SPERO THERAPEUTICS, INC. - FORM 8-K Filing

On December 19, 2025, Spero Therapeutics, Inc. announced that its development partner, GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK), has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr. This investigational oral carbapenem antibiotic is being developed for the treatment of complicated urinary tract infections, including pyelonephritis. The NDA resubmission triggers a $25 million milestone payment to Spero Therapeutics under its license agreement with GSK, which is anticipated to be received in the first quarter of 2026. The filing also includes standard forward-looking statements and disclaimers regarding risks and uncertainties associated with drug development, regulatory approval, commercialization, and the company's financial resources.