused on treating neurodegenerative diseases, including a Phase 3 trial for ALS and a Phase 2 trial for progressive MS, supported by FDA approvals.
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