Business
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
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Spero announced the resubmission of tebipenem HBr New Drug Application (NDA) to the FDA for complicated urinary tract infections (cUTI), including pyelonephritis in December 2025In 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 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year ended December 31, 2025, and provided a business update. “2025 was marked by important progress across the tebipenem HBr program in cUTI, including completion of the global Phase 3 trial and resubmission of the NDA,” said Esther Rajavelu, President and CEO of Spero. “With our licensing partner GSK’s global leadership in anti-infectives, tebipenem HBr, if approved, has the potential to address an important need and meaningfully improve treatment options for patients with cUTI. We look forward to the FDA’s decision in late June as we continue to execute our business strategy to deliver innovative therapies.” Spero remains focused on completing its obligations under its License Agreement with GSK while advancing other corporate activities, including exploring opportunities to expand its portfolio of clinical-stage product candidates. Program Update Tebipenem HBr Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to provide an effective oral therapeutic alternative to IV carbapenems. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In December 2025, GSK resubmitted the tebipenem HBr NDA to the FDA. In February 2026, GSK announced that the FDA set the Prescription Drug User Fee Act (“PDUFA”) date as June 18, 2026. The NDA is supported by results from the successful Phase 3 PIVOT-PO trial that evaluated tebipenem HBr. The trial, which was stopped early for efficacy in May 2025, demonstrated non-inferiority of tebipenem HBr ...