NeuroSense Therapeutics announced a scheduled Type C meeting with FDA on November 6, 2024, to finalize the design of its Phase 3 clinical trial for PrimeC, a potential ALS treatment. The meeting will also address NDA submission readiness, with meeting minutes expected approximately one month later.The company's lead product PrimeC has demonstrated significant results in clinical trials, including a 37.4% reduction in disease progression (p=0.03) compared to placebo in the Phase 2b PARADIGM trial. The drug has received Orphan Drug Designation from both FDA and EMA, showing promise as a breakthrough therapy for ALS.In parallel developments, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The company estimates the potential Canadian market opportunity at $100-150 million in annual revenue, supported by clinical findings showing PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% versus placebo.

NeuroSense Therapeutics announced a scheduled Type C meeting with FDA on November 6, 2024, to finalize the design of its Phase 3 clinical trial for PrimeC, a potential ALS treatment. The meeting will also address NDA submission readiness, with meeting minutes expected approximately one month later.The company's lead product PrimeC has demonstrated significant results in clinical trials, including a 37.4% reduction in disease progression (p=0.03) compared to placebo in the Phase 2b PARADIGM trial. The drug has received Orphan Drug Designation from both FDA and EMA, showing promise as a breakthrough therapy for ALS.In parallel developments, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. The company estimates the potential Canadian market opportunity at $100-150 million in annual revenue, supported by clinical findings showing PrimeC reduced disease progression (p=0.009) and improved survival rates by 43% versus placebo.