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Stock impact report

Scholar Rock Reports Fourth Quarter and Full Year 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
Apitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA)FDA completed constructive meeting with Catalent Indiana, LLC (part of Novo Nordisk), with discussion of remediation progress and no additional corrective actions requested by FDAScholar Rock plans to resubmit BLA upon successful FDA reinspection of Catalent IndianaApitegromab Marketing Authorisation Application (MAA) review ongoing, with EMA decision anticipated in mid-2026; European launch expected in H2 2026, starting with GermanySecured new debt facility, providing up to $550 million in non-dilutive capital to support commercialization of apitegromab and strategic advancement of key pipeline programsCash, cash equivalents, and marketable securities of $367.6 million as of December 31, 2025Management to host conference call today at 8:00 a.m. ET CAMBRIDGE, Mass.--(BUSINESS WIRE)--S Show less Read more
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