VNDA: Bysanti NDA PDUFA ditetapkan untuk 21 Februari 2026

FDA menerima NDA Bysanti (milsaperidone) untuk gangguan bipolar I dan skizofrenia serta menetapkan tanggal tindakan target PDUFA 21 Februari 2026. Keputusan ini akan menentukan apakah perusahaan dapat memperluas waralaba psikiatrinya dengan produk antipsikotik kedua.

Fakta utama

Diajukan: 11 Feb 2026, 21.05
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: VNDAVanda Pharmaceuticals
Aset: imsidolimab
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 12 Des 2026 · Disetujui

Kutipan sumber

EX-99.1 2 vnda8-k2112026exhibit991.htm EX-99.1 Document Exhibit 99.1 Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results • Full year 2025 Fanapt ® net product sales increased by 24% to $117.3 million compared to full year 2024 • Full year 2025 total revenues increased by 9% to $216.1 million compared to full year 2024 • NEREUS TM (tradipitant) approved for the prevention of vomiting induced by motion • Bysanti TM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 WASHINGTON – February 11, 2026 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the fourth quarter and full year ended December 31, 2025. “2025 showed strong mom

SEC 8-K