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FDA Calendar - Spero Therapeutics, Inc.

Company Name Spero Therapeutics, Inc.
SPRO
Drug Name Tebipenem HBr (NDA)
Event Name FDA decision on tebipenem HBr as oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis
Event Date 06/18/2026
Outcome Date
Outcome pending
Drug Status 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.
Rival Drugs If approved, tebipenem HBr could be the first oral
carbapenem antibiotic for patients in the US who suffer from cUTIs
Market Potential
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