Spero Therapeutics (NASDAQ:SPRO) announced today that its development partner, GSK (NYSE:GSK), has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, a treatment for complicated urinary tract infections (cUTI), including pyelonephritis.
The NDA resubmission is supported by positive data from the Phase 3 PIVOT-PO trial, which was stopped early in May 2025 for efficacy.
The trial data was presented at IDWeek in October 2025, reinforcing the treatment’s potential for addressing this serious infection.
The resubmission triggers a $25 million milestone payment to Spero, expected in the first quarter of 2026.
GSK holds exclusive commercialization rights to tebipenem HBr outside of certain Asian territories, where Meiji retains the rights.
The resubmission of the NDA represents a significant step forward in bringing this promising treatment to market, potentially offering a new therapeutic option for patients suffering from cUTI.