News & Events
Disc Medicine Announces Successful End of Phase 2 Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria (EPP), Including Potential for Accelerated Approval
Alignment with the FDA across all proposed study parameters, providing a clear development path to registration Agreement on proposed primary endpoint of average monthly time in sunlight during the last month following a 6-month treatment period Potential for accelerated approval based on existing
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Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Targeting NDA submission for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 through accelerated approval pathway; on track to initiate APOLLO post-marketing...
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Disc Medicine Announces Pricing of $225.5 Million Upsized Public Offering of Common Stock and Pre-Funded Warrants
WATERTOWN, Mass., Jan. 22, 2025 (GLOBE NEWSWIRE) — Disc Medicine, Inc. (NASDAQ: IRON) (Disc), a clinical-stage biopharmaceutical company focused on the discovery,...
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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...
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