NeuroSense outlines redesigned PrimeC development plan
NeuroSense outlined a redesigned development plan for PrimeC in ALS, aiming to speed a regulatory filing while cutting overall development costs.
Phase 2b PARADIGM results were already reported, supporting the program with signs of clinical benefit, biomarker changes, and longer-term survival trends.
Next steps include an active-comparator trial versus edaravone, seeking clearer differentiation to support commercial positioning with physicians and payers.
A smaller, shorter Phase 3 PARAGON design is under review, with FDA discussions planned on full approval versus accelerated approval.
Canada filing targeted for December 2026, which could bring earlier market access based on existing data if accepted and approved.
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