NeuroSense reschedules Health Canada meeting to include additional data

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced it has rescheduled a pre-New Drug Submission meeting with Health Canada to May 2026 to include additional clinical, biomarker and survival data in its briefing package for PrimeC, its lead drug candidate.

The company said the decision was made to strengthen the scientific and clinical foundation supporting PrimeC. NeuroSense continues to pursue PrimeC under Canada's NOC/c pathway, which facilitates earlier access to therapies for serious unmet medical needs.

The company expects to report clinical and biomarker results from its Alzheimer's disease study in the coming weeks. NeuroSense previously reported a statistically significant survival benefit showing a 65% reduction in risk of death and received FDA clearance to initiate the pivotal Phase 3 PARAGON trial in amyotrophic lateral sclerosis (ALS).

PrimeC is an oral formulation combining ciprofloxacin and celecoxib, both FDA-approved drugs. The combination targets multiple mechanisms associated with ALS and Alzheimer's disease, including neuron degeneration, inflammation, iron accumulation and impaired RNA regulation.

"Our objective is to present the most comprehensive and robust dataset possible to Health Canada, thereby maximizing the likelihood of a constructive and efficient regulatory pathway," said Alon Ben-Noon, Chief Executive Officer of NeuroSense.

NeuroSense is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases. The company's strategy involves developing combined therapies targeting multiple pathways associated with these conditions.

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