Keenova Presents a New TERLIVAZ® (terlipressin) Clinical Analysis at Digestive Disease Week

Rhea-AI Summary

Keenova (NASDAQ:MNK) will present new clinical analysis of TERLIVAZ® (terlipressin) at Digestive Disease Week, May 2-5, 2026. The presentation reports preliminary real-world treatment patterns and outcomes for hepatorenal syndrome-acute kidney injury (HRS-AKI) from seven U.S. hospitals and aims to inform clinical practice.

Market Context

This announcement highlighted new real-world data on TERLIVAZ use in HRS-AKI from seven US hospitals...

Analysis

This announcement highlighted new real-world data on TERLIVAZ use in HRS-AKI from seven US hospitals, adding detail on treatment patterns and outcomes in everyday practice. As TERLIVAZ is described as the first FDA‑approved therapy for this indication, investors may track how expanding evidence influences physician behavior, guideline inclusion, and long-term utilization, while also watching for future updates that link these findings to commercial performance.

Key Figures

Participating hospitals: seven US hospitals

1 metrics

Participating hospitals seven US hospitals Real-world terlipressin treatment patterns and outcomes analysis

Key Terms

hepatorenal syndrome-acute kidney injury, hrs-aki, terlipressin, fda‑approved

4 terms

hepatorenal syndrome-acute kidney injury medical

"Real-world terlipressin treatment patterns and outcomes in hepatorenal syndrome-acute kidney injury"

A severe complication in people with advanced liver disease where the kidneys suddenly stop working because blood flow and body chemistry are altered by the failing liver. Think of the liver as a central pump that keeps pipes and filters supplied; when it fails, the kidneys (filters) can shut down even though they are not directly damaged. For investors, it matters because the condition drives urgent medical care, creates demand for specific drugs and devices, and is a common endpoint in clinical trials and regulatory decisions for liver- and kidney-related therapies.

hrs-aki medical

"Real-world terlipressin treatment patterns and outcomes in hepatorenal syndrome-acute kidney injury (HRS-AKI)"

HRS-AKI is a sudden, severe loss of kidney function that occurs in people with advanced liver disease when the organs stop coordinating properly, like a plumbing system where a blocked main pipe causes downstream pumps to fail. It matters to investors because it represents a serious unmet medical need that drives hospital stays, high treatment costs, and a clear regulatory and commercial pathway for therapies or diagnostics; progress or setbacks in HRS-AKI programs can materially affect the value of companies working in liver and kidney disease.

terlipressin medical

"treatment patterns, and outcomes associated with terlipressin use in U.S. practice"

Terlipressin is a prescription medicine that acts like a strong “squeeze” on blood vessels to raise blood pressure and redirect blood flow, commonly used to treat life‑threatening complications of advanced liver disease such as kidney failure linked to cirrhosis and severe bleeding from swollen veins. Investors track terlipressin because its trial results, regulatory approvals, safety signals and pricing determine market access and potential revenue for developers, while adverse effects or limited benefit can sharply affect a drug’s commercial prospects.

fda‑approved regulatory

"TERLIVAZ is the first and only FDA‑approved therapy indicated to improve kidney function"

FDA-approved means a medical product, such as a drug, device, or diagnostic, has passed the U.S. Food and Drug Administration’s tests for safety and effectiveness for a specific use. For investors, approval is like receiving a highway permit: it clears major regulatory hurdles to sell the product widely, can unlock revenue and market access, and reduces uncertainty about legal and clinical risks.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

DUBLIN, May 1, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced today that a new presentation on hepatorenal syndrome-acute kidney injury (HRS‑AKI) and TERLIVAZ^® (terlipressin) will be shared at Digestive Disease Week (DDW), taking place May 2-5, 2026.

"We are pleased to share these findings with the medical community, as they expand the clinical evidence and advance our understanding of this challenging and rapidly progressive condition," said Dr. Marek Honczarenko, Executive Vice President and Chief Scientific Officer at Keenova. "These data improve understanding of characteristics, treatment patterns, and outcomes associated with terlipressin use in U.S. practice, helping inform efforts to support care for patients with HRS-AKI."

TERLIVAZ is the first and only FDA‑approved therapy indicated to improve kidney function in adults with HRS‑AKI.

