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Investing.com - BMO Capital has lowered its price target on Scholar Rock (NASDAQ:SRRK) to $45.00 from $57.00 while maintaining an Outperform rating on the stock. Despite the target reduction, SRRK has demonstrated remarkable strength with a 319% return over the past year. According to InvestingPro data, the stock currently trades at $34.62, with analyst targets ranging from $46 to $57.
The price target reduction comes as BMO Capital analyst Etzer Darout cited ongoing problems at Novo’s Catalent (NYSE:CTLT) facilities that could potentially impact the PDUFA date for apitegromab, Scholar Rock’s investigational drug.
Apitegromab is produced within Novo’s Catalent facilities, which were previously flagged for FDA observations during a pre-approval site visit, creating uncertainty around the drug’s regulatory timeline.
The analyst noted that last week, Regeneron (NASDAQ:REGN) received a Complete Response Letter (CRL) for odronextamab approval and experienced a delayed response for the label extension of Eylea HD Q4W dosing, suggesting broader regulatory challenges related to Novo Catalent facilities.
While Scholar Rock’s management has expressed confidence in apitegromab’s approval, BMO Capital indicates that delays are possible "given late CMC issue identification and proximity to PDUFA," leading to the reduced price target.
In other recent news, Scholar Rock reported its second-quarter 2025 earnings, which showed an EPS of -0.98. This result was below the expected EPS of -0.66, representing a 48.48% negative surprise. The earnings miss has raised concerns among investors regarding the company’s financial performance. Additionally, Raymond (NSE:RYMD) James has maintained its Strong Buy rating for Scholar Rock, with a price target of $53.00. This decision comes as the company approaches a significant milestone with the upcoming PDUFA date for its drug candidate, apitegromab, on September 22nd. These developments highlight key areas of interest for investors monitoring Scholar Rock’s progress.
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