Spero Announces FDA Resubmission of Tebipenem HBr for Complicated UTIs Treatment

Spero Therapeutics' partner GSK has resubmitted a New Drug Application to the FDA for tebipenem HBr, an oral carbapenem antibiotic for treating complicated urinary tract infections. The submission triggers a $25 million milestone payment to Spero, expected in Q1 2026. The resubmission is supported by results from the successful Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025.