MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The response follows a Type A meeting rece ...

MONTREAL and CHARLOTTE, N.C., June 16, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The response follows a Type A meeting recen ...

核心事件 - Milestone Pharmaceuticals收到FDA关于CARDAMYST鼻喷雾剂NDA的完全回应函(CRL) [1] - CRL未质疑药物临床安全性或疗效 但提出两项CMC相关问题需解决 [2] - 公司股价在CRL发布后暴跌66.2% 年内累计下跌67.8% 同期行业增长2.2% S&P 500指数下跌5.6% [2][7] 监管问题细节 - 首要问题涉及亚硝胺杂质 需根据新发布指南补充数据 [3] - 次要问题涉及变更所有权的检测设施 需重新评估cGMP合规性 [4] 公司应对措施 - 计划申请Type A会议与FDA沟通解决路径 [9] - 2023年12月曾收到拒绝提交函 要求修改初始NDA材料 [9] - 截至2024年底持有6970万美元现金及短期投资 具备应对监管挑战的财务缓冲 [10] 市场预期 - 分析师保持谨慎乐观 认为问题可解决 预计商业化推迟至2026年 [5][8] - 当前障碍属暂时性 无临床问题预示最终获批潜力 [11] 行业对比 - 医疗设备公司Masimo(Zacks排名1)2025年预期增长率20% 年内股价上涨1.4% [13] - 医药分销商Cencora(Zacks排名2)长期增长率12.1% 年内股价上涨23.5% [14] - 波士顿科学(Zacks排名2)长期增长率13.3% 年内股价上涨13.4% [15]