NeuroSense Therapeutics Ltd. operates as a biotechnology firm in the clinical development phase, committed to discovering and developing effective therapies for individuals suffering from severe neurodegenerative conditions. The company's leading drug candidate, PrimeC, is an innovative oral formulation that has successfully concluded Phase IIa clinical investigations for the management of amyotrophic lateral sclerosis (ALS). Additionally, its early-stage research pipeline features StabiliC, a potential treatment for Parkinson's disease, and CogniC, which is under development for Alzheimer's disease. Established in 2017, NeuroSense Therapeutics Ltd. is headquartered in Herzliya, Israel.
NeuroSense Completes PrimeC Pre-NDS Process and Advances Toward December 2026 Filing with Health Canada
NeuroSense completed the Pre-NDS process with Health Canada for its ALS therapy PrimeC, targeting a December 2026 filing for the New Drug Submission. Health Canada aligned on the content and structure of the submission and indicated no concerns with the proposed timeline.
The filing will be supported by Phase 2b data from the PARADIGM program, which demonstrated a statistically significant ~15-month median survival benefit.
Standard review for a standard NDS in Canada is approximately 300 days, while NeuroSense continues preparations for the Phase 3 PARAGON trial in parallel.