Esperion’s Bempedoic Acid Receives Recommendation in 2025 ACC Scientific Statement on Management of Peripheral Artery Disease in Adults With Diabetes

Rhea-AI Summary

Esperion (NASDAQ: ESPR) said bempedoic acid was recommended by the 2025 ACC Scientific Statement for LDL-C lowering in adults with peripheral artery disease (PAD) and diabetes on maximally tolerated statins.

The statement endorses LDL-C reduction >50% and goal <55 mg/dL using therapies with proven cardiovascular benefit, listing bempedoic acid alongside high-intensity statins, ezetimibe, and PCSK9 inhibitors. Analysis cited from CLEAR Outcomes reported a 36% reduction in major adverse limb events (MALE) versus placebo. Product indications and safety risks for NEXLIZET and NEXLETOL are reiterated, including hyperuricemia and tendon rupture warnings.

Positive

• ACC endorsement of bempedoic acid for PAD with diabetes
• LDL-C target guidance: >50% reduction and <55 mg/dL
• MALE -36% with bempedoic acid vs placebo in CLEAR Outcomes

Negative

• Risk of hyperuricemia and potential gout with bempedoic acid
• Increased risk of tendon rupture or injury reported
• Common adverse events include renal impairment, anemia, and elevated liver enzymes

Key Figures

LDL-C reduction target >50% ACC recommendation for adults with PAD and diabetes

LDL-C goal <55 mg/dL ACC treatment goal for PAD and diabetes

MALE reduction 36% Bempedoic acid vs placebo in CLEAR Outcomes PAD subgroup

Year of ACC statement 2025 ACC Scientific Statement on PAD management in diabetes

Guideline timing early 2026 Anticipated U.S. dyslipidemia guidelines from ACC/AHA

AHA session year 2024 AHA Scientific Sessions presentation on limb outcomes

Market Reality Check

$3.71 Last Close

Volume Volume 4,041,219 is below 20-day average 6,447,730 (relative volume 0.63x). low

Technical Price $3.80 is trading above the 200-day MA at $1.95 and 7.99% below the 52-week high of $4.13.

Peers on Argus 1 Up

Peer moves are mixed: ORGO up 8.05%, AKBA up 2.45%, EOLS up 1.27%, SIGA down 0.79%, AQST flat. Momentum scanner only flags CGC up 6.57% with no news, suggesting ESPR’s action is stock-specific rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	Inducement grants	Neutral	+1.1%	Equity awards to new CCO and employees under inducement plan.
Nov 21	Japan launch	Positive	+4.4%	Otsuka launches NEXLETOL in Japan with $90M near-term payment and royalties.
Nov 19	Conference participation	Neutral	-1.4%	Piper Sandler conference presentation and webcast details disclosed.
Nov 18	Canada approval	Positive	+0.3%	Health Canada approval for NILEMDO to reduce LDL-cholesterol.
Nov 10	Clinical data update	Positive	+8.3%	CLEAR Outcomes post hoc analyses show LDL-C and MACE-4/VTE risk reductions.

Pattern Detected

Positive commercial or clinical updates have generally seen supportive price reactions, while neutral corporate events show occasional short-term divergence.

Recent Company History

Over the last few months, Esperion reported multiple milestones, including new CLEAR Outcomes data at AHA 2025 showing LDL-C reduction and lower VTE risk, and international expansion with NEXLETOL/NILEMDO launches and approvals in Japan and Canada. A Japan launch on Nov 21, 2025 and new clinical data on Nov 10, 2025 both coincided with price gains. Today’s ACC endorsement of bempedoic acid for PAD with diabetes builds on this pattern of strengthening clinical and guideline support for the franchise.

Market Pulse Summary

This announcement highlights that the 2025 ACC Scientific Statement recommends aggressive LDL-C lowering in adults with peripheral artery disease and diabetes and specifically includes bempedoic acid among first-line, evidence-based options when added to maximally tolerated statins. The article cites a 36% reduction in major adverse limb events from CLEAR Outcomes, building on prior positive data releases and expanding international approvals. Investors may watch how future ACC/AHA dyslipidemia guidelines in early 2026 incorporate these findings.

Key Terms

ldl-c medical

"Bempedoic Acid Highlighted by ACC for LDL-C Lowering in Patients..."

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.

peripheral artery disease medical

"on Management of Peripheral Artery Disease (PAD) in Adults with Diabetes."

A circulatory condition in which arteries that supply blood to the legs and feet become narrowed or blocked, reducing blood flow and causing pain, slow healing, or tissue damage—think of it as clogged pipes in the body’s lower limbs. It matters to investors because the prevalence, available treatments, and clinical trial or regulatory outcomes shape demand for drugs, devices, and care services, which can affect revenues, costs and valuation in healthcare-related businesses.

pcsk9 inhibitors medical

"High-intensity statins, reinforced by ezetimibe, PCSK9 inhibitors, or bempedoic acid..."

PCSK9 inhibitors are a class of prescription medicines that lower levels of harmful LDL cholesterol by blocking a protein (PCSK9) that otherwise reduces the liver’s ability to remove cholesterol from the bloodstream. They matter to investors because they can change treatment patterns and healthcare spending—offering a more effective option for patients who don’t respond to standard drugs, which affects drug sales, insurance coverage, and potential regulatory scrutiny much like a superior filter replacing an older one.

major adverse limb events medical

"The analysis focused on the incidence of major adverse limb events (MALE)..."

