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NeuroSense Therapeutics Announces Successful Completion of Commercial Manufacturing Scale-Up for PrimeC in Preparation for Potential Canadian Market Launch
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a $100-150M Canadian Market Opportunity","length":182,"tagName":"p","attribs":{}},{"type":"text","content":"CAMBRIDGE, Mass., May 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.","length":507,"tagName":"p"},{"type":"image","alt":"NeuroSense Therapeutics Logo","displaySize":"","headline":null,"caption":"NeuroSense Therapeutics 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":"NeuroSense has strategically bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements that positions the company for a robust and expeditious commercial launch. The company has established a resilient manufacturing infrastructure supply chain by fully qualifying U.S. and Canadian Drug Master File (DMF) and Certificate of Suitability (CEP) holders for both of its Active Pharmaceutical Ingredients (APIs). These steps enable dependable and compliant sourcing for commercial-scale production volumes.","length":558,"tagName":"p"},{"type":"text","content":"Additionally, the Company is pleased to report that it is partnering with a global Contract Development and Manufacturing Organization (CDMO) that currently manufactures PrimeC clinical batches and will also support its future commercial supply. All analytical methods supporting drug product release and stability have been fully validated, and the manufacturing process has been successfully scaled to commercia...