一次情報の記録
FDAはtebipenem HBr NDAのPDUFA日を2026年6月18日に設定した。NDAは2025年12月にGSKにより提出され、2025年5月に有効性により早期中止された第3相PIVOT-PO試験により裏付けられている。
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