Iterum Therapeutics Plc Stock Price, News & Analysis

Iterum Therapeutics plc (Nasdaq: ITRM) is a pharmaceutical company focused on anti-infective therapies that address infections caused by multi-drug resistant pathogens in both community and hospital settings. According to the company’s disclosures, Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective available in oral and intravenous (IV) formulations. The company’s activities are centered on the development and commercialization of antibiotics for serious and difficult-to-treat bacterial infections.

Iterum operates in the pharmaceutical preparation manufacturing industry within the broader manufacturing sector. Its primary focus is on differentiated anti-infectives intended to combat the global challenge of antimicrobial resistance. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria that are resistant to other antibiotics, as described in multiple company press releases.

ORLYNVAH™ (oral sulopenem)

A central element of Iterum’s business is ORLYNVAH™ (oral sulopenem), described by the company as a novel oral penem antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs). ORLYNVAH™ is approved by the U.S. Food and Drug Administration (FDA) for adult women with uUTIs caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis who have limited or no alternative oral antibacterial treatment options. Company materials state that ORLYNVAH™ is commercially available in the United States.

Iterum notes that ORLYNVAH™ possesses potent activity against species of Enterobacterales, including those that encode extended spectrum beta-lactamases (ESBL) or AmpC-type β-lactamases that confer resistance to third generation cephalosporins. This positions ORLYNVAH™ within a subset of antibiotics aimed at resistant gram-negative pathogens. In company communications, ORLYNVAH™ is also referred to as the first oral penem antibiotic commercially available in the U.S. and a new branded product option in the uUTI space.

Sulopenem IV and Oral Development

Beyond the approved oral product, Iterum describes its broader program as the development of sulopenem in both oral and IV formulations. The company highlights that sulopenem has demonstrated in vitro activity against a wide range of bacteria, including gram-negative, gram-positive and anaerobic organisms that are resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for its oral and IV formulations of sulopenem in seven indications, according to repeated disclosures in its press releases.

Iterum’s communications emphasize the goal of addressing serious and life-threatening diseases around the world by developing differentiated anti-infectives. The company’s efforts include clinical development, regulatory interactions and commercialization planning around sulopenem-based products.

Regulatory and Commercial Milestones

Company press releases and SEC filings describe several key regulatory and commercial milestones:

• FDA approval of ORLYNVAH™ (oral sulopenem) for treatment of uUTIs in adult women with limited or no alternative oral antibacterial options.
• Commercial launch of ORLYNVAH™ in the United States into the community market, with activities carried out in partnership with EVERSANA Life Science Services, LLC, which provides sales and commercial operations services, as well as marketing, logistics, channel management, regulatory, medical affairs and other commercialization-related services.
• Market access initiatives involving engagement with major pharmacy benefit managers (PBMs), Medicare Part D PBMs, state Medicaid programs, and other health plans to expand reimbursement and formulary coverage for ORLYNVAH™.
• Specialty distribution arrangements under which ORLYNVAH™ is stocked at distributors such as McKesson and Cencora (formerly AmerisourceBergen), enabling certain physicians to procure the product through these channels.
• FDA 510(k) clearance for a 2 µg antimicrobial susceptibility test disc for sulopenem, intended for use in microbiology laboratories for susceptibility testing of Enterobacterales by the disc diffusion method, using FDA Susceptibility Test Interpretive Criteria.

