Scholar Rock (SRRK) Q1 2026 earnings summary

Executive summary

• FDA accepted the Biologics License Application (BLA) for apitegromab for SMA, with a PDUFA action date of September 30, 2026; EMA review is ongoing with a CHMP opinion expected mid-2026 and planned European launch in the second half of 2026.

• Commercial launch preparations are advanced in both the U.S. and Europe, with teams and infrastructure in place for immediate rollout upon approval.

• The company is expanding its anti-myostatin pipeline, including phase II and phase I studies for new indications and formulations such as SRK-439.

• Pivotal Phase 3 SAPPHIRE trial for apitegromab in SMA met its primary endpoint, demonstrating significant clinical benefit.

• Net loss for Q1 2026 was $105.5 million, with an accumulated deficit of $1.4 billion as of March 31, 2026.

Financial highlights

• Ended Q1 2026 with $480 million in cash, cash equivalents, and marketable securities, supporting operations into 2027.

• Q1 operating expenses were $102 million, including $80 million in non-cash stock-based compensation; excluding this, expenses were $84 million.

• Research and development expenses rose to $51.8 million, and general and administrative expenses to $50.2 million for Q1 2026.

• Net loss per share was $0.83 for Q1 2026, compared to $0.67 for Q1 2025.

• Raised $98 million from the ATM program and drew down $100 million from a debt facility in Q1.

Outlook and guidance

• Anticipates apitegromab approval and launch in the U.S. by or before September 30, 2026, and in Europe in the second half of 2026, starting with Germany.

• CHMP opinion for European approval expected mid-2026; global opportunity in SMA alone estimated at $2B+.

• Existing cash resources expected to fund operations into 2027; additional capital will be needed for full commercialization and pipeline development.

• Phase 2 studies for apitegromab in infants/toddlers and facioscapulohumeral muscular dystrophy (FSHD) are ongoing or planned for mid-2026; SRK-439 Phase 1 topline data expected in H2 2026.

• Plans to monetize a priority review voucher and may draw an additional $150 million from the debt facility upon FDA approval.