NeuroSense Therapeutics (NRSN) said Monday it is scheduled for a type C meeting with the US Food and Drug Administration Nov. 6 to discuss the design of a phase 3 clinical trial for its lead drug candidate PrimeC for the potential treatment of amyotrophic lateral sclerosis.
The company plans to provide an update on meeting results after receiving the meeting minutes, which are expected roughly one month after the event, it said.
NeuroSense also said it plans to submit its regulatory dossier to Health Canada in Q2, with a regulatory decision expected by Q1 2026.
ALS is an incurable neurodegenerative disease that causes complete paralysis and death within two to five years from diagnosis, the company said. NeuroSense said its PrimeC has shown 'promising' results in clinical trials, including a statistically significant reduction in disease progression clinical and biological markers.
NeuroSense shares were up 3.2% in recent Monday trading.
Price: 1.31, Change: +0.04, Percent Change: +3.15
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