Scholar Rock (SRRK) Q4 2025 earnings summary

Executive summary

• Apitegromab is advancing toward anticipated U.S. and EU launches in 2026, with BLA resubmission and EMA review ongoing and commercial teams preparing for launch.

• Regulatory progress includes FDA engagement, remediation at Catalent Indiana, and constructive meetings with no additional corrective actions requested.

• Pipeline progress includes the phase II OPAL trial in infants/toddlers, FSHD phase II FORGE trial initiation planned for mid-2026, and subcutaneous apitegromab development.

• SRK-439, a next-generation myostatin inhibitor, is 10x more potent than apitegromab, with phase I data expected in H2 2026.

• New debt facility of up to $550 million secured to support commercialization and pipeline advancement.

Financial highlights

• Ended 2025 with $368 million in cash and cash equivalents, including $60.4 million from warrant exercises.

• Reported Q4 2025 operating expenses of $91.9 million ($72.5 million excluding stock-based compensation); net loss for Q4 2025 was $91.0 million.

• Full-year 2025 operating expenses were $384.6 million ($309 million excluding stock-based compensation); net loss for 2025 was $377.9 million.

• No revenue recorded for Q4 or full year 2025.

• Research and development expenses for 2025 were $208.4 million; general and administrative expenses were $176.2 million.

Outlook and guidance

• U.S. launch of apitegromab expected in 2026, pending FDA reinspection and approval; EMA decision anticipated mid-2026 with European launch starting in Germany.

• Supplemental BLA for a second fill-finish facility anticipated later in 2026.

• Phase 2 OPAL trial for infants and toddlers with SMA ongoing; Phase 2 FORGE trial for FSHD set to begin mid-2026.

• Topline data from SRK-439 Phase 1 study expected in H2 2026.