Disc Medicine posts corporate deck highlighting bitopertin in EPP pipeline progress

Disc Medicine, Inc.

Disc Medicine, Inc.

IRON

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  • Disc Medicine outlined plans to file a complete response to the FDA by end-2026 for bitopertin in EPP.
  • FDA Type A meeting alignment that the Phase 3 APOLLO trial could support the CRL response and a traditional approval if positive.
  • APOLLO enrollment completed in March 2026 with 183 patients; topline data expected in Q4 2026.
  • HELIOS open-label extension showed sustained PPIX reductions beyond 1 year; median exposure 25.3 months with 5% Grade 3 TEAEs.
  • RALLY-MF Phase 2 update for selcodebart showed 72% overall response and 56% major response; positioned for about 22,000 anemic MF patients.


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