Micro-Cap Biotech Spikes After Revealing Strong ALS Survival Outcomes

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Monday, June 16, 2025

ALS is a rapidly progressing and incurable disease that attacks motor neurons, leading to muscle weakness, paralysis, and ultimately death—often within just 3 to 5 years. With limited treatment options available, there remains an urgent need for medical breakthroughs. This morning, one micro-cap company delivered a compelling update related to ALS that has sent its shares sharply higher.

As mentioned, shares of BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) are on the move higher as the company announced compelling new survival data from its Expanded Access Program (EAP) for NurOwn®, an adult stem cell therapy for amyotrophic lateral sclerosis (ALS). The program included 10 participants who had previously taken part in the company’s Phase 3 clinical trial. Survival was tracked from the initial onset of ALS symptoms through the clinical trial and EAP periods, using both direct data and publicly available records. At the start of the Phase 3 trial, participants were in the early stages of the disease, with a mean ALSFRS-R score of 35.8, which slightly declined to 31.4 by the start of the EAP.

The key finding from this cohort is that 90% (9 out of 10) of participants survived more than five years after symptom onset—an extraordinary result given that only about 10% of ALS patients typically reach that milestone. The lone death in the group occurred due to elective euthanasia, not disease progression. The median survival for the cohort was 6.8 years, significantly exceeding expected outcomes. The company emphasized that the likelihood of such extended survival occurring by chance is extremely low, suggesting a potential survival benefit from NurOwn treatment.

Bob Dagher, MD, Chief Medical Officer of BrainStorm Cell Therapeutics, stated: "The fact that 9 out of 10 EAP participants surpassed five years of survival from first symptom - in contrast with the very modest expected survival pattern typically seen in ALS - represents a clinically meaningful observation. Furthermore, 6 out of 10 patients are still alive, even post seven years from symptom onset. These data further strengthen the scientific rationale to pursue our pivotal Phase 3b trial of NurOwn in ALS, under full alignment with the FDA guidance."

Investors rallied behind the announcement, sending shares of BCLI up 13.64% at $1.25 in early-afternoon trading.

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