Spero Therapeutics Inc.’s (SPRO) Tebipenem HBr oral tablet, proposed for treatment in adult patients with certain bacterial microorganisms that cause complicated urinary tract infection, is at the FDA altar, with a decision anticipated on June 27, 2022.The U.S. regulatory agency notified the company in late March 2022 that it had detected problems in the New Drug Application for Tebipenem HBr during its ongoing review, which prevented discussion of labeling and post-marketing requirements/commitments at that time.Although the FDA has not yet made any final determination regarding approvability, it is expected that Tebipenem HBr might not make it to the finish line during this review cycle.Spero licensed Tebipenem HBr from Meiji Seika Pharma Co., Ltd. in 2017.Tebipenem HBr is marketed in Japan under brand name Orapenem for pediatric infections limited to pneumonia, otitis media and sinusitis by Meiji.SPRO closed Thursday’s (May 26, 2022) trading at $1.20.