24/7 Market News Snapshot 10 April, 2025 – Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI)

April 10, 2025

DENVER, Colo., 10 April, 2025 (www.247marketnews.com) – (NASDAQ:BCLI) are discussed in this article.
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) is experiencing significant momentum in the pre-market trading session, with its share price appreciating approximately 13.77% to reach $1.268, compared to the previous closing price of $1.115. This robust performance is accompanied by heightened investor activity, with trading volumes soaring to 995.02K shares, signaling strong market interest in the company’s promising developments.

A key driver of this bullish trend is the recent submission of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) for NurOwn®, a novel autologous mesenchymal stem cell therapy aimed at tackling amyotrophic lateral sclerosis (ALS). This pivotal step marks the company’s preparation for a Phase 3b clinical trial, which has been designed in close consultation with the FDA under a Special Protocol Assessment (SPA). The SPA validates that the trial’s design and statistical analysis plan align with regulatory standards, which is essential for a future Biologics License Application (BLA).

BrainStorm’s CEO, Chaim Lebovits, expressed optimism regarding the recent IND amendment submission, underscoring its importance in bringing NurOwn to ALS patients. He emphasized the company’s commitment to facilitating a swift review process to commence the clinical trial.

The Phase 3b trial is set to involve around 200 ALS participants, structured in a two-part format. The initial phase will see subjects receiving either NurOwn or a placebo during a double-blind period of 24 weeks, followed by an open-label extension for those initially in the placebo group, allowing them to receive the treatment.

As BrainStorm advances its clinical ambitions, the company remains steadfast in its collaboration with regulatory authorities and stakeholders, dedicated to addressing the significant unmet needs in the ALS therapeutic arena. Further updates will be provided as the FDA’s review progresses.

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