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FDA Approves Iterum Therapeutics' Orlynvah for Uncomplicated UTIs

• The FDA has approved Iterum Therapeutics' Orlynvah for treating uncomplicated urinary tract infections (UTIs) in adult women with limited oral antibacterial options. • This marks the first approved indication for Orlynvah and the first FDA-approved product for Iterum Therapeutics, a clinical-stage pharmaceutical company. • Iterum Therapeutics plans to pursue strategic transactions involving Orlynvah following the FDA approval, according to CEO Corey Fishman.

The Food and Drug Administration (FDA) has approved Iterum Therapeutics' new drug application for Orlynvah, a treatment for uncomplicated urinary tract infections (UTIs) caused by susceptible microorganisms in adult women who have limited or no alternative oral antibacterial drug options. The approval, announced Friday, marks a significant milestone for Iterum, representing its first FDA-approved product.

Strategic Transactions Planned

Following the FDA's decision, Iterum Therapeutics CEO Corey Fishman stated the company will renew its efforts to secure a strategic transaction involving Orlynvah. The approval is expected to enhance the drug's appeal to potential partners.

About Orlynvah

Orlynvah is an oral antibacterial drug specifically indicated for uncomplicated UTIs in adult women when other oral treatment options are limited. This approval addresses a critical need for patients who may have resistance to commonly prescribed antibiotics or who cannot tolerate them.
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Reference News

[1]
Iterum Therapeutics Shares Soar on FDA's Orlynvah Approval | Morningstar
morningstar.com · Oct 25, 2024

Iterum Therapeutics' stock surged 64% after FDA approval of Orlynvah, its treatment for uncomplicated urinary tract infe...

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