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Investing.com -- Scholar Rock (NASDAQ:SRRK) stock fell 17% after the FDA recommended regulatory actions against a third-party manufacturing facility used by the drug developer, potentially delaying its biologics license application (BLA) resubmission.
The FDA has determined that the inspection classification of the Novo Nordisk-owned Catalent Indiana facility is "official action indicated" (OAI), Scholar Rock said in a statement. The company was informed of this development by Novo Nordisk on October 10, following an FDA Form 483 issued to the facility on July 14.
This setback follows Scholar Rock’s receipt of a Complete Response Letter (CRL) for apitegromab on September 23. The company has requested a Type A meeting with the FDA to discuss next steps for resubmitting its BLA and plans to share more information during its third quarter business update call in November.
The manufacturing issues are also affecting Regeneron Pharmaceuticals (NASDAQ:REGN), whose shares fell 2.4% on the news. According to Raymond James, Regeneron will need to submit an additional filler on its application for Eylea HD pre-filled syringe, which will likely delay approval for the 4-week dosing schedule and retinal vein occlusion (RVO) indication until at least the second quarter of 2026.
Truist analyst Srikripa Devarakonda noted that the OAI classification represents a setback for Scholar Rock with the potential to delay resubmission of its BLA.
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