Viridian: veligrotug BLA dalam Priority Review, PDUFA 30 Juni 2026

FDA Priority Review terhadap veligrotug BLA untuk TED sedang berlangsung dengan target tanggal tindakan PDUFA pada 30 Juni 2026. Perusahaan juga telah mengajukan MAA ke EMA pada Januari 2026 dan sedang mempersiapkan peluncuran potensial di AS pada pertengahan 2026 jika disetujui.

Fakta utama

Diajukan: 26 Feb 2026, 12.13
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: VRDNViridian Therapeutics
Aset: veligrotug
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 30 Jun 2026 · Disetujui

Kutipan sumber

EX-99.1 2 d105707dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2025 Financial Results - PDUFA target action date of June 30, 2026 for veligrotug for thyroid eye disease (TED); U.S. commercial preparations on track to support anticipated launch - - Marketing Authorization Application (MAA) for veligrotug for TED submitted to the European Medicines Agency (EMA) in January 2026 - - Phase 3 topline data readout for subcutaneous elegrobart (VRDN-003) REVEAL-1 and REVEAL-2 studies on track for Q1 and Q2 2026 in active and chronic TED, respectively - - Advanced VRDN-008 into phase 1 clinical trial in healthy volunteers; data on track for 2H 2026 - - Strong balance sheet with cash, cash equivalents, and short-t

SEC 8-K