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GSK resubmitted the tebipenem HBr NDA to FDA in December 2025. In February 2026, GSK announced the FDA set the PDUFA target action date as June 18, 2026. The NDA is supported by the Phase 3 PIVOT-PO trial that was stopped early for efficacy in May 2025.
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