Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection

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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\">\nScholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-09-23 23:32 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/25/09/47822434/scholar-rocks-spinal-muscular-atrophy-drug-faces-fda-delay-over-catalent-indiana-inspection><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s SRRK apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA)...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/09/47822434/scholar-rocks-spinal-muscular-atrophy-drug-faces-fda-delay-over-catalent-indiana-inspection\">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":"BK4215","symbol_name":"住宅房地产投资信托","start_time":0,"source_url":"https://www.benzinga.com/news/fda/25/09/47822434/scholar-rocks-spinal-muscular-atrophy-drug-faces-fda-delay-over-catalent-indiana-inspection","article_id":"2569288711","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/09/23/Muscular-Dystrophy.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/25/09/47822434/scholar-rocks-spinal-muscular-atrophy-drug-faces-fda-delay-over-catalent-indiana-inspection","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2569288711","pubTimestamp":1758641520,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"FDA cites Catalent Indiana issues in Scholar Rock's SMA drug review; European approval decision expected in 2026, with Germany as the launch market.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4215":"住宅房地产投资信托","CTLT":"Catalent","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","BK4588":"碎股","BK4217":"自存仓储房地产信托","CRL":"查尔斯河","LU0757428866.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AE\" (USD) ACC","MAA":"MAA房产信托","BK4007":"制药","BK4585":"ETF&股票定投概念","BK4121":"生命科学工具和服务","SMA":"Smartstop Self Storage REIT Inc","BK4530":"医药外包概念","LU1815336091.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) INC"},"translate_title":"Scholar Rock的脊髓性肌萎缩症药物因印第安纳州康泰伦特检查而面临FDA延迟","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CRL":1,"SMA":1,"MAA":1,"CTLT":1.5},"content_text":"The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s SRRK apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).\nThe CRL is related to observations identified during a routine general site inspection of Catalent Indiana LLC, a third-party fill-finish facility which Novo Nordisk A/S NVS acquired in December 2024.\nThe observations are not specific to apitegromab.\nThe CRL did not cite any other approvability concerns, including apitegromab’s efficacy and safety data or the third-party drug substance manufacturer.\nAlso Read: Scholar Rock’s Atrophy Drug When Combined With Eli Lilly’s Zepbound Shows Around 55% Better Muscle Preservation In Weight Loss Study\nThe Catalent Indiana observations were discussed during Scholar Rock’s second quarter 2025 earnings announcement.\nCatalent Indiana submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. Following that submission, Catalent Indiana has continued to work rapidly to take corrective action and has kept the FDA apprised of that progress.\nUpon Catalent Indiana’s remediation of the FDA observations, Scholar Rock will resubmit the apitegromab BLA.\nOutside of the U.S., the apitegromab marketing authorization application (MAA) is under review by the European Medicines Agency, and a decision is anticipated by mid-2026. The European launch is anticipated in the second half of 2026, with Germany expected to be the first European market to gain patient access.\nIn August, Regeneron Pharmaceuticals Inc. REGN said it expects regulatory approvals to be delayed for its currently pending U.S. Food and Drug Administration (FDA) applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for macular edema following retinal vein occlusion), which have PDUFA dates in August 2025.\nThe anticipated delay concerns observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana.\nPrice Action: SRRK stock is up 1.24% at $32.99 at the last check on Tuesday.\nRead Next:\nPhoto: Shutterstock","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":"policyRegulatory","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/2569288711","isCrawlerRequest":true}