Disc Medicine Advances Bitopertin NDA for Erythropoietic Protoporphyria as Pipeline Progress Continues
• Disc Medicine has initiated the APOLLO confirmatory trial for bitopertin in erythropoietic protoporphyria (EPP) and remains on track to submit an NDA under accelerated approval pathway in the second half of 2025.
• The company is advancing its hematologic disease pipeline with DISC-0974 studies in myelofibrosis and chronic kidney disease anemia, with data readouts expected in H2 2025.
• Following a successful $259 million public offering in January, Disc Medicine reports a strong financial position with $695 million in cash, providing runway into 2028.
Disc Medicine Advances Hematology Pipeline with Bitopertin NDA Plans and Phase 2 Trials
• Disc Medicine is preparing for an NDA submission for bitopertin in erythropoietic protoporphyria (EPP) following positive FDA feedback, potentially leading to accelerated approval.
• Phase 2 trials for DISC-0974 in anemia of myelofibrosis (MF) and chronic kidney disease (CKD) are progressing, with initial data expected in the second half of 2025.
• A Phase 2 study of DISC-3405 in polycythemia vera (PV) is set to begin in H1 2025, expanding Disc Medicine's portfolio in hematologic diseases.
• Disc Medicine's strengthened financial position, with a cash runway into 2027, supports the advancement of its clinical programs and strategic objectives.
Disc Medicine Secures $200M to Advance Clinical Trials of Hematologic Disease Therapies
• Disc Medicine has obtained a $200 million non-dilutive term loan to support its clinical trials and enhance financial flexibility.
• The funding will facilitate a confirmatory study of bitopertin for erythropoietic protoporphyria (EPP) and Phase II trials for DISC-0974 and DISC-3405 in anemia.
• A multiple-dose trial in anemia of non-dialysis dependent chronic kidney disease (NDD-CKD) is also planned with the secured financing.
• The company anticipates initiating a confirmatory trial of bitopertin in EPP by mid-2025, supported by this financial boost.
Disc Medicine Presents Positive Clinical Data Across Portfolio
Disc Medicine announced positive clinical data from its portfolio, including bitopertin for erythropoietic protoporphyria (EPP), DISC-0974 for myelofibrosis (MF) anemia, and DISC-3405 in healthy volunteers, showcasing significant advancements in treatment options for hematologic diseases.
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