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]

As filed with the U.S. Securities and Exchange Commission on July 25, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 180 Life Sciences Corp. (Exact name of registrant as specified in its charter) Delaware 2834 90-1890354 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) 3000 El Camino Re ...

As filed with the U.S. Securities and Exchange Commission on June 16, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 180 Life Sciences Corp. (Exact name of registrant as specified in its charter) Delaware 2834 90-1890354 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification Number) Palo Alto, CA ...