DUBLIN and CHICAGO, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today provided a general business update. ORLYNVAHTM Launch Update In partnership with EVERSANA Life Science Services, LLC (“EVERSANA”), ORLYNVAH™ was launched in August 2025 into the community market in the U.S. in targeted territori ...

Core Viewpoint - Iterum Therapeutics has launched ORLYNVAH™, the first oral penem antibiotic in the U.S. for treating uncomplicated urinary tract infections (uUTIs) in women, addressing a significant unmet medical need in the face of rising antibiotic resistance [1][5]. Group 1: Product Launch and Approval - ORLYNVAH™ (sulopenem etzadroxil and probenecid) received FDA approval in October 2024 for adult women with uUTIs caused by specific pathogens [1][5]. - This product is the first new branded treatment for uUTIs in over 25 years, providing a critical option for patients with limited oral antibacterial alternatives [1][5]. Group 2: Market Need and Impact - Approximately 60% of women experience a urinary tract infection in their lifetime, with 44% having three or more episodes annually, highlighting the prevalence of this condition [2]. - The increasing resistance to antibiotics is expected to inflate healthcare costs and lead to poor patient outcomes, emphasizing the urgent need for new therapies [2]. Group 3: Clinical and Patient Benefits - Clinicians have expressed that ORLYNVAH™ offers impressive efficacy data and a much-needed treatment option for women suffering from difficult-to-treat uUTIs [3]. - The introduction of ORLYNVAH™ is anticipated to reduce emergency department visits and hospital admissions, positively impacting patients' quality of life [3]. Group 4: Company Mission and Future Plans - Iterum Therapeutics aims to address the global crisis of multi-drug-resistant pathogens by developing differentiated anti-infectives [5]. - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its formulations, indicating a strong commitment to innovation in this therapeutic area [5].

Highlights From the Quarter: Financial and Operational Developments The company reported no revenue in the quarter, which matches its pre-launch status and analyst forecasts. Non-GAAP EPS was a loss of $0.13, steeper than the anticipated $0.11 non-GAAP loss, largely due to a substantial increase in general and administrative (G&A) spending. This rise in G&A costs—from $1.9 million in the prior-year quarter to $4.2 million (GAAP)—was linked to investments in pre-commercialization work, such as market researc ...

-- Launch of ORLYNVAH Expected August 2025— --Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN and CHICAGO, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the second quarter ended June 30, 2025. "We are on track to launch ORLYNVAH™ this m ...

Company Overview - Iterum Therapeutics plc focuses on delivering next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings [1][3] - The company is advancing the development of its first compound, sulopenem, which is a novel penem anti-infective compound with both oral and IV formulations [3] Financial Results Announcement - The company will release its second quarter 2025 financial results before the U.S. financial markets open on August 5, 2025 [1] - A conference call will be hosted by management at 8:30 a.m. ET on the same day to discuss the financial results and provide a business update [1] Product Development and Approvals - Sulopenem has shown potent in vitro activity against a variety of gram-negative, gram-positive, and anaerobic bacteria resistant to other antibiotics [3] - The company has received approval for its NDA for ORLYNVAH™ (oral sulopenem) for treating uncomplicated urinary tract infections caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [3] - Iterum has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [3]

Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][3] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [3] Recent Developments - Iterum has granted a non-statutory share option to purchase 200,000 ordinary shares to Christine Coyne, the newly appointed Chief Commercial Officer [1][2] - The share option has an exercise price of $0.97 per share, equal to the closing price on the date of grant, and vests over four years [2] Product Information - ORLYNVAH™ is a novel oral penem antibiotic developed by Iterum for the treatment of uncomplicated urinary tract infections (uUTIs) [3][4] - ORLYNVAH™ is effective against Enterobacterales species that are resistant to third-generation cephalosporins due to extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases [4]

