NeuroSense targets faster, lower-cost ALS approval path for PrimeC under revamped development plan
NRSN•Revamped development plan for PrimeC
NeuroSense outlined an accelerated, lower-cost development plan to move PrimeC toward a potential ALS approval.
The strategy centers on three shorter studies to support an earlier regulatory submission than a single large confirmatory trial.
Planned work includes AI-based modeling to quantify PrimeC’s formulation advantage, supporting differentiation and potential added patent protection.
An active-comparator trial is planned to test PrimeC directly against edaravone to sharpen clinical and commercial positioning.
Canada track targets a New Drug Submission in December 2026, aiming for earlier access based on existing data.
