Iterum Therapeutics Provides Business Update

Rhea-AI Summary

Iterum Therapeutics (Nasdaq: ITRM) provided a business update highlighting expanded market access for ORLYNVAH™ and regulatory engagement with the FDA.

Key points: a new commercial contract tied to a major PBM adds coverage opportunities for more than 24 million lives starting early 2026; a second signed rebate agreement with a top-three Medicare Part D PBM positions ORLYNVAH™ for formulary inclusion covering more than 10 million lives as early as Q1 2026; the company requested an FDA meeting about a step-down therapy claim and the FDA set a January 24, 2026 goal date to provide written responses.

Positive

• 24M+ lives coverage opportunity via new PBM-linked contract starting early 2026
• 10M+ lives expected Medicare Part D formulary coverage as early as Q1 2026
• FDA written response date set for January 24, 2026 on step-down therapy questions

Negative

• Final top-three PBM commercial contract remains pending (expected Q1 2026)
• FDA declined a meeting; responses will be provided in written form rather than interactive review

Key Figures

New commercial coverage more than 24 million lives Coverage via Group Purchasing Organization/PBM starting early 2026

Medicare coverage more than 10 million lives Expected Medicare Advantage and Part D coverage as early as Q1 2026

FDA response goal date January 24, 2026 Goal date for FDA written responses on step-down therapy claim

Top three PBMs (commercial) final contract expected Q1 2026 Company expects final top-three PBM commercial contract in Q1 2026

Top three PBMs (Medicare Part D) two agreements signed Two of top three Medicare Part D PBMs under rebate agreements

Market Reality Check

$0.2881 Last Close

Volume Volume 936,914 is 1.39x the 20-day average of 676,125 shares ahead of this update. normal

Technical Shares at $0.3572 were trading below the $0.85 200-day moving average and near the 52-week low of $0.354.

Peers on Argus

ITRM was down 3.46% pre-news while peers showed a mixed tape: ANTX +2.78%, OKUR +1.37%, KZR +1.76%, TENX -5.68%, RVPH -4.07%, suggesting stock-specific dynamics rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 17	Business update	Positive	-3.2%	Expanded market access and IP update without immediate supportive price reaction.
Dec 05	Business update	Positive	+4.8%	Commercial access gains, Medicare Part D rebate and patent progress for ORLYNVAH.
Nov 24	Business update	Positive	+8.8%	McKesson stocking and FDA 510(k) clearance for sulopenem susceptibility test disc.
Nov 14	Earnings report	Negative	-16.1%	Q3 2025 loss, limited cash and going-concern style liquidity pressures alongside early sales.
Nov 07	Earnings date notice	Neutral	+3.8%	Scheduling of Q3 2025 results release and business update conference call.

Pattern Detected

Recent news reactions skew mostly aligned with sentiment: four aligned moves versus one divergence, with commercial and regulatory milestones often coinciding with notable price swings.

Recent Company History

Over the last few months, Iterum has repeatedly updated investors on ORLYNVAH™ commercialization and IP, alongside early financials. Business updates on Dec 5 and Nov 24 highlighted expanding U.S. coverage, distribution and patent progress, and saw positive reactions. The Nov 14 Q3 2025 report showed modest initial revenue but sizeable losses and liquidity pressure, coinciding with a double-digit decline. The current business update continues the theme of expanding market access and FDA interactions within this commercialization ramp.

Market Pulse Summary

This announcement highlights continued progress in ORLYNVAH™ market access, with new commercial coverage for more than 24 million lives and Medicare Part D positioning that could reach over 10 million lives in early 2026. It also sets a goal date of January 24, 2026 for FDA feedback on a potential step‑down therapy claim supported by real‑world data. Against prior disclosures of financial strain and listing challenges, investors may watch execution on coverage pull‑through and upcoming regulatory correspondence.

