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Optimistic Outlook for Scholar Rock Holdings Amid Regulatory Challenges

Optimistic Outlook for Scholar Rock Holdings Amid Regulatory Challenges

J.P. Morgan analyst Jessica Fye has maintained their bullish stance on SRRK stock, giving a Buy rating yesterday.

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Jessica Fye’s rating is based on several key considerations surrounding Scholar Rock Holding’s recent developments. Despite the Complete Response Letter (CRL) received for apitegromab’s Biologics License Application (BLA), the issues were linked solely to a third-party facility inspection rather than the drug’s safety or efficacy, which remains a positive indicator for the company’s prospects. Scholar Rock’s management has shown a proactive approach in addressing the CRL, emphasizing constructive discussions with the FDA and their commitment to resolving the issues swiftly.
Furthermore, the company’s expectations for a decision on their Marketing Authorization Application (MAA) in the EU by mid-2026, along with a potential launch in the latter half of 2026, reflects a promising outlook. While the CRL has introduced some uncertainty and potential delays, the overall sentiment remains optimistic due to the manageable nature of the concerns and the company’s strategic efforts to address them.

In another report released yesterday, Barclays also maintained a Buy rating on the stock with a $44.00 price target.

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