Esperion Presents New Data from CLEAR Outcomes and the CLEAR PATH Phase 2 Pediatric Study at the European Atherosclerosis Society Congress 2026
Rhea-AI Summary
Esperion (NASDAQ: ESPR) presented new bempedoic acid data at the European Atherosclerosis Society Congress 2026. A Phase 2 CLEAR Path 1 study in children aged 6-17 with heterozygous familial hypercholesterolemia showed weight-based dosing achieved adult-like exposure and LDL-C reductions of about 6-25% without new safety signals.
A CLEAR Outcomes post hoc analysis in statin-intolerant adults found 42% of bempedoic acid patients achieved ≥30% LDL-C reduction at 3 months, with greater response linked to female sex, higher baseline LDL-C and concurrent ezetimibe use.
AI-generated analysis. Not financial advice.
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Key Figures
Market Reality Check
Peers on Argus
ESPR was flat over the prior day, while peers showed mixed, mostly negative moves (e.g., AQST -3.29%, EOLS -6.31%, ORGO +0.38%). This suggests today’s clinical data are stock-specific rather than part of a broad sector rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 17 | CLEAR Outcomes data | Positive | +0.7% | New CLEAR Outcomes analyses in underrepresented statin-intolerant patient subgroups. |
| Oct 16 | Preclinical candidate | Positive | +5.2% | Nomination of ESP-2001 for primary sclerosing cholangitis with IND planned for 2026. |
| Oct 3 | Patent settlement | Positive | +13.8% | Settlement delaying U.S. generics for NEXLETOL/NEXLIZET until at least April 2040. |
| Aug 29 | Guideline upgrade | Positive | +0.5% | ESC/EAS guidelines granting bempedoic acid a Level 1a dyslipidaemia recommendation. |
| Mar 20 | Pediatric trial plan | Positive | -3.0% | FDA alignment to start Phase 3 pediatric trials for HeFH and HoFH populations. |
Clinical and guideline-related updates have generally led to modest positive moves, with one notable divergence on pediatric Phase 3 planning news.
Over the past year, clinical and guideline milestones have steadily expanded Esperion’s bempedoic acid franchise. A Mar 17, 2026 CLEAR Outcomes analysis in underrepresented populations, an Oct 2025 preclinical nomination (ESP-2001), and an ESC/EAS Level 1a guideline upgrade all supported the LDL-C and cardiovascular risk profile. FDA alignment in March 2025 to initiate pediatric Phase 3 trials directly connects to today’s EAS data, which provide Phase 2 evidence in children and refine responder characteristics in statin-intolerant adults.
Historical Comparison
In the past year, clinical-trial and development updates for ESPR saw an average move of about 3.43%, giving a reference frame for interpreting this EAS Congress Phase 2 and CLEAR Outcomes analysis news.
Clinical news shows a progression from guideline recognition and adult CLEAR Outcomes data to regulatory alignment for pediatric Phase 3, culminating in today’s Phase 2 pediatric results that help bridge into those planned registrational studies.
Market Pulse Summary
This announcement adds Phase 2 pediatric evidence that bempedoic acid reduces LDL-C by 6–25% without new safety concerns and refines which statin‑intolerant adults achieve ≥30% LDL-C reductions (42% in CLEAR Outcomes). It builds on prior guideline endorsements and pediatric Phase 3 planning. Investors following the story may watch for full Phase 3 data, long‑term safety in younger patients, and how these findings integrate with the pending $3.16-per-share acquisition structure.
Key Terms
ldl-c medical
familial hypercholesterolemia medical
heterozygous familial hypercholesterolemia medical
statin intolerant medical
phase 2 medical
phase 3 medical
major adverse cardiovascular events medical
myocardial infarction medical
AI-generated analysis. Not financial advice.
– Bempedoic Acid Lowered LDL-C and Was Well Tolerated in Children Aged 6-17 Years –
– A Secondary Analysis of CLEAR Outcomes Reports on Patient Factors Associated With
ANN ARBOR, Mich., May 26, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of results from a Phase 2 study of bempedoic acid in children, along with an additional post hoc analysis from CLEAR Outcomes describing patient traits associated an enhanced LDL-C lowering with bempedoic acid. These data were presented as moderated Science at a Glance sessions at the European Atherosclerosis Society (EAS) Congress 2026 taking place on May 24-27, 2026, in Athens, Greece.
