As of Oct 26, 2026: Scholar Rock Holding (SRRK) announced the FDA's approval of apitegromab on Sep 14, 2026; its PDUFA date was Sep 30, 2026. Its Quality Score is -2. Scores as of 8:31 PM ET, 15 minutes behind.

SRRK FDA decision on Apitegromab

Scholar Rock Holding · PDUFA date

OutcomeApprovedannounced Sep 14 Quality Score-2Poor

Cash runway6quarters of cash

The FDA's decision

Approved. Scholar Rock Holding announced the FDA's approval of apitegromab on Sep 14, 2026.

“by FDA continues to advance with two fill-finish facilities, representing two independent paths to an FDA approval decision by September 30, 2026 Prescription Drug User Fee Act (PDUFA) date”

PDUFA date, Sep 30, 2026. As Scholar Rock Holding stated in its 8-K of Aug 6, 2026 (the filing).

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How SRRK's stock moved on its past FDA days, for Pro members. Pro members also see the members' FDA calendar with filters and optional alerts.

More on SRRK and the FDA calendar

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The FDA calendar.