Intellectual Property and Patent Estate

Iterum reports ongoing efforts to expand and protect its patent estate around sulopenem and related combinations. Company announcements describe patents granted or projected in multiple jurisdictions, including:

• A Chinese patent covering combinations of sulopenem etzadroxil, probenecid and valproic acid for treating specified diseases, with a projected expiry in March 2041, absent extensions and assuming timely maintenance fee payments.
• A Mexican patent covering a bilayer tablet comprising sulopenem etzadroxil and probenecid, methods of preparing the bilayer tablet, and its use in treating specified diseases, with a projected expiry in December 2039, subject to similar conditions.
• A European patent application for combinations of beta-lactam compounds and probenecid, including a bilayer tablet of sulopenem etzadroxil and probenecid, for which the European Patent Office has indicated an intention to grant a patent, with projected expiry in December 2039, absent extensions and assuming maintenance fees are paid.
• A Canadian patent covering combinations of sulopenem etzadroxil and probenecid in treating multiple diseases, including uUTIs, with a projected expiry in December 2039, assuming no extensions and timely maintenance fee payments.
• A Japanese patent application covering combinations of sulopenem etzadroxil, probenecid and valproic acid for treating specified diseases, for which the Japanese Patent Office has issued a decision to grant, with projected expiry in March 2041 under similar assumptions.

The company states that it continues to optimize its patent strategy by prioritizing key jurisdictions and expanding its patent portfolio related to sulopenem formulations and combinations.

Scientific and Medical Engagement

Iterum participates in scientific and medical forums to present data on sulopenem and uUTIs. Company news highlights include:

• Presentation of posters at the Infectious Disease Society of America’s IDWeek conference, including data on risk factors for treatment failure in patients with uncomplicated urinary tract infection and in vitro activity of sulopenem and comparator agents against U.S. Enterobacterales clinical isolates.
• A Learning Lounge session at IDWeek titled “An Overview of Urinary Tract Infection in Adult Women: Focus on Oral Sulopenem.”
• Publication of results from the REASSURE Phase 3 clinical trial in NEJM Evidence, comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral amoxicillin/clavulanate in adult women with uUTIs, as referenced in company communications.

Capital Markets and Listing Status

Iterum’s ordinary shares trade on The Nasdaq Stock Market LLC under the symbol ITRM. SEC filings indicate that the company has used an at-the-market (ATM) offering program under a registration statement on Form S-3 to issue and sell ordinary shares through a sales agent. A prospectus supplement filed in connection with this program relates to additional potential gross proceeds up to a specified amount, subject to share limits.

In 2025, Iterum received Nasdaq notices of non-compliance with certain continued listing standards. An August 25, 2025 notice indicated that the company was not in compliance with Nasdaq Listing Rule 5550(a)(2) regarding the minimum bid price of $1.00 per share, and provided a 180-day period to regain compliance, with the possibility of an additional period subject to conditions. A December 11, 2025 notice indicated non-compliance with Nasdaq Listing Rule 5550(b)(2) regarding a minimum market value of listed securities of $35 million, and provided a 180-day compliance period. The company’s filings state that these notices do not result in immediate delisting and outline potential appeal and remediation paths. As of the dates of the filings, Iterum’s securities remained listed on The Nasdaq Capital Market.

Corporate Governance and Shareholder Matters

Iterum’s SEC filings describe standard corporate governance and shareholder matters, including annual general meetings, election of directors, ratification of the independent registered public accounting firm, advisory votes on executive compensation, and proposals related to authorized share capital, directors’ allotment authority, pre-emption rights and equity incentive plans. Voting outcomes for these proposals are detailed in the company’s Form 8-K filings.

Business Focus and Segment

According to its descriptions, Iterum operates through a single business segment focused on the development and commercialization of treatments for drug-resistant bacterial infections. The company’s stated mission is to deliver differentiated anti-infectives to significantly improve the lives of people affected by serious and life-threatening diseases, with an emphasis on addressing the global crisis of multi-drug resistant pathogens.

Key Risks and Forward-Looking Considerations

Iterum’s press releases and SEC filings include extensive forward-looking statements and risk factor references. These cover topics such as the company’s ability to raise capital, implement commercialization plans for ORLYNVAH™, maintain its Nasdaq listing, secure payer coverage and formulary positioning, and manage clinical, regulatory and operational uncertainties. Investors are directed in those documents to the “Risk Factors” sections of the company’s periodic SEC reports for more detail.