Israeli biotechnology company NeuroSense Therapeutics Ltd (Nasdaq: NRSN) announced on Tuesday a further update on its plans to file for early commercialisation approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy.

The submission is based on promising results from the company's Phase 2b ALS PARADIGM clinical trial, supported by additional clinical and preclinical data.

Dossier submission is planned for the second quarter of 2025, with a regulatory decision expected by the first quarter of 2026.

This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS.

NeuroSense anticipates a significant market opportunity in Canada, with potential peak annual revenue of USD100m to USD150m, driven by the prevalence of ALS in Canada, estimated market penetration of PrimeC, estimated price, and the current unmet demand for effective ALS treatments. After Canada, the company is planning to pursue regulatory approval in additional global markets.