Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection
1. FDA issued a Complete Response Letter for Scholar Rock's apitegromab application. 2. CRL related to routine inspection of Catalent Indiana, not specific to drug efficacy. 3. Catalent Indiana is engaging in corrective actions and will resubmit to the FDA. 4. European regulations for apitegromab expected decision by mid-2026. 5. Regulatory delays reported for Regeneron’s EYLEA due to similar inspection concerns.