Disc Medicine, Inc. announced significant advancements in its clinical programs and financial status during the first quarter of 2025. The company is on track to submit a New Drug Application (NDA) ...
Pursuing a traditional approval path for bitopertin in erythropoietic protoporphyria (EPP); Phase 3 APOLLO study is expected to complete enrollment in March 2026 with topline data expected in Q4 2026 ...
Presented positive data for all three programs at the European Hematology Association (EHA) 2024 Congress; demonstrated potential efficacy for bitopertin in erythropoietic protoporphyria (EPP) and ...
“2024 was a transformative year for Disc, marked by the achievement of several milestones, most notably opening the door to a potential accelerated approval for bitopertin based on Phase 2 results ...
The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating ...
(RTTNews) - Disc Medicine Inc. (IRON) announced positive additional data from an ongoing Phase 1b study of DISC-0974 in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia ...
Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025; Awarded the FDA Commissioner’s National Priority Voucher ...
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