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NeuroSense Therapeutics intends to file a New Drug Submission (NDS) to Health Canada for PrimeC to treat amyotrophic…
NRSNWNeuroSense Therapeutics Ltd.
NeuroSense Therapeutics intends to file a New Drug Submission (NDS) to Health Canada for PrimeC to treat amyotrophic lateral sclerosis (ALS). The decision follows a constructive Pre-NDS meeting with Health Canada and is supported by Phase 2b PARADIGM clinical program data showing a 14.9-month median survival benefit (HR 0.35, p=0.0037) and achievement of the primary TDP-43 biomarker endpoint (p=0.0421). NeuroSense is a biotechnology company developing disease-modifying treatments for neurodegenerative diseases.