1차 출처 기록
GSK는 2025년 12월에 tebipenem HBr NDA를 FDA에 재제출했습니다. 2026년 2월, GSK는 FDA가 PDUFA 목표 조치 날짜를 2026년 6월 18일로 설정했다고 발표했습니다. NDA는 2025년 5월에 효능으로 조기 중단된 Phase 3 PIVOT-PO 시험에 의해 뒷받침됩니다.
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