Iterum Therapeutics (ITRM) Jumps 87% on FDA Approval for UTI Treatment ORLYNVAH™

Iterum Therapeutics (Nasdaq: ITRM) has received FDA approval for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited oral treatment options. ORLYNVAH™ becomes the first oral penem antibiotic approved in the U.S. and only the second FDA-approved therapy for uUTIs in over 20 years.

This approval, based on pivotal Phase 3 trials (SURE 1 and REASSURE), demonstrated ORLYNVAH™’s efficacy and safety in treating uUTIs, including its superiority over standard treatments like ciprofloxacin and Augmentin™ in resistant cases. The company aims to leverage this approval to seek strategic partnerships to expand ORLYNVAH™’s market reach.

Iterum CEO Corey Fishman expressed gratitude, “We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians. As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.”

The company will host a conference call on Monday, October 28, 2024, at 8:30 a.m. ET