NeuroSense Therapeutics announced plans on July 22, 2026, to file a New Drug Submission (NDS) with Health Canada for PrimeC. The company expects to complete the filing for its ALS treatment in the coming months. A constructive Pre-NDS meeting with the Canadian regulatory agency informed the decision.
Phase 2b PARADIGM clinical program data supports the filing. The trial demonstrated a significant long-term survival benefit for patients. PrimeC also met its primary TDP-43 biomarker endpoint.
PrimeC combines two previously approved drugs to treat amyotrophic lateral sclerosis (ALS). This regulatory step advances the late-stage biotech company toward potential commercialization.