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Scholar Rock Holding Corp (NASDAQ:SRRK) reported Monday that Novo Nordisk informed the company the U.S. Food and Drug Administration (FDA) has classified the Catalent Indiana, LLC facility, owned by Novo Nordisk, as “official action indicated” following a recent inspection. The notification was received on October 10.
The facility’s inspection by the FDA led to the issuance of a Form FDA 483 on July 14, 2025. According to the SEC filing, the “official action indicated” classification means the FDA has identified conditions or practices that warrant regulatory or administrative action.
Scholar Rock disclosed this information in a statement based on a press release and SEC filing. The company’s common stock is listed on the Nasdaq Global Select Market under the symbol SRRK.
No further details regarding the specific findings or regulatory actions were provided in the filing.
In other recent news, Scholar Rock has faced significant challenges concerning its spinal muscular atrophy drug, apitegromab. The company received a Complete Response Letter (CRL) from the FDA, citing procedural issues at a Catalent manufacturing site, which delayed the drug’s approval process. Despite the CRL, no concerns were raised about the drug’s efficacy or safety. Analysts from Piper Sandler and H.C. Wainwright have adjusted their price targets for Scholar Rock, lowering them to $51 and $44, respectively, while maintaining positive ratings. Meanwhile, BofA Securities initiated coverage on Scholar Rock with a Buy rating and a price target of $53, expressing optimism about the potential of apitegromab. The FDA’s regulatory actions also impacted a Novo Nordisk-owned Catalent Indiana facility, which Scholar Rock utilizes, potentially delaying its biologics license application resubmission. These developments underscore the challenges Scholar Rock faces in advancing its treatment for spinal muscular atrophy.
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