Tuesday, August 11, 2026
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Pre-Application Process Has Been Completed. NeuroSense announced that it has completed Pre-NDS meetings with Health Canada and plans to submit a New Drug Submission (NDS) for PrimeC in its ALS indication. These meetings focused on whether the data could support approval and the submission requirements. The target date is December 2026. We see this as good news that is consistent with our expectations.
We View The Canadian NDS Process As An Important Milestone For PrimeC. The NDS application will include the Phase 2b PARADIGM trial data, with additional preclinical and supporting data. The primary endpoint in the trial showed a reduction in TDP-43 (TAR DNA-binding Protein 43, a protein that drives ALS progression and deterioration). The data also showed increased median survival, improved functional assessments, biomarkers showing slower disease progression, as well as safety and tolerability. Approval would be based on Health Canada’s analysis of these data.
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