Biopharma · FDA Approvals · Stock
NeuroSense Therapeutics Ltd is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. These diseases include Amyotrophic Lateral Sclerosis, or ALS, Alzheimer's disease, and Parkinson's disease, among others. Its produc…
Assets on file: PrimeC
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NeuroSense to Present PARADIGM-to-PARAGON Data at NEALS 2026
NeuroSense will present integrated clinical and biomarker findings from the PARADIGM Phase 2b trial of PrimeC in ALS at the NEALS 2026 annual meeting on October 30, 2026. The presentation will discuss how these data are informing the design of the planned PARAGON Phase 3 trial, for which the company has already received FDA clearance to proceed. This is a scientific conference presentation on prior results and upcoming trial strategy.
NeuroSense Files U.S. Patent for PrimeC in Traumatic Brain Injury
NeuroSense filed a U.S. patent application seeking protection for PrimeC in concussion, blast-related brain injury and CTE. This positions the asset for potential expansion beyond ALS into an indication with no approved disease-modifying therapies.
NeuroSense targets Dec 2026 Health Canada NDS for PrimeC in ALS
NeuroSense announced a targeted December 2026 New Drug Submission to Health Canada for PrimeC in ALS. It also expects a Q1 2027 decision on non-dilutive grant funding for the Phase 3 PARAGON trial. The company regained minimum bid price compliance and has a Nasdaq hearing scheduled for November 10, 2026.
NeuroSense Targets December 2026 NDS Filing for PrimeC in Canada for ALS
NeuroSense completed the Pre-NDS process with Health Canada and is now targeting submission of a New Drug Submission for PrimeC in ALS in December 2026. Health Canada aligned on content, structure and timeline with no concerns raised. This advances the Canadian regulatory pathway using the expanded PARADIGM clinical, survival and biomarker data package.
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