Iterum Therapeutics Shares Soar on FDA's Orlynvah Approval

Dow Jones

Oct 26, 2024

By Dean Seal

Shares of Iterum Therapeutics surged after federal regulators approved the use of its urinary tract infection treatment Orlynvah.

The stock was up 64% at $1.92 around noon ET, closer to where it started the year.

The clinical-stage pharmaceutical company said Friday that the Food and Drug Administration has approved its new drug application for Orlynvah as a treatment for uncomplicated urinary tract infections caused by certain microorganisms in adult women with limited or no alternative oral antibacterial treatment options.

This is the first approved indication for Orlynvah and Iterum's first FDA-approved product.

Chief Executive Corey Fishman said that with the approval, Iterum will renew efforts to land a strategic transaction involving Orlynvah.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

October 25, 2024 12:04 ET (16:04 GMT)

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