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The shift to an alternate fill-finish facility reduces regulatory risk and strengthens the path to FDA approval by the PDUFA date; PMDA/JNDA progress adds optional near-term catalysts and lowers regulatory uncertainty, potentially lifting SRRK's valuation on a clear commercial launch trajectory.
What happened, with direct paths to the underlying reporting
Scholar Rock disclosed regulatory progress for apitegromab in SMA, removing Catalent Indiana as the fill-finish site and relying on an alternate facility. The FDA is progressing toward a decision by the Sep 30, 2026 PDUFA date, and PMDA has allowed a JNDA submission by year-end 2026 with no extra Japanese trials. If approvals occur on schedule, US launch could start in Q3 2026 with a global rollout strategy.
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