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Scholar Rock Holding Corporation (NASDAQ:SRRK) reported Tuesday that Catalent Indiana, LLC, a manufacturing partner and part of Novo Nordisk, has received a warning letter from the U.S. Food and Drug Administration (FDA). This follows a previously disclosed Form FDA 483 issued to Catalent Indiana on July 14, 2025, and a subsequent inspection classification of “official action indicated” by the FDA.
According to a statement in the SEC filing, Catalent Indiana is continuing to work with the FDA to address the issues cited in the warning letter. Scholar Rock noted that, based on a Type A Meeting held with the FDA on November 12, 2025, and current information from Catalent Indiana, the company still anticipates resubmitting its biologics license application (BLA) for apitegromab and proceeding with a planned U.S. launch for the treatment of spinal muscular atrophy, following regulatory approval, in 2026.
The company reiterated that forward-looking statements are subject to risks and uncertainties, as detailed in its most recent quarterly report.
This update is based on a press release statement included in the company’s Form 8-K filing with the Securities and Exchange Commission. Scholar Rock’s common stock is listed on The Nasdaq Global Select Market under the ticker SRRK.
In other recent news, Scholar Rock reported its third-quarter earnings for 2025, showing a mixed financial outcome. The company posted an earnings per share of -$0.90, which was below the projected -$0.84, marking a 7.14% earnings surprise. Revenue projections of $62,500 were not met, indicating challenges in the company’s revenue stream. Despite these financial results, Wolfe Research initiated coverage on Scholar Rock with an Outperform rating and a price target of $42.00. This decision comes after the FDA issued a Complete Response Letter for Scholar Rock’s lead drug candidate, apitegromab, intended for spinal muscular atrophy. Additionally, BMO Capital raised its price target for Scholar Rock to $50.00 from $45.00, maintaining an Outperform rating. This increase is attributed to Scholar Rock’s efforts to accelerate the technology transfer of commercial capacity to a second facility, creating a contingency plan while awaiting regulatory approval for apitegromab.
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