EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission

Benzinga10-28

NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for ...

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(NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for ...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-nano-cap-neurosense-schedules-120019099.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-10-28 20:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/exclusive-nano-cap-neurosense-schedules-120019099.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for ...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-nano-cap-neurosense-schedules-120019099.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"NRSN","symbol_name":"Neurosense Therapeutics Ltd","start_time":0,"source_url":"https://finance.yahoo.com/news/exclusive-nano-cap-neurosense-schedules-120019099.html","article_id":"2478104925","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/u4NWUt.HM1ihP5r3gFR6gQ--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/08141a052051023589396aa79a4ceefd"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2478104925","pubTimestamp":1730116819,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"NeuroSense Therapeutics Ltd.  on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis .ALS isa fatal type of motor neuron disease. It causes progressive degeneration of nerve cells in the spinal cord and brain.The FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug.NeuroSense will also review its readiness for a future New Drug Application  submission, ensuring its regulatory strategy aligns with the FDA's requirements.NeuroSense plans to give an update on the meeting results following receipt of the meeting minutes, which are expected approximately one month after the meeting.PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in clinical and biological markers of disease prog","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"NRSN":"Neurosense Therapeutics Ltd","BK4139":"生物科技","NRSNW":"NeuroSense Therapeutics Equity Warrant Exp 9th Nov 2026 Warrant"},"translate_title":"独家：Nano-Cap NeuroSense安排FDA会议以推进主导计划和营销申请提交","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NRSN":0.9,"NRSNW":0.9},"content_text":"NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS).\nALS is a fatal type of motor neuron disease. It causes progressive degeneration of nerve cells in the spinal cord and brain.\nThe FDA Type C meeting, scheduled for November 6, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug.\nNeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements.\nNeuroSense plans to give an update on the meeting results following receipt of the meeting minutes, which are expected approximately one month after the meeting.\nPrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in clinical and biological markers of disease progression.\nIn parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026.\nThe company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue.\nThe decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo.\nIn August, NeuroSense Therapeutics said it was in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize PrimeC.\nIn July, 12-month data of the PARADIGM Phase 2b study showed a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo.\nSpecifically, the intent to treat analysis at 12 months revealed a difference of 6.5 points in the ALSFRS-R, representing a 36% improvement and a statistically significant P value of 0.009.\nPrice Action: NRSN stock is down 5.51% at $1.20 during the premarket session at last check Monday.\nRead Next:\n\nL3Harris Poised For 2025 Growth: Analysts Highlight Q3 Earnings Beat, Solid Orders, And Margin Expansion Potential\n\nUNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets.\nGet the latest stock analysis from Benzinga?\n\nThis article EXCLUSIVE: Nano-Cap NeuroSense Schedules FDA Meeting To Advance Lead Program And Marketing Application Submission originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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