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Iterum Stock Nosedives As FDA Flags Deficiencies In Sulopenem Application

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  • ​​​​​Iterum Therapeutics plc (NASDAQ: ITRM) has received a letter from the FDA regarding the sulopenem etzadroxil/probenecid marketing application review for uncomplicated urinary tract infections.

  • The agency has identified deficiencies that preclude the discussion of labeling and post-marketing requirements/commitments at this time.

  • The FDA did not disclose the details regarding deficiencies in this notification. The letter further states that the notification does not reflect a final decision on the information under review.

  • The FDA has assigned a goal date of July 25 for completion of its review of the NDA.

  • The company said it intends to work with the FDA to understand the nature of the deficiencies and resolve them soon.

  • Price Action: ITRM shares are down 39.7% at $1.38 during the premarket session on the last check Friday.

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