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Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP

Disc Medicine (IRON)Disc MedicineFDA / regulatory

FDA acknowledged that AURORA and BEACON provided sufficient evidence that bitopertin significantly lowers PPIX and that there is a strong mechanistic and biological plausibility supporting the use of the PPIX biomarker in protoporphyria FDA indicated a need to see the results of the ongoing Phase 3

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Disc Medicine

Hematology Drug Development Disc Medicine develops therapies for serious hematologic diseases by targeting pathways involved in heme biosynthesis and iron regulation. Its portfolio addresses both rare red-blood-cell disorders and anemia associated with chronic disease. Bitopertin in EPP Bitopertin is being evaluated in the Phase 3 APOLLO...

Recent company news

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Disc Medicine Reports Second Quarter 2026 Financial Results and Provides Business Update

IRONDisc Medicine2026-06-12 12:30 EST

Disc Medicine Presents Positive Clinical Updates at the 2026 European Hematology Association (EHA) Annual Meeting

IRONDisc Medicine2026-06-09 12:30 EST

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

IRONDisc Medicine2026-06-02 12:00 EST

Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

IRONDisc Medicine2026-06-01 12:30 EST

Disc Medicine Launches Expanded Access Program for Bitopertin for EPP Patients

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