Registro de fuente primaria
La FDA fijó la fecha PDUFA para la NDA de tebipenem HBr para el 18 de junio de 2026. La NDA fue presentada por GSK en diciembre de 2025 y está respaldada por el ensayo de fase 3 PIVOT-PO, que se detuvo anticipadamente por eficacia en mayo de 2025.
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