原始来源记录
重大EMA 意见
Verrica 获得 EMA 积极反馈，支持 YCANTH MAA 申报
EMA CHMP 提供书面科学建议，确认已完成的 III 期研究、安全性数据包和非临床数据可用于软疣的上市许可申请，无需额外 III 期试验。该监管反馈消除了进一步关键研究的需求，并为欧洲 2 岁及以上成人和儿童患者提供直接 MAA 提交途径。
关键事实
- 申报时间
- 2025年11月14日 21:25
- 事件
- EMA 意见
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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