Business Wire·Nov 14, 2025, 7:00 AM ET

Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights

SRRK

Scholar Rock held a constructive in-person Type A meeting with the FDA on November 12, 2025, regarding the apitegromab BLA for spinal muscular atrophy (SMA).
Catalent Indiana, LLC confirmed it is on track to be reinspection ready by the end of 2025.
Resubmission of the BLA & U.S. launch of apitegromab are anticipated in 2026 following FDA approval.
Timelines for apitegromab have been accelerated with a second U.S. fill-finish facility where tech transfer is underway & commercial capacity is reserved for Q1 2026.
The EMA expects to issue a decision on the apitegromab Marketing Authorisation Application by mid-2026.
Dosing has commenced in the Phase 2 OPAL study evaluating apitegromab in infants & toddlers under 2 years of age with SMA.
The FDA cleared the SRK-439 Investigational New Drug application, with dosing in healthy volunteers expected in Q4 2025.
Clinical development activities for a second neuromuscular indication are scheduled to initiate by year-end 2025.
Scholar Rock reported a net loss of $102.2 million for the quarter ended September 30, 2025, compared to $64.5 million in the prior year period.
Research & development expenses were $50.5 million, while general & administrative expenses increased to $53.1 million primarily due to launch readiness investments.
The company held $369.6 million in cash, cash equivalents, & marketable securities as of September 30, 2025, with funds expected to sustain operations into 2027.
No revenue was generated for the quarter ended September 30, 2025.
Scholar Rock hosted a conference call on November 14, 2025, at 8:00 a.m. ET to review financial results & business updates.