NeuroSense Advances ALS Drug Development, Prepares for Canadian Regulatory Filing

NeuroSense Therapeutics Ltd. has provided an update on its business progress for the first half of 2026, with a focus on advancing its investigational combination therapy, PrimeC, for amyotrophic lateral sclerosis (ALS) through regulatory pathways in the United States and Canada.

CEO Alon Ben-Noon stated that advancing PrimeC towards its next stage of development and ultimately to patients remains a primary objective. NeuroSense is working to move its development plans forward in a capital-efficient manner, pursuing regulatory, clinical, financing, and strategic opportunities. Future priorities include advancing the Canadian regulatory pathway, preparing for the next clinical stage of PrimeC in ALS, and seeking financing, partnerships, and strategic alternatives to support the program's continued development.

The company is targeting a New Drug Submission (NDS) filing in Canada for PrimeC in December 2026, following the completion of a Pre-NDS process and discussions with Health Canada, which indicated alignment on the proposed timeline and submission content. In the U.S., NeuroSense is working towards an optimized, capital-efficient development strategy. This includes plans for an active-comparator study against edaravone and evaluation of a potentially smaller, shorter pivotal PARAGON design. The company intends to discuss with the FDA whether existing data may support full or accelerated approval.

Key developments in the first half of 2026 include the publication of results from the PrimeC PARADIGM study in JAMA Neurology in March 2026, providing peer-reviewed validation of its clinical and biological activity. Long-term follow-up reported in February 2026 showed a 65% reduction in the risk of death for patients on continuous PrimeC treatment. In June 2026, the company announced that the PARADIGM study achieved its primary endpoint, demonstrating a statistically significant reduction in extracellular vesicle-associated TDP-43, a biomarker present in over 97% of ALS cases. NeuroSense also advanced its Alzheimer's program and strengthened its intellectual property portfolio.