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NeuroSense to Hold Pre-NDS Meeting with Health Canada in April 2026
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada ("Agency"), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada ("Agency"), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).","length":450,"tagName":"p"},{"type":"image","alt":"NeuroSense Logo","displaySize":"","headline":null,"caption":"NeuroSense Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":160,"url":"https://media.zenfs.com/en/prnewswire.com/488fd1dd822c4adae2c61a5f94250e7d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MN2mGlFDOSbLhtTMpnwDsg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI4MjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/488fd1dd822c4adae2c61a5f94250e7d","width":400,"height":160}}},{"type":"text","content":"After outlining the remaining requirements, Health Canada confirmed that NeuroSense's proposed next steps align with the Agency's expectations. With additional clinical data recently generated and further supportive analyses underway, NeuroSense is now preparing for a pre-NDS meeting with Health Canada currently contemplated in April 2026.","length":349,"tagName":"p"},{"type":"text","content":"Pending a successful outcome of this meeting and completion of the final submission components, the Company currently anticipates a potential NDS submission by mid-2026.","length":169,"tagName":"p"},{"type":"text","content":""This positive engagement reinforces our confidence in the regulatory pathway in Canada," said Alon Ben-Noon, Chief Executive Officer of NeuroSense. "We appreciate the constructive dialogue with Health Canada as we work to bring PrimeC to people living with ALS."","length":283,"tagName":"p"},{"type":"text","content":"Additional details regarding the Canadian submission and contemplated timelines will be provided during NeuroSense's upcoming investor webinar on December 8th, 2025. Registration for the webinar is available here.","length":222,"tagName":"p"},{"type":"text","content":"About ALS","length":9,"tagName":"p"},{"type":"text","content":"Amyotrophic lateral sclerosis ("ALS") is ...