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Iterum Told by FDA of Deficiencies in Urinary Tract Drug

As part of its review of Iterum’s new drug application for sulopenem etzadroxil/probenecid, the FDA found deficiencies.
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Iterum Therapeutics  (ITRM) - Get Iterum Therapeutics Plc Report shares plunged Friday after it received a letter from the Food and Drug Administration saying that deficiencies were found in its treatment for urinary tract infections.

The FDA letter stated that as “part of their ongoing review of the Company’s New Drug Application for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post- marketing requirements/commitments at this time,” Iterum said.

Iterum shares traded at $1.38, down 40% in premarket trading Friday. They had soared 333% in the six months through Thursday.

“No details with respect to deficiencies were disclosed by the FDA in this notification, and the letter further states that the notification does not reflect a final decision on the information under review,” Iterum said.

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In a Jan. 21 letter to the company, “the FDA had assigned a Prescription Drug User Fee Act goal date of July 25, 2021 for completion of its review of the NDA,” Iterum said.

“The company intends to work with the FDA to understand the nature of the deficiencies and resolve them as quickly as possible.”