原始来源记录
GSK 于 2025 年 12 月向 FDA 重新提交了 tebipenem HBr NDA。2026 年 2 月，GSK 宣布 FDA 将 PDUFA 目标行动日期定为 2026 年 6 月 18 日。该 NDA 由 2025 年 5 月因疗效提前终止的 3 期 PIVOT-PO 试验支持。
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