Scholar Rock reported a Q4 2025 net loss of USD 91.0 million, with net loss per share of USD 0.88, and no revenue. R&D expense in Q4 was USD 46.9 million and G&A expense was USD 45.0 million. Cash, cash equivalents and marketable securities totaled USD 367.6 million as of December 31, 2025. For FY 2025, Scholar Rock posted a net loss of USD 377.9 million, with net loss per share of USD 3.29, and no revenue. Full-year R&D expense was USD 208.4 million and G&A expense was USD 176.2 million. On the business front, Scholar Rock said its top priority is advancing apitegromab in spinal muscular atrophy, with BLA resubmission and a potential U.S. launch, if approved, expected in 2026 following a successful FDA reinspection of the Catalent Indiana facility. The company said EMA review of the apitegromab MAA is ongoing, with a decision expected in mid-2026, and it is planning for a European launch in the second half of 2026 starting with Germany. Scholar Rock also said it is progressing technology transfer to a second U.S.-based fill-finish facility and expects to submit a supplemental BLA for that site later in 2026. Pipeline updates included the ongoing Phase 2 OPAL study of apitegromab in infants and toddlers with SMA, continued development of a subcutaneous formulation (Phase 1 completed in healthy volunteers), planned initiation of the Phase 2 FORGE trial in FSHD in mid-2026, and an ongoing Phase 1 healthy volunteer study of SRK-439 with topline data expected in the second half of 2026. Scholar Rock also announced a new debt facility for up to USD 550 million from funds managed by Blue Owl Capital, maturing in February 2032, including USD 100 million available at closing (used to retire prior debt) and an additional USD 100 million expected to be drawn in Q1 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Scholar Rock Holding Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20260303854888) on March 03, 2026, and is solely responsible for the information contained therein.