Biotech Slumps On Surprise FDA Rejection

Shares of Scholar Rock (SRRK) tumbled Tuesday after the Food and Drug Administration rejected the company's spinal muscular atrophy drug, citing concerns at the Catalent fill-finish facility in Indiana. Fill finish is the final manufacturing step for some drugs, involving filling drug substances into final containers, like vials and syringes. FDA inspectors found some problems during a regular inspection of the Catalent facility, which Novo Nordisk (NVO) owns, in December 2024. Wedbush analyst David Nierengarten said Catalent responded to the FDA in August. The rejection likely sets Scholar Rock's apitegromab...