Approval DelaysSRRK's third-party fill-finish manufacturer received an Official Action Indicated (OAI) classification by FDA, suggesting a re-inspection will likely be required before the drug can receive approval.
Market VolatilityScholar Rock's shares are expected to remain volatile and very sensitive to any additional headlines or disclosures in the near term.
Regulatory ChallengesThe Catalent Indiana facility, acquired by Novo Nordisk, received an Official Action Indicated (OAI) classification, which is seen as a net negative for near-term approval prospects for Scholar Rock's apitegromab.