Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violations

Scholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the plant as Official Action Indicated, signaling serious compliance concerns.

Novo acquired the Indiana site and two other Catalent locations in 2024 for $11 billion to expand capacity for its GLP‑1 drugs Ozempic and Wegovy. The acquisition also brought in contract manufacturing customers, including Scholar Rock.

Although Scholar Rock praised the plant’s “significant progress” in March, the April FDA inspection resulted in the OAI rating, prompting the company to drop the facility from its approval application for the therapy apitegromab.