Spero Therapeutics (SPRO) Wins FDA Approval for Utebzi, First Oral Carbapenem for Complicated UTIs

Spero Therapeutics (SPRO) announced June 17, 2026, that the U.S. Food and Drug Administration (FDA) approved Utebzi (tebipenem HBr) for treating complicated urinary tract infections (cUTI) and pyelonephritis in adults. This marks Utebzi as the first and only oral carbapenem approved for this indication, sending Spero shares higher. The FDA's decision follows a New Drug Application (NDA) resubmission and is supported by data from the Phase 3 ADAPT-PO trial. Spero anticipates launching Utebzi in the fourth quarter of 2026. The company previously granted GSK plc (GSK) exclusive commercialization rights for Utebzi outside of the U.S.