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NeuroSense Therapeutics (NASDAQ: NRSN)* has completed a key pre-submission meeting with Health Canada for its ALS drug PrimeC, signaling potential upcoming eligibility for Canada’s fast-track approval pathway (NOC/c). The positive tone reported from the meeting could signal accelerated Canadian approval coming soon and could also potentially advance negotiations for the partnership with a global pharma player. With strong Phase 2b data and a potential $100–150M of peak revenue from Canadian market alone, this milestone could be a catalyst for regulatory momentum and investor revaluation.
NeuroSense Therapeutics (NASDAQ: NRSN) may be nearing a turning point in its ALS drug development journey, and the market is starting to take notice. The Israeli biotech just disclosed that it held a pivotal pre-submission meeting with Health Canada for PrimeC, its lead ALS candidate, potentially setting the stage for both early approval and the finalization of a major pharma partnership.
In a Form 6-K filed with the SEC, NeuroSense confirmed the completion of a pre-New Drug Submission (pre-NDS) meeting with regulators to explore eligibility for Canada’s fast-track approval mechanism, known as the Notice of Compliance with Conditions (NOC/c). The company described the discussion as “constructive” and left the meeting “highly encouraged”, language that signals regulatory alignment and opens the door for PrimeC to potentially Canadian patients much sooner than expected.
For ALS patients in Canada—and a company with a current ~$52 million valuationm that kind of timeline could prove transformational.
But the Health Canada development is more than just a regulatory checkpoint—it’s a potential trigger for something bigger. Back in December 2024, NeuroSense signed a binding term sheet with a global pharmaceutical company, covering full Phase 3 funding, upfront cash, milestone payments, and double-digit royalties. A positive signal from Canadian authorities could be the validation needed to cement that deal and set the stage for global expansion.
PrimeC already has data to back up its ambitions. In its Phase 2b PARADIGM trial, the therapy showed a 36% slowdown in ALS progression and a 43% improvement in survival compelling outcomes in a field where treatment options are few and efficacy gains are hard-won. That performance is part of what’s drawing interest from the industry—and why a Canadian approval could serve as a powerful launchpad, both commercially and strategically.
The Canadian ALS market alone could support $100–150 million in annual peak sales, according to company estimates. But what’s arguably more valuable is the opportunity to generate real-world data and establish market traction ahead of broader approvals, particularly in the U.S. and Europe.
Investors likely won’t have to wait long for clarity. NeuroSense expects to receive official meeting minutes from Health Canada shortly and will update the market once eligibility is confirmed. If successful, the NDS filing and Phase 3 launch would likely follow.
In a sector defined by long timelines and uncertain outcomes, NeuroSense now finds itself in a rare position, with validated clinical data, regulatory momentum, and a pending global partnership that could reprice the story entirely. The next few months may determine whether PrimeC becomes not only a commercial product, but also a cornerstone of a much larger biotech success.
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