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; commercial launch preparations are advanced in the U.S. and Europe, with teams and infrastructure in place for rapid rollout upon approval.

• EMA review of apitegromab is ongoing, with a CHMP opinion expected mid-2026 and a planned European launch in the second half of 2026, starting with Germany.

• The company is advancing its anti-myostatin pipeline, including apitegromab and SRK-439, with Phase 2 and Phase 1 studies for additional indications and formulations.

• 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 $479.9 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 increased to $50.2 million in 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 2026.

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.

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

• Expects to serve up to 35,000 SMA patients globally who have received at least one SMN-targeted therapy; global SMA opportunity estimated at over $2 billion.

• Phase 2 FORGE trial for FSHD expected to initiate in mid-2026; SRK-439 Phase 1 topline data anticipated in the second half of 2026.

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