NeuroSense adds new ALS biomarker data to planned Canadian PrimeC submission
NRSN•NeuroSense Therapeutics moved its target for submitting PrimeC in Canada to March 2027 from December 2026 to include new ALS trial data. A newly disclosed analysis found PrimeC reduced a neuronal injury biomarker more than placebo, with stronger effects among participants with higher baseline functionality.
1. Submission timing and data
NeuroSense Therapeutics plans to submit PrimeC in Canada in March 2027, three months later than its previous target, to include new ALS trial data. The submission is to combine published Phase 2b PARADIGM results with the new analysis and additional unpublished trial data; statistical analyses are still underway.
2. Review and market
Health Canada raised no concerns about the revised timing, and its standard review target is approximately 300 calendar days after accepting a submission. The filing would be PrimeC’s first marketing application; the company estimates approximately 4,000 Canadians have ALS and approximately 1,000 new diagnoses occur annually.
