Core Insights - Disc Medicine, Inc. reported significant progress in 2024, particularly with the potential accelerated approval for bitopertin based on Phase 2 results in erythropoietic protoporphyria (EPP) patients [2][5] - The company plans to initiate the APOLLO trial in mid-2025 and submit a New Drug Application (NDA) in the second half of 2025 [2][5] - Positive clinical data was reported across the company's portfolio, including for DISC-0974 in anemias of myelofibrosis (MF) and non-dialysis-dependent chronic kidney disease (NDD-CKD) [2][5] Recent Highlights and Anticipated Milestones - Bitopertin is positioned for NDA submission in EPP through an accelerated approval pathway, with the APOLLO trial set to begin by mid-2025 [5][6] - Positive updates from Phase 1b trials of DISC-0974 in MF and NDD-CKD were presented, with initial data from ongoing studies expected in H2 2025 [5][6] - The company also plans to initiate a Phase 2 study for DISC-3405 in polycythemia vera (PV) in H1 2025 [5][6] Financial Overview - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling 360.4 million in 2023 [10][19] - Research and development expenses rose to 69.3 million in 2023, reflecting advancements in clinical studies and increased headcount [10][17] - The net loss for 2024 was 76.4 million in 2023, primarily due to higher operating costs [10][18]
Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update