Roth Capital Partners analyst Boobalan Pachaiyappan says Neurosense Therapeutics (Neurosense Therapeutics Stock Quote, Chart, News, Analysts, Financials NASDAQ:NRSN) has reduced regulatory uncertainty for PrimeC in Canada, though financing remains an investor concern.
In a July 23 update, Pachaiyappan mainained his “Buy” rating and $3.00 price target on NRSN. He said Neurosense has aligned with Health Canada on a potential New Drug Submission pathway for PrimeC, its ALS drug candidate.
Despite the update, Neurosense shares fell 7%, compared with a 2% decline for the XBI biotech index, suggesting investors remain focused on the company’s financial constraints.
Pachaiyappan said PrimeC’s optionality has improved, helped by new TDP-43 biomarker data. In the Phase 2b PARADIGM study, PrimeC showed about 33% disease slowing and a 58% survival improvement, while the new biomarker data showed a statistically significant reduction.
He said the Health Canada update materially reduces regulatory uncertainty and improves the chances of a December filing, with potential approval in the second half of 2027 if the accelerated pathway is used.
Pachaiyappan said Canada has about 3,000 to 4,000 ALS patients. Assuming 25% peak penetration and annual pricing of $200,000, he said PrimeC could generate about $200-million in Canadian revenue if self-commercialized.
He said the update could also help attract strategic partners for Canadian commercialization.
Still, Pachaiyappan said the announcement left several questions unanswered, including whether the submission would qualify for accelerated or full approval, how the company will finance the filing and future Phase 3 work, and whether PrimeC will be commercialized directly or through a partner.
“However, a key point worth mentioning is that PrimeC could be approved first in Canada,” Pachaiyappan said.
The analyst said a Canadian approval could generate real-world evidence that may be viewed favourably by other regulators, including the U.S. The FDA has already aligned with Neurosense on the design of its Phase 3 study, which is expected to begin in the second half of 2026.
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