Iterum Therapeutics Provides Business Update

Rhea-AI Summary

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.

Positive

• PBM/GPO contract covers >40 million lives starting early 2026
• Planned Q1 2026 pull-through campaigns for prescribers
• Japanese patent decision to grant with projected March 2041 expiry

Negative

• Remaining Commercial and Medicare Part D agreements are pending execution
• Patient access depends on phased rollout beginning early 2026
• Patent term contingent on timely payment of maintenance fees

Key Figures

Lives with coverage opportunity more than 40 million lives Coverage via major PBM-related Group Purchasing Organization starting early 2026

Launch timing Q1 2026 Targeted pull-through campaigns in high-coverage geographies

Patent application number 2022-554381 Japanese patent application for sulopenem etzadroxil, probenecid, valproic acid combo

Japanese patent expiry March 2041 Projected expiration of Japanese patent, absent extensions and with fee payments

Market Reality Check

$0.4020 Last Close

Volume Volume 375,443 is 0.37x the 20-day average of 1,019,930, indicating subdued trading ahead of this update. low

Technical Price at $0.402 is trading below the 200-day MA of $0.87 and sits 80.86% under the 52-week high.

Peers on Argus

ITRM was down 4.51% while peers showed mixed moves: OKUR down 4.13%, TENX up 5.18%, RVPH up 1.22%, others flat. This points to a stock-specific setup rather than a broad biotech move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 05	Business update	Positive	+4.8%	Expanded ORLYNVAH coverage, distribution, and European patent progress.
Nov 24	Business update	Positive	+8.8%	McKesson stocking and FDA 510(k) clearance for sulopenem test disc.
Nov 14	Earnings release	Negative	-16.1%	Q3 loss, modest revenue, and limited cash runway guidance.
Nov 07	Earnings date notice	Neutral	+3.8%	Announcement of Q3 results release and conference call timing.
Oct 14	Conference participation	Neutral	+0.0%	Planned data presentations and UTI-focused learning session at IDWeek.

Pattern Detected

Recent news—especially ORLYNVAH access and commercialization updates—has typically seen price moves aligning with the generally positive tone, while earnings with liquidity concerns aligned with negative reactions.

Recent Company History

Over the last few months, Iterum has focused on ORLYNVAH™ commercialization and intellectual property. Business updates on Nov 24 and Dec 5, 2025 highlighted distribution, payer access, and European patent progress, with positive price reactions of 8.75% and 4.84%. The Q3 2025 results on Nov 14 showed modest early revenue and notable losses, driving a -16.11% move. Conference and earnings-date announcements had muted to modest impacts. Today’s update extends that trajectory with further U.S. payer expansion and Japanese patent protection.

Market Pulse Summary

This announcement added two pillars to Iterum’s story: expanded U.S. market access for ORLYNVAH™ via a major PBM-related contract affecting over 40 million covered lives from early 2026, and a Japanese patent on a sulopenem-based combination projected to last until March 2041. In context of recent filings noting losses and liquidity pressure, investors may focus on how faster payer uptake, execution of pending Commercial and Medicare Part D deals, and IP fortification translate into sustainable revenue growth.

Key Terms

pharmacy benefit managers financial

"one of the largest Pharmacy Benefit Managers (“PBMs”) in the United States"

Pharmacy benefit managers are companies that manage prescription drug plans for health insurers, employers, and other organizations. They negotiate prices with drug manufacturers, decide which medications are covered, and handle the distribution of prescriptions. Their role can impact healthcare costs and drug availability, making them an important factor for investors to consider in the healthcare and pharmaceutical industries.

group purchasing organization financial

"a commercial contract with a Group Purchasing Organization that collaborates"

A group purchasing organization (GPO) is an entity that helps a group of buyers, such as healthcare providers or businesses, combine their purchasing power to buy goods or services at lower prices. By negotiating on behalf of its members, a GPO can secure better deals than individual buyers could on their own. This can lead to cost savings and operational efficiencies, making GPOs important players in industries where large-scale purchasing influences overall expenses and profitability.

medicare part d regulatory

"approval of additional Commercial and Medicare Part D agreements currently pending"

Medicare Part D is the U.S. federal program that helps people on Medicare pay for outpatient prescription drugs through private plans that negotiate prices and list covered medicines. For investors it matters because the program shapes how drugs are priced, which medicines get chosen by plans, and how much patients and insurers pay—similar to a large group discount card that influences sales, margins, and revenue predictability across drugmakers, insurers, pharmacies and pharmacy benefit managers.

probenecid medical

"cover a combination of sulopenem etzadroxil, probenecid, and valproic acid"

Probenecid is an older prescription drug that helps the body shed excess uric acid by encouraging the kidneys to flush more of it into the urine, and it can also slow the kidneys’ removal of other drugs so those drugs stay in the bloodstream longer. Investors should watch probenecid because changes in its approved uses, safety profile, supply, or use as an add‑on to boost other medicines can affect sales, regulatory reviews, and clinical trial strategies for treatments that rely on it.

