Viridian mengajukan BLA untuk veligrotug pada penyakit mata tiroid

Viridian mengajukan veligrotug BLA ke FDA pada Oktober 2025 dengan permintaan Priority Review; jika disetujui, perusahaan memperkirakan peluncuran komersial di AS pada pertengahan 2026. Pengajuan ini mengikuti data positif Fase 3 dari THRIVE dan THRIVE-2 dan didukung oleh Breakthrough Therapy Designation yang diberikan pada Mei 2025.

Fakta utama

Diajukan: 5 Nov 2025, 12.09
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: VRDNViridian Therapeutics
Aset: veligrotug
Sumber: SEC 8-K
Keyakinan: Bersumber
posisi kas: $887,9 juta
Pencapaian royalti: $115 juta
total akses modal: $889 juta
proceeds ekuitas bruto: $289,1 juta
Pembayaran awal pendanaan royalti: $55 juta

Kutipan sumber

EX-99.1 2 d33707dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress - Completed a comprehensive set of financing transactions in October 2025, securing access to up to $889 million of potential capital across equity, royalty, and credit - - Successful October submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug in thyroid eye disease (TED) and preparing for an anticipated U.S. commercial launch in mid-2026, if approved, under a Priority Review timeline - - Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollm

SEC 8-K