Scholar Rock posts first product revenue after ISEMBYLD launch
SRRK•Scholar Rock reported its first product revenue after launching ISEMBYLD in the U.S. and posted a third-quarter net loss of $107.2 million, compared with $102.2 million a year earlier. It also agreed to sell a Priority Review Voucher for $205 million, with cash due upon closing.
1. First product revenue
Scholar Rock said its third quarter marked the U.S. launch of ISEMBYLD, following FDA approval, and its first product revenue. The company reported strong early patient and physician demand, with initial patients infused in October.
2. Quarterly results
Scholar Rock reported a third-quarter net loss of $107.24 million, compared with $102.2 million a year earlier. Income from operations was negative $106.06 million and operating expenses were $106.63 million.
3. Regulatory outlook
The company agreed to sell a Priority Review Voucher for $205 million, with cash to be received upon closing. It expects a European CHMP opinion on apitegromab in the first half of 2027 and anticipates a Japanese priority review with an approximately nine-month review cycle; it is also engaging with regulators on a development path for subcutaneous apitegromab.
