GSK files NDA resubmission for tebipenem HBr, triggers $25 million milestone.

Spero Therapeutics' development partner GSK has filed a New Drug Application (NDA) resubmission to the US FDA for tebipenem HBr, an oral carbapenem antibiotic for cUTI and pyelonephritis. The submission triggers a $25 million milestone payment to Spero, expected in Q1 2026. The NDA is supported by results from the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025.