NeuroSense Therapeutics Ltd. announced that it has resumed its regulatory advancement in Canada for its lead ALS candidate PrimeC, following a productive discussion with Health Canada. The company is preparing for a pre‑New Drug Submission (pre‑NDS) meeting scheduled for April 2026 and expects a full NDS submission by mid‑2026 if the meeting is successful.
PrimeC’s progress is underpinned by the Phase 2b PARADIGM study, which showed a 33 % slowing of disease progression (p = 0.007) and a 58 % improvement in survival rates among ALS patients. These results provide a strong clinical foundation for the Canadian regulatory submission and support the company’s strategy of pursuing multiple jurisdictions simultaneously.
In addition to the Canadian pathway, NeuroSense has secured FDA clearance to launch its pivotal Phase 3 PARAGON trial in the United States. The parallel advancement of the Canadian and U.S. regulatory strategies demonstrates a robust development plan designed to accelerate patient access and maximize commercial potential across markets.
A successful NDS in Canada would allow PrimeC to enter a market that could generate peak annual revenues of $100 million to $150 million. This potential revenue stream is significant for a pre‑revenue company and represents a key milestone in translating clinical success into commercial impact.
NeuroSense remains a pre‑revenue, cash‑constrained biopharma company. As of December 31, 2024, it held approximately $3.4 million in cash, having raised $5 million in a private placement earlier that year. The company’s financial position underscores the importance of regulatory milestones in driving future funding needs and commercial viability.
CEO Alon Ben‑Noon said the positive engagement with Health Canada “reinforces confidence in the regulatory pathway” and highlighted the company’s commitment to delivering a disease‑modifying therapy for ALS patients. He emphasized that the Phase 2b data “strongly support advancing PrimeC toward a Phase 3 study” and that the Canadian submission is a critical step toward broader patient access.
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