EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission

NeuroSense Therapeutics Ltd. NRSN on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS).

ALS is a fatal type of motor neuron disease. It causes progressive degeneration of nerve cells in the spinal cord and brain.

The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug.

NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements.

NeuroSense plans to give an update on the meeting results following receipt of the meeting minutes, which are expected approximately one month after the meeting.

PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in clinical and biological markers of disease progression.

In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026.

The company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue.

The decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.

In August, NeuroSense Therapeutics said it was in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize PrimeC.

In July, 12-month data of the PARADIGM Phase 2b study showed a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo.

Specifically, the intent to treat analysis at 12 months revealed a difference of 6.5 points in the ALSFRS-R, representing a 36% improvement and a statistically significant P value of 0.009.

Price Action: NRSN stock is down 5.51% at $1.20 during the premarket session at last check Monday.

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