Scholar Rock Holding Corporation is a global biopharmaceutical company focused on rare, severe, and debilitating neuromuscular diseases, particularly Spinal Muscular Atrophy (SMA) and Facioscapulohumeral Muscular Dystrophy (FSHD). The company's lead product candidate, apitegromab, is an investigational monoclonal antibody designed to inhibit myostatin activation to increase muscle mass and strength. A Biologics License Application (BLA) for apitegromab in SMA was submitted to the FDA in January 2025 and granted Priority Review in March 2025; a Marketing Authorisation Application (MAA) was accepted by the EMA in March 2025. On September 22, 2025, the FDA issued a Complete Response Letter (CRL) for apitegromab's BLA, citing cGMP deficiencies at a third-party fill-finish facility, which has delayed potential U.S. commercialization. The CRL observations were site-related and not specific to apitegromab's efficacy or safety data, or the third-party drug substance manufacturer. A constructive Type A meeting with the FDA was completed in November 2025, and the third-party facility received a warning letter in November 2025, with ongoing efforts to resolve the issues. Positive top-line data from the Phase 3 SAPPHIRE study for apitegromab in children and adults with SMA were reported in October 2024, demonstrating a statistically significant and clinically meaningful improvement in motor function (HFMSE mean difference of 1.8 points for combined 10/20 mg/kg doses vs. placebo, p=0.0192). The company initiated the Phase 2 OPAL study for apitegromab in infants and toddlers with SMA and plans to initiate a Phase 2 FORGE study for FSHD in mid-2026. A Phase 1 study of subcutaneous apitegromab was completed, showing favorable bioavailability and a comparable pharmacodynamic profile. A Phase 1 study of SRK-439, a novel subcutaneously administered anti-myostatin antibody, is underway with topline data anticipated in the second half of 2026. The Phase 2 EMBRAZE study demonstrated proof-of-concept for apitegromab to preserve lean mass during tirzepatide-induced weight loss. The company reported a net loss of $377.9 million for the year ended December 31, 2025, an increase from $246.3 million in 2024, with an accumulated deficit of $1.3 billion. Research and development expenses increased by 12.9% to $208.4 million in 2025, while general and administrative expenses surged by 161.0% to $176.2 million, driven by commercialization build-out and leadership changes. Cash, cash equivalents, and marketable securities decreased to $367.6 million as of December 31, 2025, from $437.3 million in 2024. In February 2026, the company secured a new Financing Agreement with Blue Owl Capital Corporation for up to $350.0 million, using an initial $100.0 million to repay previous debt of $103.7 million to Oxford Finance LLC. Existing liquidity is expected to fund operating expenses and capital expenditure requirements into 2027, but additional capital will be required to complete clinical development and commercialization for all current programs. The company no longer qualifies as a smaller reporting company as of January 1, 2026, which will lead to increased compliance costs and demands on management.