Disc Medicine mengajukan NDA untuk bitopertin dalam EPP; menerima CNPV

Disc mengajukan NDA untuk bitopertin yang mencari persetujuan dipercepat di EPP pada 29 September 2025. FDA memberikan Commissioner’s National Priority Voucher, yang mempersingkat tinjauan yang diharapkan menjadi 1-2 bulan sejak penerimaan. Perusahaan mempercepat persiapan peluncuran untuk potensi persetujuan AS pada akhir 2025 atau awal 2026.

Fakta utama

Diajukan: 6 Nov 2025, 13.33
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: IRONDisc Medicine
Aset: bitopertin
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 iron-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business Update • 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 (CNPV), which is designed to shorten the expected NDA review period to 1-2 months from NDA acceptance • 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 • Initial data from Phase 2 study of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at the American Society of Hematology (ASH) conference in December • Progr

SEC 8-K