NurOwn

BrainStorm is a small company based in New York and Israel whose main product is NurOwn. Its shares moved from Nasdaq to the OTCQB market in July 2025, and in 2026 it has raised only small amounts of money (around US$1 million at a time). A former FDA associate commissioner, Peter Pitts, became executive chairman in July 2026.

Doctors collect bone marrow from the person with ALS, and the lab turns its mesenchymal stem cells into cells that release high levels of growth factors that support nerves. These cells are then injected into the spinal fluid by lumbar puncture. The aim is to protect motor neurons and calm inflammation, not to replace lost neurons.

The first Phase 3 trial (189 people) missed its main goal, and in September 2023 FDA advisers voted 17 to 1 that the evidence did not show it works; BrainStorm then withdrew its approval application. The FDA agreed the design of a new Phase 3b trial in April 2024 and cleared it to start in May 2025. In May 2026 BrainStorm said starting depends on securing financing, and it reported only about US$0.2 million in cash at the end of June 2026.

In the Phase 3 trial, 32.6% of people on NurOwn met the "responder" definition versus 27.7% on placebo, which was not a significant difference (p=0.45). In a pre-planned group with less advanced ALS (ALSFRS-R score of 35 or more), the ALSFRS-R score fell about 2 points less with NurOwn, a borderline result (p=0.050) that is not considered proof. The earlier Phase 2 trial (48 people) also found no difference in decline overall. FDA reviewers concluded the data did not show substantial evidence that it works. The new ENDURANCE trial is meant to test the earlier-stage group properly.

This is the most favourable result reported. See all key studies for the full picture.

ENDURANCE plans to enrol about 200 people whose symptoms began within the last 24 months and whose breathing (slow vital capacity) is still at least 65% of normal. Half will get NurOwn and half placebo for 24 weeks, followed by an open-label period where everyone can get it.

BrainStorm says it is completing the operational and regulatory work to open ENDURANCE, and that enrolment depends on securing the necessary financing. It has not given a new start date; the registry still shows an old estimated start of June 2025.

No trial is enrolling yet. An earlier expanded access programme treated a small number of former trial participants; we found no programme open to new patients. BrainStorm's patient page lists trial information for anyone wanting to follow ENDURANCE.

• ENDURANCE (Phase 3b) (NCT06973629) not yet recruiting
• Phase 3 (completed) (NCT03280056) completed · USA