STOCK TITAN

Amarin Reaffirms the Proven, Guideline-Recommended Role of VASCEPA® (Icosapent Ethyl) in an Evolving Triglyceride Treatment Landscape 

(Moderate)
(Positive)
Tags

Amarin (NASDAQ: AMRN) highlights the role of VASCEPA (icosapent ethyl) in treating severe hypertriglyceridemia (sHTG) amid new injectable APOC3 therapies. VASCEPA delivers a 33% median TG reduction, broad cardiovascular risk reduction, and guideline support, with an annual WAC of about $4,200 versus $40,000 for some injectables.

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Positive

  • VASCEPA delivers 33% median triglyceride reduction in sHTG, with ~50% reaching <500 mg/dL at 12 weeks
  • Triglyceride reductions achieved without LDL-C increases seen with some other triglyceride-lowering agents in sHTG
  • Annual VASCEPA wholesale acquisition cost about $4,200 versus $40,000 for some APOC3 injectables
  • More than 30 million VASCEPA prescriptions globally for patients with elevated triglycerides
  • First and only FDA-approved therapy cutting cardiovascular event risk by 25% when added to a statin in high-risk patients
  • Role of VASCEPA reaffirmed in 2026 ACC/AHA/Multisociety Dyslipidemia Guideline and endorsed by 70+ medical societies

Negative

  • None.

News Market Reaction – AMRN

+3.32%
+3.32% Session close to close

In the Jul 1 session, AMRN gained 3.32%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reinforces VASCEPA’s role with 33% triglyceride reduction, broad guideline backing...
Analysis

This announcement reinforces VASCEPA’s role with 33% triglyceride reduction, broad guideline backing, and lower listed cost versus APOC3 injectables. With modest short positioning, competition and payer controls remain key risks while future data and utilization trends bear watching.

Key Figures

sHTG definition: ≥500 mg/dL triglycerides Triglyceride reduction: 33% median reduction Patients below 500 mg/dL: ≈50% of patients +5 more
8 metrics
sHTG definition ≥500 mg/dL triglycerides Threshold used for severe hypertriglyceridemia in this announcement
Triglyceride reduction 33% median reduction VASCEPA vs placebo in patients with severe hypertriglyceridemia
Patients below 500 mg/dL ≈50% of patients Achieved TG <500 mg/dL at 12 weeks on VASCEPA
APOC3 therapy cost $40,000 annual WAC Most recent injectable APOC3 therapy per patient
VASCEPA cost $4,200 annual WAC VASCEPA per patient wholesale acquisition cost
CV risk reduction 25% reduction Risk of cardiovascular events when VASCEPA added to statin in high-risk patients
Prescription volume 30+ million prescriptions Global use of VASCEPA in patients with elevated triglycerides
Guideline support 70+ medical societies Organizations recognizing importance of icosapent ethyl

Historical Context

5 past events · Latest: May 27 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 27 Clinical data update Positive +1.5% REDUCE-IT placebo-arm analysis highlighting RW-apoB for better risk stratification.
Apr 29 Earnings results Positive +2.4% Q1 2026 revenue growth, lower expenses, and improved cash flow and losses.
Apr 15 Earnings call notice Neutral +4.5% Announcement of schedule for first-quarter 2026 results and conference call.
Apr 08 Conference highlights Positive +0.3% ACC 2026 data underscoring need for complementary therapies including icosapent ethyl.
Mar 18 Guideline update Positive -3.7% Updated ACC/AHA dyslipidemia guideline recognizing icosapent ethyl for risk reduction.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

AMRN has generally traded higher on scientific and guideline-related updates, with one notable selloff following a positive guideline endorsement.

Key Terms

apolipoprotein c-iii, hypertriglyceridemia, ldl-c, pharmacy benefit managers, +2 more
6 terms
apolipoprotein c-iii medical
"applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies"
Apolipoprotein C‑III is a small protein that rides on fat-carrying particles in the blood and helps control how the body moves and breaks down triglyceride fats; think of it as a traffic light that slows the removal of fat from the bloodstream. Because higher levels are linked to elevated triglycerides and greater heart disease risk, it serves as a biomarker and drug target, so changes in research or therapies around it can affect companies and investor value.
hypertriglyceridemia medical
"for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG)"
An unusually high level of triglycerides — a type of fat carried in the bloodstream — that signals an increased risk of heart disease and related health problems. For investors, it matters because the size of the patient population, effectiveness of treatments, regulatory approvals, and insurance coverage can drive demand, clinical-trial outcomes, and revenue for drugmakers and medical-device companies; think of it like too much oil in an engine increasing the need for maintenance and repairs.
ldl-c medical
"without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents"
LDL-C stands for low-density lipoprotein cholesterol, the portion of cholesterol carried in the blood by LDL particles that is commonly linked to buildup of plaque in arteries—think of it like sticky debris that can clog pipes. Investors care because changes in LDL-C are a key measure used by regulators and clinicians to judge the effectiveness of cardiovascular drugs and devices, shape insurance coverage, and influence market demand for treatments that lower heart attack and stroke risk.
pharmacy benefit managers financial
"many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow"
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.
prior authorization regulatory
"managing utilization of premium priced therapies through judicious prior authorization and step-therapy"
Prior authorization is a process where a health insurance company requires approval before covering certain medical services or medications. It functions like a pre-approval step, ensuring that the treatment is necessary and appropriate before expenses are paid. For investors, understanding prior authorization is important because delays or denials can impact healthcare costs, provider operations, and the financial stability of related companies.
step-therapy regulatory
"through judicious prior authorization and step-therapy requirements"
A health-plan policy that requires patients to try one or more established, usually lower-cost treatments before the insurer will pay for a newer or more expensive option. For investors, step therapy matters because it can delay or limit sales and market penetration for higher-priced drugs or therapies even after regulatory approval, much like a shop insisting customers try a discount product before allowing purchase of a premium version.

