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Spero Announces NDA Resubmission of Tebipenem HBr by GSK to the FDA for the Treatment of Complicated Urinary Tract Infections, Including Pyelonephritis
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the tre
About this update from Spero Therapeutics, Inc.
[{"type":"image","alt":"Spero Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Spero Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":108,"url":"https://media.zenfs.com/en/globenewswire.com/6fe4b8bd1b5673c609e8e3cb8c688861"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/NZ7Kj4X.syHvrTwbJDWHqg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/6fe4b8bd1b5673c609e8e3cb8c688861","width":300,"height":108}},"lazy":false},{"type":"text","content":"CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis. The NDA submission triggers a $25 million milestone payment to Spero, expected to be received in Q1 2026.","length":691,"tagName":"p"},{"type":"text","content":"The NDA resubmission is supported by results from the successful Phase 3 PIVOT-PO trial (NCT number – NCT06059846). The trial was stopped early for efficacy in May, 2025 following a planned interim analysis. Trial results were presented as a late breaker at the IDWeek conference in October 2025.","length":296,"tagName":"p"},{"type":"text","content":"Spero has granted GSK an exclusive license to commercialize tebipenem HBr in all territories except for certain Asian territories, where Meiji retains development and commercialization rights.","length":192,"tagName":"p"},{"type":"text","content":"Tebipenem HBr Research SupportSelect tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.","length":310,"tagName":"p"},{"type":"text","content":"About Spero TherapeuticsSpero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmace...