NeuroSense Therapeutics Ltd (NASDAQ:NRSN), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, announced on Thursday that it is targeting December 2026 for the filing of a New Drug Submission (NDS) with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis (ALS).

This target follows the successful finalisation of the Pre-NDS process with Health Canada and the associated meeting minutes. The discussions with Health Canada provided alignment regarding the content and structure of the submission. Health Canada has also indicated that it has no concerns with the company's proposed filing timeline and advised it to target early December.

The application will now undergo an administrative screening and, if accepted for review, a comprehensive scientific evaluation. Health Canada's target review timeline for a standard NDS is approximately 300 days following acceptance for review.

Based on publicly reported Canadian data, over 3,000 Canadians are currently living with ALS, and approximately 1,000 Canadians are diagnosed with the disease each year. Given the limited treatment options available and their modest clinical benefit, ALS remains a progressive and fatal neurodegenerative disease with substantial unmet medical need.

The planned NDS will be supported by the totality of evidence generated through NeuroSense's Phase 2b PARADIGM clinical program.

NeuroSense says that it is progressing the Canadian NDS in parallel with preparations for PARAGON, its confirmatory Phase 3 clinical study of PrimeC in ALS.