Business Wire·May 7, 2026, 7:00 AM ET

Scholar Rock Reports First Quarter 2026 Financial Results and Recent Business Highlights

FDA accepted the apitegromab BLA for spinal muscular atrophy with a PDUFA action date of September 30, 2026.
The approved BLA includes two U.S. fill-finish facilities: Catalent Indiana LLC and a second U.S.-based facility.
FDA completed a reinspection of Catalent Indiana, with facility classification expected within 90 days.
Commercial supply from the second fill-finish facility is scheduled for early Q3 2026.
Scholar Rock's U.S. commercial team is prepared to launch apitegromab immediately upon FDA approval.
EMA CHMP opinion for the apitegromab MAA is anticipated near mid-2026, with a European launch planned for the second half of 2026.
Enrollment is ongoing in the Phase 2 OPAL trial for infants and toddlers with SMA.
Development continues on a subcutaneous apitegromab formulation, with a completed Phase 1 study in healthy volunteers.
The Phase 2 FORGE trial for facioscapulohumeral muscular dystrophy (FSHD) is on track to initiate in mid-2026.
SRK-439 Phase 1 study in healthy volunteers is underway, with topline data expected in the second half of 2026.
Scholar Rock reported a net loss of $105.5 million for Q1 2026, compared to $74.7 million in Q1 2025.
The company recorded zero revenue for the quarters ended March 31, 2026, 2025.
Cash, cash equivalents, and marketable securities totaled $479.9 million as of March 31, 2026, including $100 million in debt proceeds and $98 million in ATM proceeds.
Management will host a conference call on May 7, 2026, at 8:00 a.m. ET to discuss results.