Scholar Rock Holding Corporation SRRK · Stock Open Scholar Rock Holding Corporation in new tab

Shares rallied 10.5% as Scholar Rock advanced toward the U.S. launch of apitegromab, supported by positive regulatory progress and strong commercial readiness, underpinning confidence in near-term approval and market entry.

• The U.S. BLA for apitegromab was accepted in April with a PDUFA action date of September 30; FDA review is progressing with two fill/finish facilities providing regulatory flexibility.
• Significant progress at the second fill/finish facility has resulted in more ready vials than the primary Catalent Indiana site, signaling operational strength.
• Commercial preparations for the U.S. launch are well advanced, with the team positioned to launch apitegromab promptly upon approval.
• European regulatory interactions continue, with the EMA awaiting FDA inspection outcomes; planning underway for an initial launch in Germany and expansion into a 50-country footprint.
• The anti-myostatin clinical pipeline shows active development, including Phase II OPAL and FORGE studies and a Phase I trial of a novel antibody, maintaining momentum beyond apitegromab.