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.
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