RegulatoryAug 6, 2026, 12:06 PM
NeuroSense Targets Dec 2026 for PrimeC ALS Drug Filing with Health Canada
AI Summary
NeuroSense Therapeutics announced its target of December 2026 for filing a New Drug Submission (NDS) with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis (ALS). This follows the successful finalization of the Pre-NDS process, where Health Canada aligned with the company on the planned content and structure of the submission. The company highlighted the significant unmet medical need for additional ALS treatments in Canada and the supporting clinical evidence from its Phase 2b PARADIGM study.
Key Highlights
- Targeting December 2026 for PrimeC New Drug Submission (NDS) filing with Health Canada.
- Completed Pre-NDS process, achieving alignment with Health Canada on submission content.
- Health Canada indicated no concerns with the proposed filing timeline.
- NDS is the Canadian equivalent of a US New Drug Application (NDA).
- Planned NDS supported by Phase 2b PARADIGM data, showing ~15-month median survival benefit.
- Canada has over 3,000 ALS patients and 1,000 new diagnoses annually.
- Company is also preparing for the confirmatory Phase 3 PARAGON clinical study.
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