VNDA: Bysanti NDA PDUFA itinakda para sa February 21, 2026

FDA tinanggap ang Bysanti (milsaperidone) NDA para sa bipolar I disorder at schizophrenia at nagtalaga ng PDUFA target action date na February 21, 2026. Ang desisyon ay magpapasya kung ang kompanya ay makakapagpalawak ng psychiatry franchise nito gamit ang pangalawang antipsychotic product.

Mahahalagang fact

Na-file: Peb 11, 2026, 09:05 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: VNDAVanda Pharmaceuticals
Asset: imsidolimab
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Dis 12, 2026

Sipi mula sa source

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