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CAMBRIDGE, Mass. - GSK has filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration for tebipenem HBr, an investigational oral carbapenem antibiotic developed by Spero Therapeutics, Inc. (NASDAQ:SPRO), according to a press release statement issued Friday. Spero, with a market capitalization of $129 million, has seen its shares surge 129% over the past year.
The antibiotic is being developed to treat complicated urinary tract infections, including pyelonephritis. The NDA resubmission will trigger a $25 million milestone payment to Spero, expected in the first quarter of 2026. According to InvestingPro data, this payment would be significant for the company, which currently holds more cash than debt on its balance sheet.
The application is supported by results from the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025 following a planned interim analysis. The trial results were presented at the IDWeek conference in October.
Spero has granted GSK exclusive license to commercialize tebipenem HBr globally, except for certain Asian territories where Meiji retains development and commercialization rights.
Select tebipenem HBr studies have been partially funded by the Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority.
Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections.
In other recent news, Spero Therapeutics, in collaboration with GSK, announced positive results from their Phase 3 trial for tebipenem HBr, a potential first-in-class oral antibiotic for complicated urinary tract infections. The pivotal PIVOT-PO trial, which was concluded early due to its efficacy, demonstrated that oral tebipenem HBr was non-inferior to the traditional intravenous treatment, imipenem-cilastatin, in hospitalized patients. The trial revealed a 58.5% overall success rate for the oral treatment, closely matching the 60.2% success rate of the intravenous option, with a slight adjusted treatment difference of -1.3%. These recent developments mark a significant milestone for Spero Therapeutics and its partner GSK in advancing treatment options for urinary tract infections.
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