BUZZ-Scholar Rock falls on FDA review; analysts flag optimistic expectations

Reuters

01/12

BUZZ-<a href="https://laohu8.com/S/SRRK">Scholar Rock</a> falls on FDA review; analysts flag optimistic expectations

** Shares of drug developer Scholar Rock SRRK.O down 2.5% at $41.12

** SRRK says U.S. FDA has scheduled meeting with third-party manufacturing facility, Catalent Indiana, part of Novo Nordisk NOVOb.CO, in early 2026 to discuss progress of remediation efforts

** Expects resubmission of marketing application of apitegromab for muscle weakness and U.S. launch following FDA's potential approval in 2026

** In September, agency declined to approve apitegromab citing issues at the facility

** "Catalent site could take time to be resolved" - Truist analyst Srikripa Devarakonda

** Adds: "This is in-line with our model baseline assumptions of H1 2026 or mid-2026 submission of BLA and 2027 launch"

** SRRK expects to submit a supplemental application for apitegromab to treat facioscapulohumeral muscular dystrophy with second site later in 2026

** Stock fell 7.3% in 2025

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))

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analysts flag optimistic expectations</title></head><body><p>** Shares of drug developer Scholar Rock <span>SRRK.O</span> down 2.5% at $41.12</p><p>** SRRK says U.S. FDA has scheduled meeting with third-party manufacturing facility, <a href=\"https://laohu8.com/S/CTLT\">Catalent</a> Indiana, part of <a href=\"https://laohu8.com/S/NVO\">Novo Nordisk</a> <span>NOVOb.CO</span>, in early 2026 to discuss progress of remediation efforts</p><p>** Expects resubmission of marketing application of apitegromab for muscle weakness and U.S. launch following FDA's potential approval in 2026  </p><p>** In September, agency <span>declined to approve</span> apitegromab citing issues at the facility</p><p>** \"Catalent site could take time to be resolved\" - Truist analyst Srikripa Devarakonda</p><p>** Adds: \"This is in-line with our model baseline assumptions of H1 2026 or mid-2026 submission of BLA and 2027 launch\"</p><p>** SRRK expects to submit a supplemental application for apitegromab to treat facioscapulohumeral muscular dystrophy with second site later in 2026</p><p>** Stock fell 7.3% in 2025</p><p>(Reporting by Siddhi Mahatole)</p><p>((siddhi.mahatole@thomsonreuters.com))</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SRRK","symbol_name":"Scholar Rock Holding Corp","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260112:nL4N3YD18H:1","article_id":"2602541650","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602541650","pubTimestamp":1768231720,"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":"BUZZ-Scholar Rock falls on FDA review; 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