NeuroSense to Strengthen PrimeC Canadian ALS Submission With New NfL Data
PR Newswire•02/11/2026•09:00 ET
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Key Highlights
- ➤March 2027 Health Canada filing target replaces NeuroSense’s previously planned December 2026 timetable
- ➤PrimeC-treated participants showed greater NfL reductions than placebo in new Phase 2b analysis
- ➤PrimeC’s Canadian submission would be its first marketing application in any jurisdiction
- ➤Health Canada’s standard NDS review target is approximately 300 calendar days
- ➤PrimeC could address approximately 4,000 Canadians living with ALS if approved
Expert Statements
Alon Ben-Noon, Chief Executive Officer of NeuroSense
“Neurofilament light chain is one of the most widely used measures of neuronal injury in ALS, and adding this analysis to the PARADIGM results gives Health Canada a broader body of evidence on which to evaluate PrimeC's potential benefit for people living with ALS.”
Alon Ben-Noon, Chief Executive Officer of NeuroSense
“Canada is our nearest path to patients, and our priority is to submit the most complete application we can. In parallel, we are preparing for the FDA-cleared U.S. Phase 3 PARAGON trial.”
NeuroSense to Strengthen PrimeC Canadian ALS Submission With New NfL Data PR Newswire
Expanded package to include new neurofilament light chain (NfL) analysis; Health Canada confirms March 2027 filing timeline
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