1차 출처 기록
FDA가 tebipenem HBr NDA의 PDUFA 날짜를 2026년 6월 18일로 설정했습니다. NDA는 2025년 12월 GSK에 의해 제출되었으며, 2025년 5월 효능으로 조기 종료된 Phase 3 PIVOT-PO 시험에 의해 뒷받침됩니다.
EX-99.1 2 d147628dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Spero Therapeutics Announces First Quarter 2026 Operating Results and Provides Business Update • New Drug Application (NDA) for tebipenem HBr for complicated urinary tract infections (cUTI), including pyelonephritis, is under review at the FDA, with PDUFA date of June 18, 2026 • Spero maintains its cash runway guidance into 2028 CAMBRIDGE, Mass., May 13, 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 unmet need, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “We continue to make solid progress on the tebipenem HBr program al