Spero Therapeutics Announces FDA Review of Tebipenem HBr NDA Resubmission

Reuters12-19

Spero <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces FDA Review of Tebipenem HBr NDA Resubmission

Spero Therapeutics Inc. announced that its partner, GSK, has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA resubmission follows positive results from the Phase 3 PIVOT-PO trial. This regulatory review triggers a $25 million milestone payment to Spero, expected in the first quarter of 2026. Select studies of tebipenem HBr have also received partial funding from federal agencies, including the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Spero Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9604668-en) on December 19, 2025, and is solely responsible for the information contained therein.

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