CAMBRIDGE, Mass. — December 19, 2025 — Leads & Copy — Spero Therapeutics, Inc. (Nasdaq: SPRO) announced today that GSK, its development partner, has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr. This investigational oral carbapenem antibiotic is being developed to treat complicated urinary tract infections (cUTI), including pyelonephritis.
The NDA resubmission triggers a $25 million milestone payment to Spero, which is expected to be received in Q1 2026.
The resubmission is based on results from the Phase 3 PIVOT-PO trial (NCT06059846), which was stopped early for efficacy in May 2025 after a planned interim analysis. The trial results were presented at the IDWeek conference in October 2025.
Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains development and commercialization rights.
Select tebipenem HBr studies have received partial funding from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.
Spero Therapeutics, located in Cambridge, Massachusetts, is focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need.
Investor Relations Contact:
Shai Biran, PhD
IR@Sperotherapeutics.com
Media Inquiries:
media@sperotherapeutics.com
Source: Spero Therapeutics
