Ang NDA ng tradipitant para sa motion sickness ay may petsa ng PDUFA na Dec 30, 2025

Ang NDA ng tradipitant para sa motion sickness ay kasalukuyang nasa ilalim ng pagsusuri ng FDA na may target na petsa ng aksyon ng PDUFA na December 30, 2025. Ang NDA ng Bysanti para sa bipolar I disorder at schizophrenia ay nasa ilalim din ng pagsusuri na may petsa ng PDUFA na February 21, 2026. Ang BLA ng imsidolimab para sa generalized pustular psoriasis ay inaasahang isusumite sa Q4 2025.

Mahahalagang fact

Na-file: Okt 29, 2025, 08:08 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 · Inaprubahan

Sipi mula sa source

EX-99.1 2 vnda8-k10292025exhibit991.htm EX-99.1 Document Exhibit 99.1 Vanda Pharmaceuticals Reports Third Quarter 2025 Financial Results • Fanapt ® Q3 2025 net product sales increased by 31% to $31.2 million compared to Q3 2024 • Bysanti TM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026 • Tradipitant NDA for motion sickness under review by the FDA; PDUFA target action date of December 30, 2025 • Imsidolimab BLA in generalized pustular psoriasis expected to be submitted in Q4 2025 • Vanda announced collaborative framework with the FDA for resolution of certain disputes • Re-review of Vanda’s sNDA for HETLIOZ ® for the treatment of jet lag disorder by January 7, 2026 WASHINGTON – October 29, 2025 – Vanda

SEC 8-K