Neurosense Therapeutics Ltd（NRSN）資訊與事件NRSNNeurosense Therapeutics Ltd

NeuroSense Delays PrimeC New Drug Submission to March 2027

NeuroSense plans to incorporate newly generated data into its New Drug Submission to Health Canada for PrimeC, its lead investigational therapy for amyotrophic lateral sclerosis, or ALS. The NDS would be PrimeC's first marketing application in any jurisdiction, and the company believes the additional data will strengthen the application and expand the evidence available for regulatory review. The March 2027 filing target updates the previously announced December 2026 timetable, allowing the additional data to be included. Health Canada has confirmed it has no concerns with the revised timing. In the new analysis, PrimeC-treated participants demonstrated a greater reduction in NfL compared to placebo, with an even more pronounced effect observed in participants with higher baseline functionality. Additional statistical analyses are underway to further characterize these findings and support their incorporation into the planned submission to Health Canada. Following acceptance of the NDS for review, Health Canada's standard review target for an NDS is approximately 300 calendar days.

NeuroSense Files Patent for Traumatic Brain Injury Treatment

NeuroSense Therapeutics announced that it has filed a patent application with the U.S. Patent and Trademark Office covering methods of treating traumatic brain injury, or TBI, and related central nervous system injuries with the combination of ciprofloxacin and celecoxib, the active ingredients of PrimeC. The application covers the treatment of a broad range of brain injuries, from concussion and mild TBI to moderate and severe TBI, including blast-related injury, as well as their long-term consequences, such as chronic traumatic encephalopathy. If granted, the patent is expected to provide protection through 2047, subject to any extensions. Traumatic brain injury represents a major global healthcare challenge, affecting millions of people each year. TBI can result from falls, motor vehicle accidents, sports-related injuries and military-related trauma, including blast exposure. Its consequences can extend well beyond the initial event, potentially causing persistent cognitive, physical and behavioral impairment, with substantial burdens on patients, caregivers and healthcare systems.

NeuroSense Unveils Redesigned Development Plan for PrimeC

NeuroSense Therapeutics announced a redesigned development plan for PrimeC in amyotrophic lateral sclerosis, structured to reach a potential path for regulatory submission and approval faster and at materially lower cost than the Company's previously planned development path. "One of the hardest constraints in ALS is not scientific - it is that the standard development path takes longer than patients have," said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. "We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer. It is faster, it costs less, and it produces a stronger package - pharmacology, comparative clinical context, and a pivotal dataset - than the single-trial approach would have."