一次情報の記録
GSKは2025年12月にtebipenem HBrのNDAをFDAに再提出した。2026年2月、GSKはFDAがPDUFA目標アクション日を2026年6月18日に設定したと発表した。このNDAは、2025年5月に有効性のために早期中止された第3相PIVOT-PO試験によって裏付けられている。
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