Welcome to our dedicated page for Iterum Therapeutics Plc news (Ticker: ITRM), a resource for investors and traders seeking the latest updates and insights on Iterum Therapeutics Plc stock.
Iterum Therapeutics Plc (ITRM) is a clinical-stage pharmaceutical company pioneering treatments for multi-drug resistant infections. This page provides investors and industry professionals with verified news and press releases about ITRM's advancements in oral and IV anti-infectives.
Access real-time updates on clinical trials, regulatory milestones like Qualified Infectious Disease Product (QIDP) designations, and strategic partnerships. Our curated repository ensures you stay informed about developments in antibiotic resistance solutions without promotional bias.
Key coverage areas include Phase 3 trial results, FDA communications, financial reporting, and R&D collaborations. All content is sourced directly from Iterum Therapeutics and reputable financial publications to ensure accuracy.
Bookmark this page for streamlined access to ITRM's latest progress in addressing global health challenges through differentiated anti-infective therapies.
Iterum Therapeutics (Nasdaq: ITRM) provided a business update on Dec. 17, 2025 focused on market access and intellectual property.
Market access: Iterum finalized a commercial contract with a GPO that works with one of the largest U.S. PBMs, adding coverage opportunities for more than 40 million lives beginning in early 2026. The company plans targeted pull-through campaigns for prescribers in high-coverage geographies in Q1 2026 and said additional Commercial and Medicare Part D agreements are pending execution.
Patent: The Japanese Patent Office issued a Decision to Grant for a patent covering a combination including sulopenem etzadroxil; the patent is projected to expire in March 2041, subject to maintenance payments.
Iterum Therapeutics (Nasdaq: ITRM) provided a business update on Dec 5, 2025 highlighting commercial access, distribution, and IP developments for ORLYNVAH™.
Key items: nearly 25% of U.S. insured lives now have coverage for ORLYNVAH™, with more than 60 million insured lives reachable via varied plan designs; a signed rebate agreement with a top‑three Medicare Part D PBM positions ORLYNVAH™ for formulary inclusion as early as Q1 2026; ORLYNVAH™ is stocked at McKesson and Cencora to support physician procurement; and the European Patent Office signaled intent to grant a patent covering a sulopenem etzadroxil/probenecid bilayer tablet with projected expiry in December 2039.
Iterum Therapeutics (Nasdaq: ITRM) provided a business update on November 24, 2025, highlighting two commercial and regulatory milestones.
Key points: ORLYNVAH is now stocked at McKesson enabling certain physicians to procure the product through that specialty distribution channel. Iterum also announced FDA 510(k) clearance of a 2 µg sulopenem antimicrobial susceptibility test disc, manufactured by Liofilchem, for Enterobacterales susceptibility testing using FDA interpretive criteria. Liofilchem received authorization in the FDA Global Unique Device Identification Database and the discs are available to order in the U.S. from Liofilchem, Inc.
Iterum Therapeutics (Nasdaq: ITRM) reported Q3 2025 results after commercially launching ORLYNVAH in the United States in August 2025 for uncomplicated urinary tract infections.
Key financials: cash and cash equivalents $11.0M at Sept 30, 2025; Iterum said cash plus $2.6M ATM proceeds through Nov 13, 2025, fund operations into Q2 2026. Q3 product revenue was $0.4M. Q3 net loss was $9.0M and non-GAAP net loss was $7.3M. Management expects 2026 net product sales of ORLYNVAH to range $5M–$15M, depending on uptake and payer coverage.
Other items: granted patents in China (expires Mar 2041) and Mexico (expires Dec 2039), and a conference call was scheduled for Nov 14, 2025 at 8:30 a.m. ET.
Iterum Therapeutics (Nasdaq: ITRM) will release its third quarter 2025 financial results before U.S. market open on Friday, November 14, 2025.