Company Overview - Iterum Therapeutics plc is focused on delivering next-generation oral and IV antibiotics to combat infections caused by multi-drug resistant pathogens [1][4] - The company is advancing the development of its first compound, sulopenem, which has shown potent in vitro activity against various resistant bacteria [4] Leadership Appointment - Christine Coyne has been appointed as the Chief Commercial Officer, a newly created position, to lead all commercial efforts for Iterum [1][2] - Coyne brings over 30 years of experience in the pharmaceutical industry, with a strong background in anti-infectives [2][3] Product Launch - The upcoming launch of ORLYNVAH™, an oral formulation of sulopenem, is a significant opportunity for the company to address unmet medical needs in treating uncomplicated urinary tract infections (uUTIs) [1][3][5] - ORLYNVAH™ has received FDA approval for the treatment of uUTIs caused by specific microorganisms in adult women with limited or no alternative oral antibacterial treatment options [4][5] Market Positioning - The company aims to accelerate launch readiness for ORLYNVAH™ and scale its capabilities for long-term growth [2][3] - ORLYNVAH™ is designed to be effective against Enterobacterales species that are resistant to third-generation cephalosporins [5]

Core Insights - Iterum Therapeutics has reported the publication of results from its Phase 3 REASSURE trial, demonstrating the efficacy of oral sulopenem compared to Augmentin for treating uncomplicated urinary tract infections (uUTIs) in women [1][2] - The trial showed that oral sulopenem was statistically superior to Augmentin, with an overall success rate of 61.7% compared to 55.0% for Augmentin [4] - The FDA has approved ORLYNVAH™, Iterum's new drug for treating uUTIs caused by specific resistant pathogens, based on robust data from the REASSURE trial and another pivotal study [5][6] Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][9] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [9] Clinical Trial Details - The REASSURE trial was a non-inferiority study designed to compare oral sulopenem with Augmentin in a population of adult women with uncomplicated uUTIs [2][4] - The trial enrolled 2,222 patients and was conducted under a Special Protocol Assessment (SPA) agreement with the FDA [2] Market Context - UTIs are among the most common bacterial infections, with approximately 15 million emergency room visits and over 40 million prescriptions for uUTIs annually in the U.S. [7] - The increasing rates of multi-drug resistance have made the treatment of uUTIs more challenging, with about 30% of uUTIs caused by quinolone non-susceptible pathogens [7]

Core Viewpoint - Iterum Therapeutics has entered into a Product Commercialization Agreement with EVERSANA to bring its oral antibiotic ORLYNVAH to the U.S. market by Q4 2025, targeting uncomplicated urinary tract infections (uUTIs) caused by multi-drug resistant pathogens [1][2]. Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat infections from multi-drug resistant pathogens in both community and hospital settings [1][5]. - The company has received FDA approval for ORLYNVAH (oral sulopenem) for treating uUTIs in adult women with limited or no alternative oral antibacterial treatment options [5][7]. Product Details - ORLYNVAH is a novel oral penem antibiotic effective against Enterobacterales species, including those resistant to third-generation cephalosporins [7]. - The treatment addresses a significant market need, as approximately 30% of uUTIs in the U.S. are caused by quinolone non-susceptible pathogens, and about 1% are resistant to all commonly available oral antibiotics [4]. Market Context - UTIs are among the most common bacterial infections, with around 15 million emergency room visits and over 40 million total prescriptions for uUTIs annually in the U.S. [4]. - Approximately two-thirds of uUTI prescriptions are for patients at elevated risk for treatment failure, highlighting the need for effective new treatments [4]. Partnership with EVERSANA - The partnership with EVERSANA aims to leverage their extensive commercial capabilities to ensure a swift market entry for ORLYNVAH [2][8]. - EVERSANA will provide a range of services including sales, marketing, logistics, and regulatory support for the commercialization of ORLYNVAH in the U.S. [1][2].

--Preparing for Potential Launch of ORLYNVAH by Q4 2025-- --Extended Cash Runway into 2026-- --Company to host conference call today at 8:30amET-- DUBLIN, Ireland and CHICAGO, May 13, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the first quarter ended March 31, 2025. "Based on pr ...