Disc Medicine mengajukan NDA untuk bitopertin dalam EPP

Disc Medicine mengajukan NDA untuk persetujuan dipercepat bitopertin dalam EPP pada 29 September 2025. FDA memberikan Commissioner’s National Priority Voucher, yang mempersingkat periode tinjauan NDA yang diharapkan menjadi 1-2 bulan. Perusahaan kini memperkirakan potensi persetujuan dan peluncuran di AS pada akhir 2025 atau awal 2026.

Fakta utama

Diajukan: 20 Okt 2025, 10.38
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: IRONDisc Medicine
Aset: bitopertin
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 d272031dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Disc Medicine Provides Update on Hematology Portfolio and Outlines Near-Term Business Objectives and Anticipated Milestones • Submitted a New Drug Application (NDA) for accelerated approval of bitopertin in erythropoietic protoporphyria (EPP) on September 29, 2025, and subsequently was awarded the FDA Commissioner’s National Priority Voucher (CNPV), a program designed to shorten the expected NDA review period to 1-2 months • Acceleration of ongoing efforts to support the potential earlier approval and commercialization of bitopertin for EPP in the US, expected in late 2025 or early 2026 • Plans to advance DISC-0974 for anemia of myelofibrosis (MF) and DISC-3405 for polycythemia vera (PV) deeper into development and to contin

SEC 8-K