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Disc Medicine (IRON) investor relations material
Disc Medicine Stifel 2025 Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Portfolio overview and pipeline progress
Focused on treatments for serious hematologic diseases, targeting heme synthesis and iron homeostasis pathways.
Lead program, Bidapertin, is an oral GLIT1 inhibitor for erythropoietic protoporphyria (EPP), with NDA submitted in late September.
Received FDA Commissioner's National Priority Voucher, accelerating potential commercialization to late 2023 or early 2024.
Iron regulation programs include Disco 974 (hemojuvelin antibody, phase 2 for myelofibrosis anemia) and Disc 3405 (Tempor S6 antibody, phase 2 for polycythemia vera).
First data readout for Disc 3405 in polycythemia vera expected next year.
Regulatory and commercialization timeline
CNPV award reduces FDA review time for Bidapertin from 10–12 months to 1–2 months post-NDA acceptance.
NDA acceptance expected around late November, with potential approval by December or January.
Anticipates label to include adolescents (12+) and adults, supported by efficacy and safety data.
Commercial infrastructure is being built in stages, with initial focus on market access and existing MSL teams; full Salesforce deployment expected mid-year.
Launch strategy and patient identification
EPP has a specific ICD-10 code, enabling targeted account mapping and claims analysis.
Early launch will leverage clinical trial patients, advocacy groups, and centers of excellence for steady growth.
No expected negative impact on ongoing global phase 3 Apollo trial enrollment from commercial availability.
Next Disc Medicine earnings date
Next Disc Medicine earnings date
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