Spero Therapeutics Shares Jump 16% After FDA Clears First Oral Carbapenem for cUTIs
SPRO•Spero Therapeutics shares climbed 16% after the FDA approved Utebzi, the first oral carbapenem antibiotic for complicated urinary tract infections in adults lacking suitable oral treatments. The drug targets more than three million U.S. cUTI cases and underpins a $6 billion market, with Utebzi set to launch by year-end.
1. FDA Approval Spurs Share Rally
Spero Therapeutics shares rose 16% following FDA approval of Utebzi, marking the first oral carbapenem antibiotic indicated for complicated urinary tract infections, including pyelonephritis, in adults with limited oral treatment options.
2. Phase III PIVOT-PO Trial Results
The Phase III PIVOT-PO study demonstrated non-inferiority of tebipenem pivoxil to intravenous imipenem-cilastatin, with overall success rates of 58.5% versus 60.2% and an adjusted treatment difference of -1.3% (95% CI: -7.5%, 4.8%), and a safety profile comparable to existing carbapenems.
3. Commercial Launch and Market Potential
Utebzi is expected to launch in the U.S. by year-end, addressing over three million complicated UTI cases annually and a healthcare burden surpassing $6 billion. The product is developed under GSK’s global licensing agreement with Spero, supported by BARDA funding for late-stage development.
