原始来源记录
重大PDUFA 日期确定
NRx Pharmaceuticals:计划于2026年第二季度提交NRX-100的NDA,PDUFA日期定于2026年
在Type C FDA会议后，NRx现在计划使用现有试验数据加上来自Osmind数据库的真实世界证据为NRX-100提交完整NDA。FDA表示终点可以支持完全批准而非加速批准；适应症扩大到更广泛的伴有自杀倾向的TRD人群。NDA提交目标为Q2 2026，旨在获得2026 PDUFA日期。
关键事实
来源摘录
EX-99.1 2 ex_921272.htm EXHIBIT 99.1 ex_921272.htm Exhibit 99.1 NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting. ● NRx together with Osmind, Inc. conducted an in-person meeting with leadership of the FDA Division of Psychiatry Products, Director of the FDA ● Company believes the meeting provides a clear path to filing an application for New Drug Approval of NRX-101 under already-awarded Fast Track Designation based on existing clinical trial data and Real World Evidence. ● FDA comments indicate that NRx’s desired endpoints could serve as a basis for full NDA approval, rather than serving as intermediate endpoints for more limited Accelerated Approval.