FDA Approves Scholar Rock's ISEMBYLD
Scholar Rock Holding (SRRK) won approval for ISEMBYLD under BLA 761463, with the agency's status date of September 11, 2026.
Scholar Rock Holding (SRRK) won FDA approval for ISEMBYLD. The agency's record lists Scholar Rock Inc. as sponsor of record, with application BLA761463, submission 1 (ORIG), and a status date of September 11, 2026.
On August 6, 2026, Scholar Rock filed a prospectus supplement under its shelf registration statement on Form S-3ASR, File No. 333-282530, relating to an at-the-market program with Jefferies LLC as sales agent. The supplement covered additional shares of common stock having an aggregate offering price of up to $200,000,000 and replaced a prior prospectus supplement dated November 14, 2025, terminating that earlier offering.
As of that date, Scholar Rock had raised approximately $257.7 million in net proceeds from shares of common stock under the ATM Program. Goodwin Procter LLP issued a legal opinion relating to the shares.
On the same date, the company issued a press release announcing financial and operating results for the quarter ended June 30, 2026, furnished as Exhibit 99.1 to an Item 2.02 Form 8-K.