Scholar Rock notified that FDA classifies Catalent Indiana facility as 'official action indicated'

Scholar Rock Holding Corp

Novo Nordisk informed Scholar Rock on Oct 10 that FDA classified Catalent Indiana (owned by Novo Nordisk) as 'official action indicated' (OAI).
OAI classification follows a Form FDA 483 issued July 14, 2025, citing significant objectionable conditions at the facility.
Filing does not specify the impact on Scholar Rock's manufacturing, supply chain, or regulatory timelines.
Scholar Rock provided no assessment of potential delays or financial effect in the filing.

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