Scholar Rock (SRRK) Soars 29% as Drug Candidate Progresses

Core Insights - Scholar Rock Holding Corp. (NASDAQ:SRRK) experienced a significant share price increase of 29.2% week-on-week, driven by positive developments regarding its drug candidate for spinal muscular atrophy (SMA) [1][4] Company Developments - The company recently met with the Food and Drug Administration (FDA) and its manufacturing contractor, Catalent Indiana, to discuss the biologics license application (BLA) for apitegromab, following a previous rejection due to inspection issues [2][3] - Catalent reported progress in its remediation plan, with plans for the facility to be ready for reinspection by the end of the year [3] - Scholar Rock aims to resubmit the BLA application, targeting an official launch of apitegromab next year and seeking European Medicines Agency (EMA) approval by mid-2026 [4] Financial Performance - In the third quarter, Scholar Rock widened its net loss by 58% to $102 million, compared to $64.5 million in the same period last year, primarily due to a 60% increase in operating loss to $103.5 million from $64.78 million year-on-year [5]