Scholar Rock Reports Third Quarter 2026 Financial Results and Recent Business Highlights
Business Wire•10/11/2026•07:00 ET
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Key Highlights
- ➤ISEMBYLD FDA-approved September 11, 2026; U.S. launch underway
- ➤ISEMBYLD generated $0.6 million in Q3 U.S. product revenue
- ➤Scholar Rock agreed to sell its Priority Review Voucher for $205 million
- ➤Cash, equivalents, and marketable securities totaled $413.6 million at September 30, 2026
- ➤European apitegromab MAA validated; CHMP opinion expected in H1 2027
Expert Statements
David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock
“The third quarter was a defining period for Scholar Rock, marked by the FDA approval and U.S. launch of ISEMBYLD, the world’s first and only muscle-targeted therapy for children and adults living with SMA. We are very encouraged by the early ISEMBYLD launch dynamics in the U.S., where the breadth of early demand across SMA treatment centers, physicians, and patients reinforces the significant unmet need in the SMA community. With the U.S. launch underway, our regulatory applications advancing in Europe and Japan, important progress across our world-leading anti-myostatin pipeline, and our strengthened financial position, we are building a foundation to redefine the treatment of neuromuscular disease globally and drive sustainable growth for years to come.”
Scholar Rock Reports Third Quarter 2026 Financial Results and Recent Business Highlights
* U.S. launch of ISEMBYLD™ (apitegromab-mstn), the first and only muscle-targeted therapy for children and adults living with spinal muscular atrophy (SMA), underway following September 11, 2026 FDA approval
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