NeuroSense shares surge 10.38% after-hours after FDA clears pivotal Phase 3 ALS trial for PrimeC.

NeuroSense surged 10.38% in after-hours trading following the U.S. Food and Drug Administration’s clearance to initiate its pivotal Phase 3 PARAGON trial for PrimeC, a novel combination therapy for amyotrophic lateral sclerosis (ALS). The FDA’s authorization allows the company to begin enrolling 300 patients in a global, double-blind, 12-month trial with a 2:1 randomization ratio (PrimeC vs. placebo) and an open-label extension. This milestone, building on promising Phase 2b results, positions NeuroSense to advance its lead candidate toward potential regulatory approval for a disease with significant unmet medical need. The trial’s adaptive design and high statistical power (>95%) further underscore its strategic importance, driving optimism among investors about the company’s pipeline progress.