Management will host a conference call at 8:30 a.m. ET the same day to discuss results and provide a business update. Dial-in numbers are 833-470-1428 (domestic) and 404-975-4839 (international) with Access Code 459214. Investors can pre-register at https://events.q4inc.com/attendee/334189282. An audio webcast will be available after the call under Financials & Filings in the Investors section at www.iterumtx.com.
Iterum Therapeutics (Nasdaq: ITRM) will present clinical data at IDWeek 2025 in Atlanta, GA, taking place October 19–22, 2025. The company will present two posters and host a Learning Lounge on October 21, 2025 at 1:15 pm EST.
Poster details:
- P784 – "Risk factors for treatment failure in patients with uncomplicated urinary tract infection," presenter Steven I. Aronin, MD; Monday, October 20, 12:15 pm–1:30 pm, Poster Hall B4-5.
- P1208 – "In vitro activity of sulopenem and comparator agents against U.S. Enterobacterales clinical isolates, SENTRY antimicrobial surveillance program, 2023," presenter Steven I. Aronin, MD; Tuesday, October 21, 12:15 pm–1:30 pm, Poster Hall B4-5.
The Learning Lounge presentation is titled "An Overview of Urinary Tract Infection in Adult Women: Focus on Oral Sulopenem," with presenters Steven I. Aronin, MD and Michael Dunne, MD. Posters will be posted on the company's "Publications: Posters & Presentations" page under "Our Science" after the conference ends.
Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation antibiotics, provided key business updates on its recently launched drug ORLYNVAH™. The drug was launched in August 2025 across seven U.S. states in partnership with EVERSANA Life Science Services. The company is actively working on expanding market access through discussions with major pharmacy benefit managers.
Key developments include FDA 510(k) clearance for its Antimicrobial Susceptibility Test Disc, new patent grants in China and Mexico, and sufficient cash runway into 2026, supported by $2.2 million raised through its at-the-market offering program. The company will present at IDWeek 2025 in Atlanta on October 21, focusing on urinary tract infections and oral sulopenem.
Iterum Therapeutics (Nasdaq: ITRM) has launched ORLYNVAH™ (sulopenem etzadroxil and probenecid), marking a significant milestone as the first oral penem antibiotic available in the U.S. The FDA-approved treatment targets uncomplicated urinary tract infections (uUTIs) in adult women, specifically those caused by specific bacteria with limited treatment alternatives.
The launch addresses a critical medical need, as 57% of initial UTI infections show resistance to at least one antibiotic class, and 13% are resistant to three or more antibiotics. ORLYNVAH™ represents the first new branded product for uUTI treatment in over 25 years. To enhance accessibility, Iterum is offering a copay savings program allowing eligible patients to obtain ORLYNVAH™ for as little as $25.
Iterum Therapeutics (Nasdaq: ITRM) reported Q2 2025 financial results and announced the upcoming launch of ORLYNVAH™, the first branded antibiotic for uncomplicated urinary tract infections (uUTIs) in over 25 years. The company reported a net loss of $6.5 million for Q2 2025, compared to $5.0 million in Q2 2024.
Key developments include a partnership with EVERSANA for U.S. commercialization, a manufacturing agreement with ACS Dobfar S.p.A, and the appointment of Christine Coyne as Chief Commercial Officer. The company's cash position of $13.0 million, plus $2.2 million raised through ATM offering, is expected to fund operations into 2026.
ORLYNVAH™, the only FDA-approved oral penem antibiotic in the U.S., targets resistant Gram-negative bacteria, including ESBL-producing Enterobacterales. The company also secured patent protection in Canada until 2039 and had its REASSURE Phase 3 trial results published in NEJM Evidence.
Iterum Therapeutics (Nasdaq: ITRM), a developer of next-generation oral and IV antibiotics, has scheduled its second quarter 2025 financial results announcement for August 5, 2025, before U.S. markets open.
The company will host a conference call at 8:30 a.m. ET on the same day, where management will discuss financial results and provide a business update. Investors can access the call via phone using the numbers 833-470-1428 (domestic) or 404-975-4839 (international) with Access Code 740801. A webcast will be available on the company's investor relations website.
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