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Brainstorm Cell Therapeutics Inc. - BCLI STOCK NEWS

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.

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BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that Dr. Ralph Kern will present a corporate overview at the 12th Annual California ALS Research Summit on January 27, 2022, at 4:45 p.m. ET. The summit, held virtually on January 27-28, focuses on advancing research in neurodegenerative diseases. BrainStorm's NurOwn® technology, which utilizes autologous MSC-NTF cells, aims to treat conditions like ALS and has received Orphan Drug designation from the FDA and EMA. For more details and registration, visit the official summit page.

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BrainStorm Cell Therapeutics (NASDAQ: BCLI) will present a corporate and clinical overview at Biotech Showcase™ 2022, scheduled virtually on January 10-12 and 17-18. Ralph Kern, M.D., President and CMO, will lead the presentation, which will be pre-recorded for registered attendees. The company is notable for its NurOwn® technology, targeting neurodegenerative diseases. NurOwn® cells, derived from autologous stem cells, aim to deliver neurotrophic factors to affected areas to combat conditions like ALS. BrainStorm has completed significant trials, including a Phase 3 study in ALS and a Phase 2 trial in progressive MS.

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BrainStorm Cell Therapeutics (NASDAQ: BCLI) has announced an extension of the NurOwn® Expanded Access Protocol (EAP) for patients with neurodegenerative diseases, following FDA recommendations. Eligible participants who completed the Phase 3 NurOwn trial can now receive up to 3 additional doses, increasing the total to 9 doses. The decision was informed by new analysis and biomarkers from the Phase 3 study. This initiative aims to provide more treatment options and gather further data on long-term effects.

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BrainStorm Cell Therapeutics (BCLI) announced the peer-reviewed publication of Phase 3 clinical data in Muscle and Nerve for its NurOwn® therapy aimed at ALS treatment. While the trial did not achieve statistical significance in its primary and secondary endpoints, analyses indicate a treatment effect in patients with less advanced disease. Key findings revealed larger treatment effects in these subgroups and significant biomarker improvements in neuroinflammation and neurodegeneration. The study reinforces the potential of NurOwn to provide clinical benefits for ALS patients and emphasizes the need for further evaluation.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of Brainstorm Cell Therapeutics (BCLI)?

The current stock price of Brainstorm Cell Therapeutics (BCLI) is $2.16 as of January 23, 2025.

What is the market cap of Brainstorm Cell Therapeutics (BCLI)?

The market cap of Brainstorm Cell Therapeutics (BCLI) is approximately 11.9M.

What is Brainstorm Cell Therapeutics Inc.?

Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a biotechnology company focused on developing innovative autologous stem cell therapies for neurodegenerative disorders such as ALS, MS, and Parkinson's disease.

What is NurOwn® technology?

NurOwn® is Brainstorm's proprietary technology platform that involves the differentiation of autologous Mesenchymal Stem Cells into neurotrophic factor-secreting cells, which are then transplanted near damaged tissue sites to treat neurodegenerative diseases.

What are the recent achievements of Brainstorm Cell Therapeutics?

Recent achievements include securing a Special Protocol Assessment (SPA) from the FDA for a Phase 3b trial of NurOwn in ALS, as well as obtaining new patents in Europe, Australia, and Israel.

What is the Special Protocol Assessment (SPA) from the FDA?

The SPA is an agreement with the FDA that validates the clinical trial protocol and statistical analysis plan, supporting a future Biologics License Application for ALS treatment with NurOwn.

Which diseases are targeted by Brainstorm's therapies?

Brainstorm's therapies target neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD).

What phase are Brainstorm's clinical trials in?

Brainstorm has completed a Phase 3 trial for ALS and is planning a Phase 3b trial. They have also conducted a Phase 2 trial for Progressive MS.

How is Brainstorm Cell Therapeutics funded?

Brainstorm is funded through a combination of grants from organizations such as CIRM and the ALS Association, as well as investor capital.

What is the significance of the new patents obtained by Brainstorm?

The new patents enhance Brainstorm's intellectual property portfolio, allowing for expanded global commercial partnerships and safeguarding the proprietary NurOwn technology.

How does NurOwn® work?

NurOwn® works by converting autologous Mesenchymal Stem Cells into neurotrophic factor-secreting cells that are transplanted near damaged tissues to deliver targeted treatments for neurodegenerative diseases.

Where can I find the latest news on Brainstorm Cell Therapeutics?

You can find the latest news on Brainstorm Cell Therapeutics by visiting their official website or following their news releases.
Brainstorm Cell Therapeutics Inc.

Nasdaq:BCLI

BCLI Rankings

BCLI Stock Data

11.86M
4.45M
9.04%
13.9%
2.07%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
NEW YORK