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NeuroSense Therapeutics completed its Pre-New Drug Submission (Pre-NDS) process with Health Canada for PrimeC, its…
NRSNNeuroSense Therapeutics Ltd.
NeuroSense Therapeutics completed its Pre-New Drug Submission (Pre-NDS) process with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis (ALS). The company has aligned with the regulator on submission content and structure, targeting an early December 2026 filing. Health Canada indicated no concerns with this timeline. PrimeC is supported by Phase 2b PARADIGM data showing a ~15-month median survival benefit and biomarker improvements. NeuroSense is also preparing for its confirmatory Phase 3 PARAGON trial in the U.S. The company operates as a late-stage clinical biotechnology firm developing disease-modifying treatments for neurodegenerative diseases.