AI-generated analysis. Not financial advice.

DUBLIN and CHICAGO, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum” or “we”), 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 business update.

Recent Events

• Market Access Update:
  
  • Payor Reimbursement and Contracting Expands with Major PBM Agreement: ORLYNVAH™’s market access continues to accelerate. We have finalized a commercial contract with a Group Purchasing Organization that collaborates with manufacturers on behalf of one of the largest Pharmacy Benefit Managers (“PBMs”) in the United States, adding coverage opportunities for more than 40 million lives starting in early 2026. This milestone underscores ORLYNVAH™’s growing acceptance across the payor landscape.
    
  • Beginning in Q1 2026, Iterum plans to launch targeted pull-through campaigns focused on prescribers in high-coverage geographies, while we await approval of additional Commercial and Medicare Part D agreements currently pending execution. This latest partnership significantly broadens patient access, and we remain optimistic that remaining payors will adopt terms across Commercial, Part D, and Government segments.
    
• Expansion of Patent Estate: The Japanese Patent Office has issued a Decision to Grant in Japanese Patent Application No. 2022-554381, entitled “Combinations of Beta-Lactam Compounds, Probenecid, and Valproic Acid and Uses Thereof”. The allowed claims cover a combination of sulopenem etzadroxil, probenecid, and valproic acid for treating specified diseases. Upon issuance, this Japanese Patent will be projected to expire in March 2041, absent any extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent.
  

About Iterum Therapeutics plc

Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its New Drug Application (NDA) for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the FDA and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.

About ORLYNVAH™

ORLYNVAH™ (oral sulopenem) is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode ESBL or AmpC-type ß-lactamases that confer resistance to third generation cephalosporins.

Cautionary Note Regarding Forward-looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding Iterum’s plans, strategies and prospects for its business, including Iterum’s ability to secure Medicare Part D and additional commercial coverage in Q1 2026 and the development, therapeutic and market potential of ORLYNVAH™. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum’s control, including risks and uncertainties concerning Iterum’s ability to raise sufficient capital and successfully implement its commercialization plans for ORLYNVAH™ with its commercial sales organization partners, Iterum’s ability to expand and maintain a sales force, the protection provided by Iterum’s patents, the ability of shareholders and other stakeholders to realize any value or recovery as part of a wind down process if Iterum is unsuccessful at implementing its commercialization of ORLYNVAH™, the market opportunity for and the potential market acceptance of ORLYNVAH™ for uUTIs caused by certain designated microorganisms in adult women who have limited or no alternative oral antibacterial treatment options, uptake of ORLYNVAH™ by physicians and payer coverage, existing or new competition for ORLYNVAH™, Iterum’s ability to continue as a going concern, uncertainties inherent in the conduct of clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, changes in public policy or legislation, commercialization plans and timelines, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum’s expectations regarding how far into the future Iterum’s cash on hand will fund Iterum’s ongoing operations, Iterum’s ability to maintain its listing on the Nasdaq Capital Market and other factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q filed with the SEC on November 14, 2025, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum’s beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Investor Contact:
Judy Matthews
Chief Financial Officer 312-778-6073
IR@iterumtx.com

FAQ

What did Iterum (ITRM) announce about PBM coverage on Dec. 17, 2025?

Iterum announced a GPO contract tied to one of the largest U.S. PBMs that adds coverage opportunities for more than 40 million lives beginning in early 2026.

When will Iterum (ITRM) begin prescriber pull-through campaigns for ORLYNVAH?

Iterum plans targeted pull-through campaigns in Q1 2026 focused on prescribers in high-coverage geographies.

Are Iterum's Commercial and Medicare Part D agreements finalized for ORLYNVAH (ITRM)?

No; the company said additional Commercial and Medicare Part D agreements are currently pending execution.

What patent news did Iterum (ITRM) disclose on Dec. 17, 2025?

The Japanese Patent Office issued a Decision to Grant for a patent covering a combination including sulopenem etzadroxil, with projected expiry in March 2041.

How will the new PBM/GPO agreement affect patient access to ORLYNVAH (ITRM)?

The agreement broadens access by adding coverage opportunities for >40 million lives starting in early 2026, supporting wider patient reach.

Does the granted Japanese patent for Iterum (ITRM) have any conditions or limits?

Yes; the patent's projected March 2041 expiry is subject to timely payment of maintenance fees and absent extensions.