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.
The FDA’s letter didn’t “reflect a final decision on the information under review,” according to Iterum. But it seems a foregone conclusion that any potential approval for sulopenem etzadroxil/probenecid will be later than expected.
In May, Iterum met with the FDA, and the agency shared some issues that were still under review at that time. The company said that it had responded to those issues, and that the FDA decided not to convene an advisory committee meeting to review the application for approval of sulopenem etzadroxil/probenecid.
Iterum now plans to work with the FDA to learn more about the deficiencies mentioned in the agency’s letter. CEO Corey Fishman said that his company will “resolve the issues as expeditiously as possible in order to continue advancing this much needed antibiotic.”
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