RegulatoryJul 22, 2026, 08:42 AM
NeuroSense to File New Drug Submission for PrimeC ALS Treatment in Canada
AI Summary
NeuroSense Therapeutics announced its intention to file a New Drug Submission (NDS) with Health Canada for PrimeC, its lead product candidate for treating amyotrophic lateral sclerosis (ALS). This decision follows a constructive Pre-NDS meeting with the agency and is supported by additional data from the Phase 2b PARADIGM clinical program. The data includes achievement of the primary TDP-43 biomarker endpoint and a significant 14.9-month median survival benefit.
Key Highlights
- NeuroSense plans to file a New Drug Submission (NDS) for PrimeC with Health Canada for ALS treatment.
- The decision follows a constructive Pre-NDS meeting and alignment with Health Canada on the NDS pathway.
- Submission is supported by additional data from the Phase 2b PARADIGM study.
- Study achieved the prespecified primary TDP-43 biomarker endpoint (p=0.0421).
- Demonstrated a 14.9-month median survival benefit (HR 0.35 and p=0.0037).
- NeuroSense expects to complete and file the submission in the coming months.
- The company has also received US FDA clearance to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS.
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