Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficiencies

Scholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy.

The decision follows a recent FDA inspection that again identified significant deficiencies at the site, adding to earlier concerns that had already put the location under scrutiny.

By removing the facility from the application, Scholar Rock aims to address regulatory issues and keep the development of its SMA candidate on track, though the move may delay timelines.