After being rejected by the FDA in 2022, the New Drug Application for Tebeipenem HBr is back at the FDA altar, with a decision due on June 18, 2026.Tebipenem pivoxil as hydrobromide salt (Tebipenem HBr) is proposed as an oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis.The FDA had declined to approve Tebipenem HBr in June 2022, when it was under the aegis of Spero Therapeutics Inc. (SPRO) due to insufficient data to support its approval then. In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics for the development and commercialisation of Tebipenem HBr in all markets, except certain Asian territories. GSK resubmitted the NDA for Tebipenem HBr in December 2025, supported by results from a successful Phase 3 PIVOT-PO trial, and now awaits the regulatory decision. If approved, Tebipenem HBr would be the first oral carbapenem antibiotic in the US for patients who suffer from cUTIs.Spero is eligible to receive up to $351 million in additional potential regulatory, commercial, and sales milestone payments, as well as royalties related to Tebipenem HBr.SPRO closed Tuesday’s (June 2, 2026) trading at $2.83.