Iterum Therapeutics Provides Business Update
Rhea-AI Summary
Iterum Therapeutics (Nasdaq: ITRM) announced expanded market access and patent protection for ORLYNVAH and FDA feedback on a step-down use. A Medicare Part D rebate deal adds coverage for >3.5 million lives beginning as early as this quarter. A U.S. patent (No. 12,544,337) was granted, projected to expire December 2039. The FDA stated an sNDA with substantial evidence from an adequate clinical trial is needed to support ORLYNVAH as step-down therapy for complicated UTI and recommended a Type C meeting to discuss trial design and endpoints.
Positive
- Medicare Part D coverage expected to reach >3.5 million lives this quarter
- U.S. patent granted on sulopenem etzadroxil/probenecid bilayer tablet, expiring Dec 2039
Negative
- FDA requires an adequate, well-designed clinical trial and sNDA to support step-down indication
Market Reaction
Following this news, ITRM has declined 6.96%, reflecting a notable negative market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.27. This price movement has removed approximately $1M from the company's valuation. Trading volume is above average at 1.7x the average, suggesting increased trading activity.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Key Figures
Market Reality Check
Peers on Argus
ITRM fell 2.44% while peers ANTX, OKUR, KZR, TENX and RVPH also showed negative moves, but no peers appeared in momentum scans and no same-day peer news was flagged, pointing to a stock-specific reaction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 23 | Business update | Positive | -4.5% | Expanded ORLYNVAH access and FDA engagement on step-down therapy claim. |
| Dec 17 | Business update | Positive | -3.2% | Large GPO contract expanding commercial coverage and new Japanese patent. |
| Dec 05 | Business update | Positive | +4.8% | Broader U.S. coverage, distribution stocking, and European patent progress. |
| Nov 24 | Business update | Positive | +8.8% | ORLYNVAH stocking at McKesson and 510(k) clearance for test disc. |
| Nov 14 | Earnings report | Negative | -16.1% | Q3 2025 loss, modest launch revenue, going‑concern and liquidity pressures. |
Business updates have often been positive on fundamentals but produced mixed price reactions, with several prior access/IP updates selling off despite constructive news.
Over the past few months, Iterum has repeatedly updated investors on ORLYNVAH™ commercialization and intellectual property. Prior updates in Nov–Dec 2025 highlighted stocking at McKesson, expanded U.S. coverage reaching tens of millions of lives, and new patents with expiry dates out to Dec 2039 and Mar 2041. Despite these milestones, shares sometimes declined after seemingly positive updates. The latest announcement continues this theme: expanded Medicare Part D access, another Orange Book–listable U.S. patent projected to expire in Dec 2039, and FDA feedback on requirements for a step‑down cUTI indication.
Market Pulse Summary
The stock is down -7.0% following this news. A negative reaction despite operational progress would fit a pattern where Iterum’s constructive business updates sometimes coincided with selling pressure. The latest news adds coverage and patent depth but also clarifies that a well-designed clinical trial is required for a step‑down cUTI claim. In that context, traders might focus on development costs and prior disclosures about liquidity and listing compliance, which could magnify downside when sentiment weakens.
Key Terms
medicare part d regulatory
pharmacy benefit managers financial
orange book regulatory
snda regulatory
step-down therapy medical
AI-generated analysis. Not financial advice.
--Expanded Market Access and Patent Protection for ORLYNVAH™
--FDA correspondence regarding the use of ORLYNVAH™ as step-down therapy
DUBLIN and CHICAGO, Feb. 13, 2026 (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:
- Medicare Part D Milestone: We are pleased to announce another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, in addition to our existing agreements with the other two of the top three. This agreement positions ORLYNVAH™ for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage of more than 3.5 million lives expected to begin as early as this quarter.
- Medicare Part D Milestone: We are pleased to announce another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, in addition to our existing agreements with the other two of the top three. This agreement positions ORLYNVAH™ for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage of more than 3.5 million lives expected to begin as early as this quarter.
- Patent Portfolio: Iterum has been granted a patent in the United States as patent number 12,544,337, entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof”, that covers a bilayer tablet comprising sulopenem etzadroxil and probenecid, a method of making the bilayer tablet, and methods of treating diseases, including uncomplicated urinary tract infection. This US patent is projected to expire in December 2039, absent any patent term extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent. This patent is Orange Book listable, and if added, will total five U.S. patents listed in the FDA’s Orange Book.
- FDA: The US Food and Drug Administration (“FDA”) has responded to Iterum’s request to discuss the use of ORLYNVAH™ as step-down therapy and the collection of real world data to support the proposed claim. The FDA has determined that Iterum would need to provide substantial evidence of effectiveness from an adequate and well-designed clinical trial in a supplemental new drug application (sNDA) to support the proposed indication for ORLYNVAH™ as step-down treatment of complicated urinary tract infections (cUTI). The FDA recommends that Iterum request a Type C meeting to discuss the design and endpoints of any proposed clinical investigation to support the proposed indication.
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 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 Medicare Part D coverage did Iterum (ITRM) secure for ORLYNVAH and when does it start?
What does Iterum's new U.S. patent (No. 12,544,337) cover and when does it expire for ITRM?
What did the FDA tell Iterum about using ORLYNVAH as step-down therapy for cUTI (ITRM)?
How should investors view the impact of the Medicare Part D agreement on Iterum (ITRM) near term?
What are Iterum's next regulatory steps after FDA feedback on ORLYNVAH for ITRM?
