The FDA has issued a complete response letter rejecting Scholar Rock’s apitegromab, a treatment for spinal muscular atrophy (SMA), due to unresolved manufacturing quality problems at a contract facility owned by Novo Nordisk. These issues include pest contamination affecting drug packaging, prompting delays and uncertainty on resubmission timelines. Scholar Rock plans to address the manufacturing compliance concerns before reapplying. The setback emphasizes ongoing regulatory scrutiny around outsourced manufacturing practices in biotech.