GSK files NDA resubmission for tebipenem HBr, triggers $25 million milestone.
ByAinvest
Friday, Dec 19, 2025 8:07 am ET1min read
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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.
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