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

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Clinically Validated, Increasingly Prescribed, Widely Reimbursed, and Affordable, VASCEPA Expected to Benefit from Increased Attention to Patients with Severely Elevated Triglycerides

DUBLIN, Ireland and BRIDGEWATER, N.J., June 30, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease worldwide, applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL.i These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis.

“The renewed attention triglycerides generated by the introduction of innovative therapies is welcome, as they help to drive patient–physician conversations and bring critical awareness to the dangers of very high triglyceride levels,” said Aaron Berg, CEO of Amarin. “We recognize the important therapeutic advancement that APOC3 therapies represent and are optimistic about their potential benefit in patients at high risk of acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. We remain mindful that issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. Therefore, we are confident that VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia.”

Mr. Berg noted the following:

  • Robust Reductions in sHTG Without LDL-C Increases: VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks.ii,iii These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG.iv,v,vi  
  • Lower Cost, Proven Efficacy, and Broad Access: There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements.vii  
  • Elevated Triglyceride Patients are at Increased Risk for Cardiovascular Disease: VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors.viii  
  • Global Guideline Support Recently Reaffirmed: 70+ leading medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology / American Heart Association / Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides.i


Mr. Berg concluded, “We fully appreciate the potential benefits of recently introduced therapies for the segment of sHTG patients who are at high risk of acute pancreatitis. However, for the majority of the sHTG patient population, and for the broader global population of patients with elevated triglycerides at risk for cardiovascular events, significant clinical and economic value will be derived from prioritizing treatments such as VASCEPA that are proven, safe, commonly prescribed, affordable, and widely reimbursed.”

About Amarin 

Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. 

About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules 

VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. 

United States Indications and Limitation of Use

VASCEPA is indicated:  

  • As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.  
  • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.


The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. 

Important Safety Information 

  • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
  • VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
  • It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
  • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
  • Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
  • Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
  • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
  • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.


FULL U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Europe 

For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf  

Globally, prescribing information varies; refer to the individual country product label for complete information.

Forward-Looking Statements 

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. 

Amarin Contact Information 

Media Inquiries:  
Tegan Berry  
Amarin Corporation plc  
PR@amarincorp.com  

Investor Inquiries:
Devin Sullivan & Conor Rodriguez  
The Equity Group on Behalf of Amarin   
devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com 
Investor.relations@amarincorp.com 

i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of print
ii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015.
iii Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl). Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
iv https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21cfa4ce-0b05-47ed-b268-339eb1b83b75
v https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf
vi Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761.
vii Annual wholesale acquisition cost: published WAC pricing / data on file. [Medi-Span® Price Rx Pro®”]
viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792


FAQ

How does VASCEPA benefit patients with severe hypertriglyceridemia (sHTG) according to Amarin (NASDAQ: AMRN)?

VASCEPA is reported to significantly lower triglycerides in sHTG without raising LDL cholesterol. According to Amarin, patients saw a 33% median triglyceride reduction versus placebo, and about 50% achieved triglyceride levels below 500 mg/dL after 12 weeks of treatment.

What cardiovascular risk reduction is associated with VASCEPA for AMRN investors to know?

VASCEPA is described as the first and only FDA-approved therapy to reduce cardiovascular events by 25% when added to a statin. According to Amarin, this applies to high-risk patients with elevated triglycerides and additional cardiovascular risk factors.

How does VASCEPA pricing compare to new injectable APOC3 therapies for sHTG?

VASCEPA has a much lower annual wholesale acquisition cost than some APOC3 injectables. According to Amarin, VASCEPA’s WAC is about $4,200 per patient per year, versus $40,000 annually for a recently introduced injectable APOC3 therapy.

What guideline support does VASCEPA have in 2026 for elevated triglycerides?

VASCEPA’s role in triglyceride management has been reaffirmed in major dyslipidemia guidelines. According to Amarin, the 2026 ACC/AHA/Multisociety Dyslipidemia Guideline recognizes established triglyceride-lowering therapies, including VASCEPA, and over 70 leading medical societies support icosapent ethyl based on clinical data.

How widely is VASCEPA prescribed and reimbursed for elevated triglycerides?

VASCEPA is described as commonly prescribed and broadly accessible for patients with elevated triglycerides. According to Amarin, it has been prescribed more than 30 million times globally and is portrayed as affordable and widely reimbursed in the severe hypertriglyceridemia population.

What does the rise of APOC3 injectable therapies mean for VASCEPA and AMRN?

Amarin views APOC3 therapies as complementary innovations for high-risk sHTG patients, not replacements. According to Amarin, VASCEPA should remain a foundational, first-line, guideline-recommended option given its clinical profile, lower cost, and broad patient eligibility.