原始来源记录
决策级FDA 批准
Milestone Pharmaceuticals 获得 FDA 批准 CARDAMYST（etripamil）鼻喷雾剂
FDA 已批准 CARDAMYST（etripamil）鼻喷雾剂用于将成人急性症状性 PSVT 发作转为窦性心律。该产品现已获批供患者自行给药，提供了一种新的非侵入性治疗选择，并在 RAPID 试验中证明了疗效。该批准使 Milestone 能够启动商业化推广活动，由一支 60 人的销售团队面向约 10,000 名处方医生。
关键事实
- 申报时间
- 2025年12月15日 13:56
- 事件
- FDA 批准
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2025年12月13日 · 已批准
- 现金
- 年末 1.06 亿美元
- 资金使用期
- 至 2027 年底
- 销售团队
- 60 名代表
- 备考现金
- 2 亿美元
来源摘录
EX-99.1 2 tm2533390d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 FDA Approval Investor Call December 15, 2025 Forward Looking Statements 2 Milestone Pharmaceuticals Approval Call for CARDAMYST | December 15, 2025 The Presentation contains forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words such as ‘‘aim,’’ ‘‘anticipate,’’ ‘‘assume,’’ ‘‘believe,’’ ‘‘contemplate,’’ ‘‘continue,’’ ‘‘could,’’ ‘ ‘de sign,’’ ‘‘due,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘goal,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘objective,’’ ‘‘plan,’’ ‘‘predict,’’ ‘‘positioned,’’ ‘‘potential,’’ ‘‘project,’’ ‘‘seek,’’ ‘‘ sho uld,’’ ‘‘target,’’ ‘‘will,’’ ‘‘would’’ (as well as other words or expressions referencing future events, conditions or circumstances