NeuroSense to meet with FDA for Phase 3 ALS trial and NDA submission

NeuroSense (NRSN) is scheduled for a Type C meeting with the FDA to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis, or ALS. The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Application submission, ensuring its regulatory strategy aligns with the FDA’s requirements. In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026. The company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100M-$150M in annual revenue. This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS.