Vertex on track untuk pengajuan BLA H1 2026 povetacicept di IgAN

8-K menyatakan Vertex on track untuk menyelesaikan pengajuan BLA untuk persetujuan akselerasi AS povetacicept di IgAN pada paruh pertama 2026. Ini menetapkan tonggak pengajuan regulasi yang konkret untuk aset tersebut. Tidak ada hasil atau tanggal regulasi lain yang disediakan dalam dokumen.

Fakta utama

Diajukan: 12 Feb 2026, 21.04
Peristiwa: Permohonan diajukan
Arah: Netral
Perusahaan: VRTXVertex Pharmaceuticals
Aset: povetacicept
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 ex-991_q42025.htm EX-99.1 Document Vertex Reports Fourth Quarter and Full Year 2025 Financial Results — Full year total revenue of $12.0 billion, a 9% increase compared to full year 2024; fourth quarter total revenue of $3.19 billion, a 10% increase compared to fourth quarter 2024 — — Company provides full year 2026 total revenue guidance of $12.95 billion to $13.1 billion, with non-CF products expected to contribu te $500 million or more in reve nue — — Broad mid- and late-stage clinical pipeline accelerates with multiple proof-of-concept and pivotal programs advancing; on track to complete BLA filing for U.S. accelerated approval of povetacicept in IgAN in the first half of 2026 — BOSTON -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financ

SEC 8-K