The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s apitegromab Biologics License Application (BLA) for spinal muscular atrophy (SMA).

The CRL is related to observations identified during a routine general site inspection of Catalent Indiana LLC, a third-party fill-finish facility which Novo Nordisk A/S acquired in December 2024.

The observations are not specific to apitegromab.

The CRL did not cite any other approvability concerns, including apitegromab’s efficacy and safety data or the third-party drug substance manufacturer.

Also Read: Scholar Rock’s Atrophy Drug When Combined With Eli Lilly’s Zepbound Shows Around 55% Better Muscle Preservation In Weight Loss Study

The Catalent Indiana observations were discussed during Scholar Rock’s second quarter 2025 earnings announcement.

Catalent Indiana submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. Following that submission, Catalent Indiana has continued to work rapidly to take corrective action and has kept the FDA apprised of that progress.

Upon Catalent Indiana’s remediation of the FDA observations, Scholar Rock ( SRRK ) will resubmit the apitegromab BLA.

Outside of the U.S., the apitegromab marketing authorization application (MAA) is under review by the European Medicines Agency, and a decision is anticipated by mid-2026. The European launch is anticipated in the second half of 2026, with Germany expected to be the first European market to gain patient access.

In August, Regeneron Pharmaceuticals Inc. ( REGN ) said it expects regulatory approvals to be delayed for its currently pending U.S. Food and Drug Administration (FDA) applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for macular edema following retinal vein occlusion), which have PDUFA dates in August 2025.

The anticipated delay concerns observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana.

Price Action: SRRK stock is up 1.24% at $32.99 at the last check on Tuesday.

Read Next:

Tesla Records 17.3K Insured Registrations In China During 3rd Week Of September, Sales Grow Over 33%