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.

medicare part d regulatory

"another signed rebate agreement with one of the top three Medicare Part D"

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.

medicare advantage prescription drug regulatory

"for inclusion on their Medicare Advantage Prescription Drug and Medicare"

A Medicare Advantage prescription drug plan is a privately run health insurance plan that bundles traditional Medicare benefits with outpatient prescription drug coverage into a single package sold to eligible seniors. For investors, these plans are revenue-generating products for insurers and drug managers; enrollment levels, drug cost trends, and regulatory changes can affect profits the way customer demand and raw material prices affect a retailer’s bottom line.

formulary regulatory

"for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies"

A formulary is a list of prescription drugs that a health insurer, hospital system, or government program has approved for coverage and payment. Think of it like an approved menu or shopping list that determines which medicines patients can get with financial help. For investors, formulary placement affects a drug maker’s potential sales, pricing power and market access, so being included—or excluded—can materially change a company’s revenue outlook.

u.s. food & drug administration regulatory

"requested a meeting from the U.S. Food & Drug Administration (“FDA”) to discuss"

The U.S. Food & Drug Administration (FDA) is the federal agency that reviews and approves medicines, medical devices, vaccines, food safety measures and related health products for use in the United States. Investors watch FDA decisions because approvals, rejections or safety warnings can quickly change a company’s sales prospects and stock value—similar to a referee’s call that can determine whether a product can legally enter the market and compete.

real-world data technical

"and the collection of real-world data to support the proposed claim"

Real-world data consists of information collected from everyday sources outside of controlled experiments or official reports, such as patient records, insurance claims, or wearable device readings. For investors, it provides a more complete picture of how products and services perform in actual use, helping them make better-informed decisions based on how things work in real life rather than just in theory or controlled settings.

step-down therapy medical

"to discuss a claim for the use of ORLYNVAHTM as step-down therapy"

Step-down therapy is the practice of moving a patient from a higher-intensity treatment or setting to a less intensive one—for example switching from intravenous drugs in a hospital to oral medication at home, or from ICU to a regular ward. For investors, it matters because it affects healthcare costs, hospital bed use, medication formats and follow-up care demand; products or services that enable safe step-downs can shorten stays, reduce bills and shift revenue from inpatient to outpatient channels.

AI-generated analysis. Not financial advice.

Expanded Market Access for ORLYNVAHTM

DUBLIN and CHICAGO, Dec. 23, 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 another 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 24 million lives starting in early 2026. This milestone underscores ORLYNVAH™’s growing acceptance across the payor landscape. The Company expects the final top three PBM in the United States to execute a contract for their commercial lives in the first quarter of 2026.
    
    
  • 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 (for a total of two with the final one expected early Q1 2026). This agreement positions ORLYNVAH™ for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage of more than 10 million lives expected to begin as early as Q1 2026.
    
    
• FDA: The Company has requested a meeting from the U.S. Food & Drug Administration (“FDA”) to discuss a claim for the use of ORLYNVAH^TM as step-down therapy and the collection of real-world data to support the proposed claim. The FDA has determined that written responses to the Company’s questions would be the most appropriate means for responding to this meeting request. A goal date of January 24, 2026 has been set for the FDA to provide their written responses.
  
  

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 enter a a contract with the final top three PBM in the United States in Q1 2026, to secure additional Medicare Part D coverage in early 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 announce about ORLYNVAH coverage for 2026 (ITRM)?

Iterum announced a PBM-linked contract adding coverage for 24M+ lives starting early 2026 and Medicare Part D coverage for 10M+ lives as early as Q1 2026.

When will the final top-three PBM contract for ITRM be executed?

The company expects the final top-three PBM to execute a commercial contract for their lives in Q1 2026.

What Medicare Part D progress did Iterum report for ORLYNVAH (ITRM)?

Iterum signed a second rebate agreement with a top-three Medicare Part D PBM, positioning ORLYNVAH for formulary inclusion covering 10M+ lives starting as early as Q1 2026.

What did Iterum say about FDA interaction on ORLYNVAH (ITRM)?

Iterum requested an FDA meeting on a step-down therapy claim; the FDA opted to provide written responses with a goal date of January 24, 2026.

How soon will the new PBM coverage for ORLYNVAH take effect (ITRM)?

Coverage opportunities from the new PBM-linked Group Purchasing Organization agreement are expected to begin in early 2026.

Does the update guarantee nationwide insurer coverage for ITRM in 2026?

No guarantee was made; the company reported signed agreements that add coverage opportunities and expects remaining PBM and Medicare actions in Q1 2026.