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DUBLIN/CHICAGO - Iterum Therapeutics plc (NASDAQ:ITRM), a micro-cap biotech company with a market capitalization of $30.35 million, has begun commercializing its newly approved antibiotic ORLYNVAH in select territories across seven U.S. states, according to a company statement released Friday. According to InvestingPro data, the stock has experienced significant volatility, declining over 53% in the past six months.
The oral antibiotic, which received FDA approval for treating urinary tract infections caused by specific bacteria in adult women with limited treatment options, was launched in August 2025 in partnership with EVERSANA Life Science Services.
Iterum reported that sales representatives are actively engaging with target physicians, resulting in initial prescriptions being written. The company has also received inquiries from non-targeted physicians interested in the medication.
The company’s national account managers are working to secure formulary coverage with major health plans and pharmacy benefit managers. ORLYNVAH is currently accessible through prior authorization and medical exception pathways, with expanded access expected by early 2026.
In a regulatory milestone, Iterum received FDA 510(k) clearance for its antimicrobial susceptibility test disc, which will allow microbiology labs to determine bacterial sensitivity to the antibiotic.
The company stated that its current cash position, including $2.2 million raised through its at-the-market offering program between July and August 2025, should fund operations into 2026. InvestingPro analysis reveals a concerning financial health score of 1.69 (labeled as WEAK), though the company maintains a healthy current ratio of 2.69, indicating sufficient liquid assets to meet short-term obligations. For deeper insights into Iterum’s financial position and 8 additional key ProTips, subscribers can access the comprehensive Pro Research Report.
Iterum also announced patent approvals in China and Mexico for combinations involving sulopenem etzadroxil, the active ingredient in ORLYNVAH. The Chinese patent, covering a combination with probenecid and valproic acid, extends to 2041, while the Mexican patent for a bilayer tablet formulation extends to 2039.
The company will present on urinary tract infections with a focus on oral sulopenem at IDWeek 2025 in Atlanta on October 21. With a beta of 3.04, investors should note that ITRM exhibits significantly higher volatility than the broader market. Discover more detailed analysis and valuable insights about Iterum Therapeutics and 1,400+ other stocks through InvestingPro’s comprehensive research reports.
ORLYNVAH is described as a novel oral penem antibiotic with activity against certain antibiotic-resistant bacteria, including those that produce enzymes conferring resistance to commonly used antibiotics.
In other recent news, Iterum Therapeutics announced its second-quarter 2025 earnings, reporting an earnings per share (EPS) of -$0.13. This result slightly missed the analysts’ forecast of -$0.11. The company also shared updates on its new product launch and strategic plans designed to enhance its standing in the urinary tract infection market. These developments are part of Iterum’s ongoing efforts to strengthen its competitive edge. The company’s recent earnings report has been a focal point for investors, given its implications for future financial performance. While the stock saw a dip in pre-market trading, analysts continue to monitor Iterum’s strategic initiatives closely. The emphasis remains on how these efforts will impact the company’s market position and financial health moving forward.
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