Spero Therapeutics Announces GSK Files New Drug Application Resubmission to FDA For Tebipenem HBr To Treat Complicated Urinary Tract Infections

Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.