Iterum Therapeutics (ITRM) said Friday that the US Food and Drug Administration has referred its new drug application for oral sulopenem to an advisory committee.
A committee meeting has been proposed for Sept. 9, during which the committee will discuss antimicrobial stewardship issues and the appropriate target patient population for the drug candidate, according to Iterum.
Oral sulopenem was submitted as a potential treatment for uncomplicated urinary tract infections in adult women, Iterum said.
Shares of the company were up 6% in Friday premarket activity.
Price: 1.2200, Change: +0.07, Percent Change: +6.09
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