NeuroSense Schedules Key FDA Meeting, On Track to Advance Phase 3 ALS Trial and NDA Submission

NeuroSense Therapeutics Ltd. (NASDAQ : NRSN) has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) on November 6, 2024, to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). The meeting will focus on finalizing the Phase 3 study design and assessing readiness for a future New Drug Application (NDA) submission. NeuroSense plans to provide an update on the meeting results after receiving the official minutes, expected approximately one month later.

PrimeC has shown promising results in earlier clinical trials, including a reduction in disease progression. Concurrently, NeuroSense is preparing to submit a regulatory dossier to Health Canada in Q2 2025, with a potential commercialization decision anticipated by Q1 2026. The company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue.