Disc Medicine Provides Update from FDA Type A Meeting for Bitopertin in Erythropoietic Protoporphyria

▤ Summary

Disc Medicine says it completed an FDA Type A meeting about the Complete Response Letter for bitopertin in erythropoietic protoporphyria. The company and FDA aligned that the ongoing Phase 3 APOLLO study could support a response to the CRL and potentially a traditional approval. Disc expects APOLLO data in Q4 2026 and plans to submit its CRL response by the end of 2026, with an FDA decision expected by mid-2027. Bitopertin remains an investigational therapy and Disc continues to advance it across multiple clinical trials for hematologic diseases.

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