Core Insights - Disc Medicine, Inc. is focused on developing novel treatments for serious hematologic diseases and has made significant progress in its pipeline and strategic priorities for 2026 [1][2] Summary of Key Achievements During 2025 - Bitopertin received the Commissioner's National Priority Review Voucher (CNPV) and the NDA was submitted under the accelerated approval pathway, which is currently under FDA review [5][6] - Positive initial Phase 2 data from the RALLY-MF study of DISC-0974 in anemia of myelofibrosis was reported, showing robust hematologic activity [6] - The company strengthened its balance sheet through two equity offerings, resulting in cash, cash equivalents, and marketable securities totaling $791 million as of December 31, 2025, providing financial runway into 2029 [6] Key Business Objectives and Milestones for 2026 - The company plans to launch bitopertin for EPP in the US, pending FDA approval, and continue enrollment in the global APOLLO confirmatory study with topline data expected by early 2027 [5][6] - Multiple Phase 2 updates for DISC-0974 and DISC-3405 are anticipated, including important regulatory interactions and expansion into new indications [2][5] - An End of Phase 2 meeting with the FDA regarding DISC-0974 in MF anemia is scheduled for H2 2026, along with updated data from ongoing Phase 2 studies for DISC-0974 and DISC-3405 expected in H2 2026 [5][11]
Disc Medicine Highlights Recent Achievements and Key Business Objectives and Milestones for 2026