Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026

Reuters10-14

Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026

Rocket Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), an investigational gene therapy for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 28, 2026, for its decision. This BLA resubmission is supported by positive clinical data showing 100% overall survival at 12 months post-infusion among treated patients. If approved, Rocket Pharmaceuticals may be eligible for a Rare Pediatric Disease Priority Review Voucher. No grant or funding announcement involving multiple organizations was disclosed.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rocket Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251013059069) on October 14, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2575149291?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-10-14 19:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2575149291","market":"us","top_or_hot":-1,"title":"Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Rocket Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), an investigational gene therapy for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 28, 2026, for its decision. This BLA resubmission is supported by positive clinical data showing 100% overall survival at 12 months post-infusion among treated patients. If approved, Rocket Pharmaceuticals may be eligible for a Rare Pediatric Disease Priority Review Voucher. No grant or funding announcement involving multiple organizations was disclosed.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rocket Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251013059069) on October 14, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"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>Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026</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\">\nRocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-10-14 19:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Rocket Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), an investigational gene therapy for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 28, 2026, for its decision. This BLA resubmission is supported by positive clinical data showing 100% overall survival at 12 months post-infusion among treated patients. If approved, Rocket Pharmaceuticals may be eligible for a Rare Pediatric Disease Priority Review Voucher. No grant or funding announcement involving multiple organizations was disclosed.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rocket Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251013059069) on October 14, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251014:nNDLccl7qd:1","article_id":"2575149291","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2575149291","pubTimestamp":1760439657,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026. Rocket Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration  has accepted the resubmission of the Biologics License Application  for KRESLADI , an investigational gene therapy for the treatment of severe Leukocyte Adhesion Deficiency-I . The FDA has set a Prescription Drug User Fee Act  date of March 28, 2026, for its decision. This BLA resubmission is supported by positive clinical data showing 100% overall survival at 12 months post-infusion among treated patients. If approved, Rocket Pharmaceuticals may be eligible for a Rare Pediatric Disease Priority Review Voucher. No grant or funding announcement involving multiple organizations was disclosed.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-g","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","RCKT":"Rocket Pharmaceuticals, Inc."},"translate_title":"Rocket Pharmaceuticals宣布FDA接受KRESLADI的BLA重新提交™严重LAD-I的基因治疗；PDUFA日期定在2026年3月","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RCKT":0.9},"content_text":"Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for KRESLADI™ Gene Therapy for Severe LAD-I; PDUFA Date Set for March 2026\n    \n\n        Rocket Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel), an investigational gene therapy for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 28, 2026, for its decision. This BLA resubmission is supported by positive clinical data showing 100% overall survival at 12 months post-infusion among treated patients. If approved, Rocket Pharmaceuticals may be eligible for a Rare Pediatric Disease Priority Review Voucher. No grant or funding announcement involving multiple organizations was disclosed.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rocket Pharmaceuticals Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251013059069) on October 14, 2025, and is solely responsible for the information contained therein.","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,"symbols":[],"gpt_button":0,"need_auth":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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","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/2575149291","isCrawlerRequest":true}