Spero Therapeutics, Inc.

Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company that identifies and develops new treatments for rare diseases and diseases with significant unmet medical needs. Since its founding in 2013, the company has concentrated its efforts and financial resources on acquiring and developing product and technology rights, building its intellectual property portfolio, and conducting research and development for its product candidates. Spero Therapeutics, Inc. does not have any products approved for sale and has not generated revenue from product sales. The company's clinical-stage product candidate, tebipenem HBr, has completed a second Phase 3 trial. This product has the potential to be the first oral carbapenem to treat adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain microorganisms. In September 2022, Spero Therapeutics, Inc. entered into an exclusive license agreement with GSK for the development, manufacture, and commercialization of tebipenem HBr, which included the transfer of the Investigational New Drug (IND) and New Drug Application (NDA) ownership to GSK. In May 2025, Spero Therapeutics, Inc. and GSK announced that the pivotal Phase 3 PIVOT-PO trial for tebipenem HBr met its primary endpoint and was stopped early due to efficacy. Results from this trial were presented in October 2025 at IDWeek. GSK submitted the trial data as part of an NDA Class 2 resubmission to the FDA in December 2025, which the FDA accepted. GSK reported that the Prescription Drug User Fee Act (PDUFA) date is set for June 18, 2026. In March 2025, following a reprioritization of its programs, Spero Therapeutics, Inc. announced it was no longer pursuing a Phase 2 clinical trial for SPR206, an investigational product candidate for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by carbapenem-resistant pathogens, and has ceased further development of this program. Additionally, in November 2025, the company announced it ceased development of SPR720, a product candidate for the first-line treatment of NTM-PD.