Scholar Rock is removing Catalent's Indiana fill-finish facility from its FDA application for apitegromab after being told the agency found significant compliance issues during an April inspection, while keeping the spinal muscular atrophy drug on track for a Sept. 30 decision. The company resubmitted the application in March with two fill-finish sites after the U.S. Food and Drug Administration last year declined to approve apitegromab over problems at the same Catalent facility, which has since been acquired by Novo Nordisk. Review will now proceed solely through a second U.S.-based fill-finish facility, where Scholar Rock said robust supply is available. Citi analysts said approval by Sept. 30 would improve confidence in eventual approvals elsewhere.