“The data from CLEAR Path 1 in pediatric patients with familial hypercholesterolemia gives promise for bempedoic acid as a potentially safe and effective additional lipid lowering agent for use in children who carry a greater lifetime cardiovascular risk and will further inform Phase 3 studies,” said Christie M Ballantyne, MD, Professor of Medicine and Chief of Cardiology and Cardiovascular Research at Baylor College of Medicine and member of the Esperion Pediatric Study Steering Committee. “The
“These new analyses add to the breadth of clinical evidence demonstrating the robust LDL cholesterol lowering of NEXLETOL® (bempedoic acid) across a wide range of patient populations,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “These data further support use of our combination product NEXLIZET® (bempedoic acid/ezetimibe) to help patients achieve their LDL-C goals and reduce cardiovascular risk. We are also proud to present data supporting the use of bempedoic acid in children with heterozygous familial hypercholesterolemia and which informs our Phase 3 pediatric studies.”
Key data presented at EAS Congress 2026
- Bempedoic Acid In Children Aged 6-17 Years With Heterozygous Familial Hypercholesterolaemia: A Phase 2 Study presented by Samuel S Gidding, MD (Geisinger Health)
Highlights
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- The variable dosing of bempedoic acid, as determined by patient weight in this study, resulted in similar drug exposure (levels) to that in adults, and supports the doses of bempedoic acid to be used in further clinical studies.
- Bempedoic acid, when given as a tablet in addition to patient’s existing lipid lowering treatments, reduced LDL-C in pediatric patients (range 6
-25% ) and did not raise any new safety concerns.
- Factors Associated With Enhanced LDL-Cholesterol Lowering With Bempedoic Acid Among Statin-Intolerant Patients From Clear Outcomes presented by Christie M Ballantyne, MD (Baylor College of Medicine)
Highlights
-
- In CLEAR Outcomes,
42% of patients in the bempedoic acid arm demonstrated a ≥30% LDL‐C reduction at 3 months, a reduction on par with moderate intensity statins. - Patient factors associated with achieving a greater LDL-C reduction included female sex, higher starting LDL-C, and concurrent use of ezetimibe.
- In CLEAR Outcomes,
INDICATION
NEXLIZET and NEXLETOL are indicated:
- bempedoic acid, a component of NEXLIZET and NEXLETOL, is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin).
- as an adjunct to diet and exercise:
- NEXLIZET is indicated to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
- NEXLETOL is indicated, in combination with other LDL-C lowering therapies or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
IMPORTANT SAFETY INFORMATION
- NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
- Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels, which may lead to gout. Monitor as clinically indicated and initiate treatment with urate-lowering drugs as appropriate.
- Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred in
0.5% of patients treated with bempedoic acid in primary hypercholesterolemia trials, versus0% on placebo. In the cardiovascular outcomes trial, the rates were1.2% for bempedoic acid and0.9% for placebo. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture. - The most common adverse reactions in the primary hypercholesterolemia trials of bempedoic acid in ≥
2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. - Adverse reactions reported in ≥
2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. - The most common adverse reactions (incidence ≥
3% and greater than placebo) observed with NEXLIZET but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation. - The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, at an incidence of ≥
2% and0.5% greater than placebo, were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. - Concomitant use of NEXLIZET or NEXLETOL with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided due to the potential for increased risk of simvastatin- or pravastatin-related myopathy. Concomitant use with fibrates may increase triglycerides and decrease high-density lipoprotein cholesterol. Monitor and adjust therapies as recommended.
- Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. The benefits of breastfeeding should be considered along with the mother’s clinical need for NEXLIZET or NEXLETOL and any potential adverse effects on the breastfed infant from NEXLIZET or NEXLETOL or from the underlying maternal condition.
Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company dedicated to developing and delivering innovative cardiometabolic and rare/orphan disease therapies. The Company leverages deep domain expertise in ACLY biology to develop and commercialize transformative medicines for patients worldwide. Esperion currently markets two oral, once-daily, non-statin therapies for patients struggling to maintain their low-density lipoprotein cholesterol (LDL-C) levels and are at risk of cardiovascular disease.
With a broad U.S. commercial infrastructure and global approvals across more than 40 countries, Esperion is well positioned to serve as a partner-of-choice for global innovators seeking U.S. market access through acquisition, in-license, co-promotion and revenue share opportunities. In tandem, the Company is advancing its leadership in ACLY biology to build a diversified pipeline of novel product candidates, including treatments for Primary Sclerosing Cholangitis and renal diseases. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization and business development plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, business development, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438