Spero Therapeutics says FDA approves Utebzi oral antibiotic for complicated UTIs in adults

• FDA cleared Utebzi (tebipenem pivoxil) for adults with complicated UTIs, including pyelonephritis, with limited or no alternative oral options.
• GSK holds exclusive global rights under a licensing deal with Spero Therapeutics, excluding select Asian territories.
• Decision based on Phase III PIVOT-PO data showing non-inferiority versus IV imipenem-cilastatin; overall response 58.5% vs 60.2%.
• Launch targeted by end-2026, positioning Utebzi as the first oral carbapenem available in the US.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-26-277506), on June 22, 2026, and is solely responsible for the information contained therein.