Retail Bulls Cheer FDA Clearance For BrainStorm’s ALS Therapy, But Shares Dip After Hours

BrainStorm Cell Therapeutics saw rising retail chatter Monday when it obtained FDA clearance for Phase 3b clinical trials of NurOwn, its amyotrophic lateral sclerosis (ALS) stem cell therapy candidate.

Through a Special Protocol Assessment (SPA), the FDA confirmed that the study design and statistical methodology meet regulatory standards required for future BLAs.

The company’s shares closed up 3.03% at $1.36 on Monday but slipped 12.54% to $1.19 in after-hours trading.

BrainStorm CEO Chaim Lebovits said the FDA approval allows the company to commence operations at clinical sites while it pursues funding through multiple sources, such as non-dilutive grants.

The clinical Phase 3b trial aims to enroll around 200 ALS patients from leading academic institutions. 

A 24-week double-blind placebo-controlled trial will initiate the study before moving into a 24-week open-label extension, during which all patients receive NurOwn. 

Researchers will assess the primary outcome by measuring the change in ALSFRS-R scores from baseline to week 24.

Completing Phase 3 research allows NurOwn to hold Orphan Drug status concurrently in the United States and the European Union. 

Meanwhile, the U.S. Patent Office approved BrainStorm's intellectual property rights to develop an allogeneic exosome-based platform.

On Stocktwits, retail sentiment was ‘extremely bullish’ amid a 31,000% surge in 24-hour message volume.

Some traders pointed to the company’s pursuit of private grants or potential partnerships, with names like Johns Hopkins University and Pfizer mentioned as speculative collaborators, as key bullish drivers.

Others noted the heavy intraday volume, which reached 58 million shares, expressing frustration over the lack of price movement during regular hours. 

Still, optimism remained for a possible after-hours push or improved action in the following session, with hopes for reduced resistance ahead.

The stock has declined 36.5% so far in 2025.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

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