Shares of Iterum Therapeutics (NASDAQ: ITRM) had crashed 35.5% as of 11:08 a.m. EDT on Friday. The big decline came after the company announced after the market close on Thursday that it had received a letter from the Food and Drug Administration (FDA). This letter, the company said, "identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time" for its antibiotic candidate sulopenem etzadroxil/probenecid in treating uncomplicated urinary tract infections.
Iterum had hoped to win FDA approval for sulopenem etzadroxil/probenecid this month. The agency previously assigned a Prescription Drug User Fee Act ( PDUFA ) date of July 25 for the completion of its review of the company's regulatory filing for the antibiotic.
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Why Iterum Therapeutics Stock Is Crashing Today