FDA Rejection Sparks Questions On Replimune Drug Approval Path

Benzinga_recent_news04-14

Replimune Group Inc. (NASDAQ:REPL) on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application. The application sought approval...

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(NASDAQ:REPL) on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application.\nThe application sought approval...</p>\n\n<a href=\"https://www.benzinga.com/analyst-stock-ratings/downgrades/26/04/51788005/fda-rejection-sparks-questions-on-replimune-drug-approval-path\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_news","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>FDA Rejection Sparks Questions On Replimune Drug Approval Path</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\">\nFDA Rejection Sparks Questions On Replimune Drug Approval Path\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-04-14 01:44 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/analyst-stock-ratings/downgrades/26/04/51788005/fda-rejection-sparks-questions-on-replimune-drug-approval-path><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Replimune Group Inc. (NASDAQ:REPL) on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application.\nThe application sought approval...</p>\n\n<a href=\"https://www.benzinga.com/analyst-stock-ratings/downgrades/26/04/51788005/fda-rejection-sparks-questions-on-replimune-drug-approval-path\">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":"LU1815336091.USD","symbol_name":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) INC","start_time":0,"source_url":"https://www.benzinga.com/analyst-stock-ratings/downgrades/26/04/51788005/fda-rejection-sparks-questions-on-replimune-drug-approval-path","article_id":"2627506734","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/04/13/Motala--Sweden--7-January-2023-Fda-Logo-.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/analyst-stock-ratings/downgrades/26/04/51788005/fda-rejection-sparks-questions-on-replimune-drug-approval-path","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2627506734","pubTimestamp":1776102240,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Replimune gets FDA CRL for RP1 melanoma therapy, disputes review process as analysts cut ratings and price targets sharply.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1815336091.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) INC","BK4121":"生命科学工具和服务","CRL":"查尔斯河","BK4530":"医药外包概念","REPL":"Replimune Group Inc.","BK4139":"生物科技","IE00BFMHRM44.USD":"NEUBERGER BERMAN GLOBAL EQUITY MEGATRENDS \"A\" (USD) ACC","BK4588":"碎股","LU0128526141.USD":"TEMPLETON GLOBAL SMALLER COMPANIES \"A\" ACC","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","LU0757428866.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AE\" (USD) ACC","LU0029874061.USD":"TEMPLETON GLOBAL SMALLER COMPANIES \"A\" YDIS INC","LABU":"三倍做多标普生物-Direxion","BK4585":"ETF&股票定投概念"},"translate_title":"FDA的拒绝引发了人们对Replimune药物审批路径的质疑","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LABU":1.5,"CRL":1,"REPL":1},"content_text":"Replimune Group Inc. (NASDAQ:REPL) on Friday received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application.\nThe application sought approval of RP1 in combination with nivolumab for advanced melanoma, challenging the agency's assessment of its data package.\nThe company argued that the dataset supporting its breakthrough therapy designation should have been sufficient for accelerated approval, pointing to results from the IGNYTE trial.\nIn that study, patients who had progressed on prior anti-PD-1 therapies showed a 34% response rate when treated with RP1 plus nivolumab, with a median duration of response of 24.8 months and a favorable safety profile.\nReplimune highlighted what it described as inconsistencies in the FDA's review process. According to the company, a new review team was assigned during the resubmission phase, replacing the original team that had engaged with the company earlier.\nThe company also noted that the new team did not meet with management during the review, despite outreach efforts. It further pointed to prior statements from a senior reviewer indicating that the clinical team had supported the evidence package, though leadership disagreed.\nReplimune said the CRL contradicts earlier FDA feedback, particularly from a September 2025 Type A meeting.\nAt that time, the agency had not raised additional concerns about patient heterogeneity and acknowledged challenges in conducting randomized trials in this setting.\nThe company also submitted additional analyses, including data showing median progression-free survival of 30.6 months with RP1 plus nivolumab versus 4.4 months on prior therapies.\nIt claims the FDA did not respond to requests for feedback before accepting the resubmission.\nHC Wainwright downgraded Replimmune from Buy to Sell. Analyst Robert Burns sees a significantly longer path for RP-1 to reach the market, if at all.\n\"It may take until late in this decade to furnish the agency with the data that it appears to be demanding. There can be no assurance that Replimune would be able to accomplish this. As such, the company is facing a significant crisis and may not be able to pivot successfully,\" Burns added.\nJefferies also downgraded Replimune from Buy to Hold and lowered the price forecast from $13 to $2.\nWedbush downgrades Replimune from Outperform to Neutral and lowers the price target from $19 to $2.\nJP Morgan shifted its rating from Neutral to Underweight.\nLeerink Partners downgraded Replimune from Outperform to Market Perform and lowered the price target from $11 to $2.\nCantor Fitzgerald also downgrades Replimune from Overweight to Neutral.\nREPL Price Action: Replimune Group shares were down 63.97% at $1.71 at the time of publication on Monday. The stock is trading at a new 52-week low, according to Benzinga Pro data.\nImage via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2627506734","isCrawlerRequest":true}