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Stock impact report

Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights

Scholar Rock Holding Corporation (SRRK) 
Last scholar rock holding corporation earnings: 11/12 07:30 am Check Earnings Report
Company Research Source: Business Wire
Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA)Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the site is on-track to be reinspection ready by the end of this yearResubmission of BLA and U.S. launch following approval of apitegromab for children and adults with SMA anticipated in 2026Timelines accelerated with additional apitegromab U.S. fill-finish facility; tech transfer underway with commercial capacity reserved beginning in Q1 2026Dosing underway in Phase 2 OPAL study evaluating apitegromab in infants and toddlers FDA cleared SRK-439 Investigational New Drug (IND) application; dosing in healthy volunteers to commence in Q4 2025Cash, cash equiva Show less Read more
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