原始出處紀錄
GSK 於 2025 年 12 月向 FDA 重新提交 tebipenem HBr 的 NDA。2026 年 2 月，GSK 宣布 FDA 將 PDUFA 目標行動日期定為 2026 年 6 月 18 日。該 NDA 獲得 2025 年 5 月因療效而提前停止的 Phase 3 PIVOT-PO 試驗支持。
EX-99.1 2 d107475dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Spero Therapeutics Announces Fourth Quarter and Full Year 2025 Operating Results and Provides a Business Update • Spero announced the resubmission of tebipenem HBr New Drug Application (NDA) to the FDA for complicated urinary tract infections (cUTI), including pyelonephritis in December 2025 • In February, Spero’s licensing partner, GSK announced the FDA had set the PDUFA date as June 18, 2026 • Spero estimates cash and cash equivalents as of December 31, 2025 are sufficient to fund current operations into 2028 CAMBRIDGE, Mass., March 26, 2026 — Spero Therapeutics , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high