NeuroSense's PrimeC Advances Toward Canadian Fast-Track Approval Following Health Canada Meeting

NeuroSense Therapeutics has achieved a critical regulatory milestone for its ALS treatment PrimeC following a productive pre-submission meeting with Health Canada that explored the drug's eligibility for Canada's fast-track approval pathway. The Notice of Compliance with Conditions pathway could significantly accelerate PrimeC's availability to Canadian patients suffering from amyotrophic lateral sclerosis, a progressive neurodegenerative disease with limited treatment options. This regulatory progress comes at a pivotal time for NeuroSense, as the company recently secured a binding term sheet with a global pharmaceutical partner that includes Phase 3 funding and milestone payments.

The Phase 2b trial results for PrimeC demonstrated compelling efficacy, showing a 36% slowdown in ALS disease progression and a 43% improvement in survival rates compared to standard care. These clinical outcomes highlight the drug's potential to address a significant unmet medical need in the ALS treatment landscape. The Canadian ALS market represents substantial commercial opportunity, with estimates suggesting $100–150 million in annual peak sales potential, making successful approval in Canada both clinically meaningful and strategically important for NeuroSense's broader commercial objectives.

Positive regulatory feedback from Health Canada could further validate PrimeC's clinical profile and strengthen NeuroSense's position in ongoing partnership discussions. The company anticipates receiving official meeting minutes from Health Canada shortly, which will provide detailed guidance on the regulatory pathway forward. This development positions NeuroSense at a crucial inflection point, with potential to not only bring a new treatment option to Canadian ALS patients but also to establish a strategic foundation for global expansion efforts in other key markets including the United States and Europe.