Business Wire·Aug 6, 2026, 7:00 AM ET

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

SRRK

FDA review of Scholar Rock's apitegromab Biologics License Application (BLA) for spinal muscular atrophy is advancing with two independent fill-finish facilities, supporting a potential approval decision by the September 30, 2026 PDUFA date.
The data package for the second fill-finish facility has been submitted to the FDA, with ample commercial supply available upon approval.
FDA inspection classification for the Catalent Indiana LLC facility remains pending following a general site inspection in April 2026.
Scholar Rock's U.S. commercial team is prepared to launch apitegromab immediately upon FDA approval.
The company is engaging with the European Medicines Agency (EMA) regarding the Marketing Authorisation Application (MAA), awaiting FDA inspection results before potentially adding the second fill-finish facility to the MAA.
The Phase 2 FORGE study evaluating apitegromab in patients with facioscapulohumeral muscular dystrophy (FSHD) has been initiated with approximately 60 patients.
Enrollment in the Phase 2 OPAL trial for apitegromab in infants and toddlers with SMA is ongoing.
Development of a high-concentration subcutaneous formulation of apitegromab is progressing, with plans to align with regulators post-approval.
SRK-439, a novel subcutaneous myostatin inhibitor, has a Phase 1 study in healthy volunteers ongoing with topline data anticipated in late 2026.
Scholar Rock reported a net loss of $109.9 million for the quarter ended June 30, 2026, with no revenue recorded.
Cash, cash equivalents, and marketable securities totaled $492.1 million as of June 30, 2026, including $62.8 million in net proceeds from the at-the-market (ATM) program.
A conference call to review second quarter 2026 financial results and business updates is scheduled for August 6, 2026, at 8:00 a.m. ET.