原始出處紀錄
EMA CHMP 提供書面科學建議,確認已完成的 Phase 3 研究、安全性資料套件及非臨床資料可接受用於軟疣的上市授權申請,無需額外 Phase 3 試驗。此監管回饋免除進一步關鍵性研究的需求,並為歐洲 2 歲及以上成人和兒童患者提供直接 MAA 提交途徑。
EX-99.1 2 d99039dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Verrica Pharmaceuticals Reports Third Quarter 2025 Financial Results – Company reports $14.3 million in revenue in Q3’25, consisting of $3.6 million in YCANTH ® revenue and $10.7 million of license and collaboration revenue – – Reports positive feedback from the FDA and alignment regarding the study design of a Phase 3 program for VP-315 in basal cell carcinoma; Company presented new data on VP-315 at the recent Society for Immunotherapy of Cancer conference – – Received positive feedback from European Medicines Agency that supports a Marketing Authorization Application filing for YCANTH for molluscum without need for additional Phase 3 studies – – Received $10 million cash milestone payment for approval of YCANTH for mollus
Verrica 啟動 YCANTH 治療常見疣的 Phase 3 試驗;首名患者於 2025 年 12 月給藥