Iterum Therapeutics Nears August Launch of First Branded UTI Antibiotic in 25 Years

Iterum Therapeutics plc, a pharmaceutical company specializing in next-generation oral and IV antibiotics, is on track to commercially launch ORLYNVAH™ in the U.S. by the end of August 2025 for the treatment of uncomplicated urinary tract infections (uUTIs), marking the first branded antibiotic for uUTIs in over 25 years. ORLYNVAH™ is notable as the only FDA-approved oral penem antibiotic in the U.S., addressing rising antimicrobial resistance and providing treatment options for infections caused by resistant Gram-negative bacteria, including ESBL-producing Enterobacterales. The company has partnered with EVERSANA Life Science Services for commercialization efforts, including sales, marketing, logistics, and regulatory support, and has entered into a manufacturing and supply agreement to support the launch. Financially, Iterum reported mixed results for the second quarter of 2025 with increased operating expenses but a reduction in loss per share compared to the previous year, and it holds $13 million in cash with projections to support operations into 2026. Despite these preparations, the company’s overall financial health shows challenges, including a negative earnings per share and poor operational scores, though it maintains a strong quick ratio indicating liquidity. Iterum’s strategic focus remains on bringing ORLYNVAH™ to market to address critical unmet needs in antibiotic treatment amid growing resistance concerns.