Core Insights - Spero Therapeutics announced that its development partner GSK has resubmitted a New Drug Application (NDA) for tebipenem HBr to the FDA, which is intended for treating complicated urinary tract infections (cUTI) [1][2] - The NDA resubmission is accompanied by a $25 million milestone payment to Spero, expected in Q1 2026 [1] Group 1: NDA Resubmission and Trial Results - The NDA resubmission is based on positive results from the Phase 3 PIVOT-PO trial, which was halted early for efficacy in May 2025 [2] - Results from the trial were presented at the IDWeek conference in October 2025 [2] Group 2: Licensing and Development Rights - Spero has granted GSK an exclusive license to commercialize tebipenem HBr globally, except for certain Asian territories where Meiji retains rights [2] Group 3: Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [4]