Iterum Says FDA Found Deficiencies in Drug Application

By Matt Grossman

Iterum Therapeutics Plc said Thursday that U.S. regulators have found deficiencies in its review of a drug that the company is developing.

The U.S. Food and Drug Administration's findings relate to sulopenem etzadroxil/probenecid, a candidate drug to treat urinary tract infections. The deficiencies found "preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time," Iterum said. The company added that the FDA didn't provide further details about the deficiencies.

Iterum said it plans to work with the FDA to resolve the deficiencies.

Shares were down 29% in premarket trading.

Write to Matt Grossman at [e-mail]

(END) Dow Jones Newswires

07-02-21 0629ET