原始来源记录
重大申请已受理
Disc Medicine：Bitopertin NDA 于 11 月 28 日获 CNPV 试点受理
FDA 于 11 月 28 日受理 bitopertin NDA。该申请获选进入 Commissioner’s National Priority Voucher 试点计划，预计审评周期缩短至 1-2 个月，目标行动日期维持在 2026 年 1 月底前。
关键事实
- 申报时间
- 2025年12月8日 13:40
- 事件
- 申请已受理
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 iron-ex99_1.htm EX-99.1 2025 ASH Management Call December 7, 2025 Confidential Exhibit 99.1 Disclaimer and FLS This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to: (i) the registrational pathway for bitopertin, including the potential for accelerated approval, benefits of the Commissioner’s National Priority Voucher (CNPV) pilot program, and the anticipated review period and action date; (ii) the potential commercial launch of bitopertin, including commercial readiness activities and the timeline for availability of drug supply; (iii) the timing, progress and results of preclinical studies and