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DUBLIN/CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM), a $37.47 million market cap pharmaceutical company, announced on Wednesday the U.S. commercial launch of ORLYNVAH (sulopenem etzadroxil and probenecid) oral tablets, the first oral penem antibiotic available in the United States. According to InvestingPro data, the company maintains a healthy current ratio of 2.69, indicating strong short-term liquidity as it enters this crucial commercialization phase.
The Food and Drug Administration approved ORLYNVAH in October 2024 for adult women with uncomplicated urinary tract infections (uUTIs) caused by specific bacteria when limited or no alternative oral antibacterial options exist.
This marks the first new branded product for uUTIs introduced in the U.S. in more than 25 years, according to the company’s press release statement.
Urinary tract infections affect 60% of women during their lifetime, with 44% experiencing three or more episodes annually. A 2024 U.S. study of approximately 150,000 patients with uncomplicated UTIs found that 57% of initial infections were resistant to at least one antibiotic class, while 13% were resistant to three or more.
"The availability of ORLYNVAH is tremendous news for clinicians and patients alike," said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease at St. Raphael Campus Yale New Haven Hospital. "For patients who currently have limited treatment options, ORLYNVAH provides a long overdue oral alternative that allows for treatment in the community."
Iterum Therapeutics is launching a copay savings program allowing eligible patients to obtain ORLYNVAH for as little as $25.
"Our mission is to create new antibiotics for patients and to be a treatment alternative to address substantial unmet medical needs in the community," said Corey Fishman, Chief Executive Officer of Iterum Therapeutics.
The company received Qualified Infectious Disease Product and Fast Track designations for sulopenem in seven indications.
In other recent news, Iterum Therapeutics has entered into a Product Commercialization Agreement with EVERSANA Life Science Services. This agreement, effective from June 6, 2025, is a significant development for Iterum Therapeutics, focusing on the commercialization of its approved product, ORLYNVAH, in the United States. EVERSANA will provide a comprehensive range of services, including sales and commercial operations, marketing, logistics, and channel management. Additionally, EVERSANA will handle regulatory and medical affairs, among other activities, to support the product’s market presence. Iterum Therapeutics US Limited, a subsidiary of Iterum, will maintain control over legal, regulatory, and manufacturing responsibilities for ORLYNVAH. Furthermore, Iterum will record sales of the product in the U.S., ensuring that it retains oversight of the financial aspects of this venture. This collaboration marks a pivotal step in Iterum’s strategy to enhance its market operations and expand its reach in the pharmaceutical industry.
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