Presentation Details

• Title: Real-world terlipressin treatment patterns and outcomes in hepatorenal syndrome-acute kidney injury (HRS-AKI): Preliminary data from seven US hospitals
• Authors: Stevan A. Gonzalez, MD; Aanchal Kapoor, MD; A. Sidney Barritt IV, MD, MSCR; Xingyue Huang, PhD; Sneha S. Kelkar, MSc, MPH; Rishi P. Verma, MPH; Malinda Tan, PharmD; Jordana K. Schmier, MA; Mary Panaccio, PhD; R. Todd Frederick, MD; Christopher White, MD, MSPH

About Hepatorenal Syndrome-Acute Kidney Injury
Hepatorenal syndrome–acute kidney injury (HRS-AKI) is a life-threatening condition in adults with advanced liver disease that is marked by a rapid decline in kidney function¹ and is associated with high morbidity and mortality.² It is an acute medical emergency that requires hospitalization.³ A U.S. study based on national data revealed that the projected annual number of inpatients diagnosed with HRS has increased between 2018 and 2023, from 42,930 to 63,381.⁴

INDICATION 
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

LIMITATION OF USE

• Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

• TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO₂) before initiating TERLIVAZ. 
   
• Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO₂ <90%) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO₂ decreases below 90%.

Contraindications
TERLIVAZ is contraindicated:

• In patients experiencing hypoxia or worsening respiratory symptoms.
• In patients with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

• Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.
   
  Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
   
• Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed. For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
   
• Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
   
• Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Adverse Reactions

• The most common adverse reactions (≥10%) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.

Please click here to see full Prescribing Information, including BOXED WARNING.

About Keenova 
Keenova Therapeutics is a leading U.S.-focused branded therapeutics company that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

Keenova's rare disease capabilities underpin our diversified brands portfolio, which is focused across a wide range of specialty therapeutic areas of significant unmet need. These include rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics, urology, and neonatal respiratory critical care.

Headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania, and Wisconsin. To learn more, please visit www.keenova.com.

Keenova uses its website as a channel of distribution of important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to time-critical information regarding the Company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission ("SEC") disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

Information Regarding Forward-Looking Statements
This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Keenova's most recent Annual Report on Form 10-K, and other filings and furnishings with the Securities and Exchange Commission (SEC), all of which are available on the SEC's website (www.SEC.gov) and Keenova's website (www.keenova.com). The forward-looking statements made herein speak only as of the date hereof and Keenova does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

References

1. Wong RJ, Balasubramanian J, Panaccio M, Huang X. Acute kidney injury and hepatorenal syndrome among hospitalized patients with chronic liver disease. JAMA Netw Open. 2025;8(5):e2511816.
2. Loftus M, Brown RS Jr, El-Farra NS, Owen EJ, Reau N, Wadei HM, Bernstein D. Improving the management of hepatorenal syndrome–acute kidney injury using an updated guidance and a new treatment paradigm. Gastroenterol Hepatol (N Y). 2023;19(9):527-536.
3. National Organization for Rare Disorders. Hepatorenal syndrome. Available at https://rarediseases.org/rare-diseases/hepatorenal-syndrome. Accessed March 17, 2026.
4. Goyes M, et al. Increasing incidence, cost, and mortality of AKI and HRS in hospitalized patients with cirrhosis. JAMA Netw Open. 2025;8(5):e2511822.

 

Contacts
Media:	Investors:
media.relations@keenova.com	investor.relations@keenova.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/keenova-presents-a-new-terlivaz-terlipressin-clinical-analysis-at-digestive-disease-week-302758892.html

SOURCE Keenova Therapeutics

FAQ

What did Keenova (MNK) present at Digestive Disease Week (May 2-5, 2026)?

Keenova presented preliminary real-world data on TERLIVAZ treatment patterns and outcomes in HRS-AKI patients. According to the company, the analysis reports findings from seven U.S. hospitals and is intended to expand clinical evidence and inform U.S. practice for this condition.

What is TERLIVAZ (terlipressin) and what indication does it have for HRS-AKI?

TERLIVAZ is an FDA-approved therapy indicated to improve kidney function in adults with HRS-AKI. According to the company, TERLIVAZ is the first and only therapy with that FDA indication for this rapidly progressive condition.

How many hospitals and what type of data did Keenova report for TERLIVAZ at DDW 2026?

The presentation reported preliminary real-world data from seven U.S. hospitals on terlipressin use and outcomes in HRS-AKI. According to the company, the dataset focuses on treatment patterns, patient characteristics, and clinical outcomes in U.S. practice.

Does the DDW presentation change TERLIVAZ regulatory status or label for MNK?

No regulatory change was announced in the presentation materials; it reported clinical analysis only. According to the company, the session shares real-world evidence to expand understanding but did not state any new FDA actions.

Where can investors and clinicians find details of Keenova's TERLIVAZ DDW presentation (MNK)?

Presentation details list title, authors, and DDW timing (May 2-5, 2026) for the TERLIVAZ analysis. According to the company, attendees can view the presentation at DDW and consult company communications for any posted slides or abstracts.