News & Events
Disc Medicine Announces Successful Type C Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP) and Shares Plans for NDA Submission
Pursuing accelerated approval for bitopertin in EPP with protoporphyrin IX (PPIX) reduction as the surrogate endpoint Planning to submit NDA under accelerated approval pathway in H2 2025 based on existing clinical data, including results from BEACON and AURORA Phase 2 trials Achieved regulatory
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Disc Medicine Announces Positive Pre-NDA Meeting and Confirms Plans to Submit NDA for Bitopertin in Erythropoietic Protoporphyria (EPP) in October 2025
WATERTOWN, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and...
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Disc Medicine Appoints Nadim Ahmed to its Board of Directors
WATERTOWN, Mass., July 14, 2025 (GLOBE NEWSWIRE) — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and...
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Disc Medicine Presents Positive Clinical Data Updates Across Portfolio at the European Hematology Association (EHA) 2025 Annual Congress
Positive updates across all programs, including longer term efficacy and safety data from the HELIOS open-label extension trial of bitopertin in erythropoietic...
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