SRRK · Scholar Rock Holding Corporation

Scholar Rock Holding Corporation disclosed its first quarter 2026 financial results alongside critical pipeline advancements, particularly for its lead candidate apitegromab in spinal muscular atrophy (SMA). The net loss expanded to $105.5 million, or $0.83 per share, from $74.7 million, or $0.67 per share, in the prior-year quarter, driven by elevated operating expenses. Research and development costs rose to $51.8 million from $48.7 million, reflecting ongoing clinical investments including the Phase 2 OPAL trial in SMA infants and preparations for the Phase 2 FORGE trial in FSHD set for mid-2026 initiation. General and administrative expenses surged to $50.2 million from $28.4 million, primarily due to heightened stock-based compensation of $11.7 million versus $9.4 million last year and commercial launch readiness activities. No revenue was recorded in either period. Balance sheet remains robust with $479.9 million in cash, cash equivalents, and marketable securities as of March 31, 2026, supported by a $100 million debt drawdown and $98 million net proceeds from the at-the-market program, positioning the company through the pivotal PDUFA date. CEO David L. Hallal highlighted the FDA's BLA acceptance as a key milestone, with two fill-finish facilities—Catalent Indiana (reinspected) and a second U.S. site—securing supply paths. The U.S. team is launch-ready immediately upon approval, while European efforts target a second-half 2026 rollout starting in Germany ahead of a mid-2026 CHMP opinion. Subcutaneous apitegromab and SRK-439 programs advance, with Phase 1 data for the latter expected in H2 2026, underscoring pipeline depth amid SMA commercialization focus.