11:42 AM EDT, 10/25/2024 (MT Newswires) -- Iterum Therapeutics ( ITRM ) shares gained more than 36% in recent Friday trading after the company said the US Food and Drug Administration has approved its new drug application for Orlynvah as a treatment for uncomplicated urinary tract infections in women.

The approval was based on data from its clinical development program, including the results from two phase 3 trials where Orlynvah demonstrated "superiority" to other treatments, the company said.

Iterum said the approval marks the first indication for Orlynvah, making it the company's first FDA-approved product.

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