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Disc Medicine Provides Update on Hematology Portfolio and Outlines Near-Term Business Objectives and Anticipated Milestones
Globenewswireยท 2025-10-20 10:30
Core Insights - Disc Medicine, Inc. is focused on advancing its pipeline for serious hematologic diseases, with key developments in Erythropoietic Protoporphyria (EPP) and myeloproliferative neoplasms, including myelofibrosis (MF) and polycythemia vera (PV) [1][2] Pipeline and Development Progress - The company is accelerating the development of bitopertin for EPP, having submitted a New Drug Application (NDA) for accelerated approval and received the FDA's Commissioner's National Priority Voucher (CNPV) to expedite the review process to 1-2 months [5][6] - Initial data from the Phase 2 RALLY-MF trial of DISC-0974 in anemia of MF is expected by the end of 2025, with topline data anticipated in 2026 [3][6] - DISC-3405 is being developed for PV, with data expected in 2026, and plans to initiate a Phase 2 trial for DISC-0974 in anemia of inflammatory bowel disease in 2026 [3][11] Financial Position - As of the end of Q3 2025, the company reported a strong financial position with approximately $616 million in cash, cash equivalents, and marketable securities, supporting its ongoing development efforts [5][6] Strategic Objectives - The company aims to drive enrollment in the ongoing APOLLO confirmatory trial of bitopertin in EPP to support potential approval in the US and other territories [6] - Plans include advancing DISC-0974 into late-stage clinical development for anemia of MF and exploring the role of hepcidin in additional indications [6][11]