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Iterum Therapeutics Stock Shoots Higher As Sulopenem Application Review On Track

·1 min read
  • Iterum Therapeutics plc (NASDAQ: ITRM) has concluded a late-cycle meeting with the FDA related to its application for sulopenem etzadroxil/probenecid.

  • Sulopenem is under review as a treatment for uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.

  • The agency determined that an Advisory Committee meeting is not currently necessary and is continuously working toward the action date of July 25.

  • During the meeting, the FDA shared issues still under review, and the company responded.

  • In April, the company disclosed that the FDA needed additional time to review its sulopenem application, and FDA Antimicrobial Drugs Advisory Committee June 2 meeting has been postponed.

  • Price Action: ITRM shares are up 22.8% at $1.51 during the premarket session on the last check Friday.

  • Related content: Benzinga's Full FDA Calendar

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