Spero Therapeutics Announces FDA Review of Tebipenem HBr NDA Resubmission
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Spero Therapeutics Inc. announced that its partner, GSK, has resubmitted a New Drug Application (NDA) to the FDA for tebipenem HBr, an oral antibiotic for complicated urinary tract infections. The resubmission follows positive Phase 3 trial results and triggers a $25 million milestone payment to Spero in Q1 2026. Some studies received partial federal funding.
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