Earnings Releases·Nov 10, 2026, 7:10 AM ET

Scholar Rock — Third Quarter 2026 Earnings Summary

Reported a net loss of $107.2 million for Q3 2026, an increase from $102.2 million in the prior year period, while net loss per share improved to $0.81 from $0.90; generated $0.6 million in net product revenue from U.S. ISEMBYLD sales.
Secured a definitive agreement to sell its Priority Review Voucher for $205 million in November, with cash receipt pending closing conditions, bringing total cash, cash equivalents, and marketable securities to $413.6 million as of September 30, 2026.
ISEMBYLD launched in the U.S. following FDA approval on September 11, 2026, with initial patient infusions occurring in October 2026 and early launch dynamics showing strong demand across treatment centers.
Provided regulatory outlooks including an expected CHMP opinion on apitegromab in Europe in H1 2027, anticipated completion of Japan's priority review in approximately nine months, and top-line data from the Phase 1 SRK-439 study expected by end of 2026.
Ongoing clinical programs include the Phase 2 OPAL trial for infants and toddlers with SMA, the Phase 2 FORGE trial for FSHD, and the Phase 1 SRK-439 study in healthy volunteers, alongside plans to expand ISEMBYLD access to up to 50 countries.