Major adverse limb events are serious medical outcomes affecting an arm or leg, such as major amputation, urgent limb-saving surgery, or permanent loss of limb function due to poor blood flow or tissue damage. Investors should care because these outcomes drive how regulators and doctors judge the safety and effectiveness of vascular treatments and devices; like a product recall for a car, frequent severe limb complications can limit sales, reimbursement and market acceptance.

myocardial infarction medical

"events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization)..."

Myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked and heart muscle is damaged—like a garden hose being pinched so a patch of lawn starts to die. For investors, heart attacks matter because they drive demand for drugs, devices, hospitals and rehabilitation, affect health-care costs and workforce productivity, and can lead to regulatory actions, litigation or shifts in insurance and pricing that impact company earnings.

coronary revascularization medical

"events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization)..."

A medical procedure that restores blood flow to the heart by clearing or bypassing blocked arteries, often with devices like stents or surgical grafts; think of it as unclogging or creating a detour around a blocked pipe to let blood move freely. It matters to investors because the volume, cost, outcomes and regulatory approval of these procedures influence demand for medical devices, hospital revenues, drug and device company earnings, and health-care spending trends.

hyperuricemia medical

"Hyperuricemia: Bempedoic acid... may increase blood uric acid levels..."

Hyperuricemia is a medical condition where uric acid builds up in the blood at higher-than-normal levels, similar to a sink that isn’t draining properly and allows residue to accumulate. It matters to investors because it is the underlying risk factor for gout and kidney stones and a target for drugs and diagnostics; changes in its prevalence, treatment options, or regulatory guidance can affect market size, company revenues, and healthcare spending.

tendon rupture medical

"Tendon Rupture: Bempedoic acid... is associated with an increased risk of tendon rupture..."

A tendon rupture is a complete tear of the tough cord-like tissue that connects a muscle to a bone, like a rope snapping and disconnecting a pulley. For investors, it matters because such injuries can drive demand for medical treatments, surgeries, rehabilitation services, and related drug or device approvals; they can also influence clinical trial outcomes, insurance costs, and revenue forecasts for healthcare companies.

AI-generated analysis. Not financial advice.

– Bempedoic Acid Highlighted by ACC for LDL-C Lowering in Patients with Peripheral Artery Disease and Diabetes Based on Proven Cardiovascular and Limb Benefits –

ANN ARBOR, Mich., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) welcomed the inclusion of bempedoic acid as a first-line, evidence-based therapy for LDL-C lowering for patients on maximally tolerated statins in the 2025 American College of Cardiology (ACC) Scientific Statement on Management of Peripheral Artery Disease (PAD) in Adults with Diabetes.

“We recognize the significance of the American College of Cardiology’s scientific statement highlighting the importance of aggressive LDL-C lowering in patients with diabetes and peripheral artery disease. The inclusion of bempedoic acid reinforces its important role as a proven, evidence-based therapy for reducing both cardiovascular and limb risk in high-risk populations,” said Sheldon Koenig, CEO of Esperion.

”This statement provides clinicians with valuable insight to help close treatment gaps. This scientific statement reinforces the valuable role bempedoic acid plays in cardiovascular risk reduction. As we anticipate the forthcoming U.S. dyslipidemia treatment guidelines from ACC/American Heart Association (AHA) in early 2026, it also strengthens our confidence that bempedoic acid will be included in those recommendations, consistent with its prominent endorsement in the European guidelines issued in August,” concluded Koenig.

Key ACC Recommendations for LDL-C Lowering in Adults with PAD and Diabetes

1. Treatment of LDL-C to a target reduction >50% and goal <55 mg/dL is recommended, using therapies with proven cardiovascular benefit.
2. High-intensity statins, reinforced by ezetimibe, PCSK9 inhibitors, or bempedoic acid as needed, effectively reduce cardiovascular and limb risk.

The scientific statement, entitled “Management of peripheral artery disease in adults with diabetes: 2025 ACC scientific statement; a report of the American College of Cardiology,” was published in the Journal of the American College of Cardiology. The full scientific statement is available via open access here.

This scientific statement incorporates data from the 2024 AHA Scientific Sessions Featured Science Presentation “Bempedoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease” presented on behalf of all authors by Marc P. Bonaca, MD, MPH, FAHA, FACC, CPC Clinical Research with manuscript under review. The analysis focused on the incidence of major adverse limb events (MALE) in patients with pre-existing PAD enrolled in the CLEAR Outcomes trial. Bempedoic acid reduced MALE (e.g. worsening PAD symptoms leading to revascularization, chronic limb threatening ischemia, and acute limb ischemia events) by 36% compared to placebo and supports bempedoic acid as an oral, safe, and well tolerated option for lowering LDL-C and the risk of major adverse limb events in patients with PAD.

INDICATION
NEXLIZET and NEXLETOL are indicated:

• The bempedoic acid 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).
  • NEXLIZET, to reduce LDL-C in adults with hypercholesterolemia, including HeFH.
  • NEXLETOL, 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. Hyperuricemia may occur early in treatment and persist throughout treatment, returning to baseline following discontinuation of treatment. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. 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 hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, 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.

In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported 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, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.

Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL.

Report pregnancies to Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.

Please see full Prescribing Information for NEXLIZET and NEXLETOL.

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 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, 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

FAQ

What did the 2025 ACC Scientific Statement recommend about LDL-C targets for adults with PAD and diabetes?

The statement recommends LDL-C reduction of >50% and a goal of <55 mg/dL using therapies with proven cardiovascular benefit.

How did bempedoic acid perform on limb outcomes in the CLEAR Outcomes analysis mentioned for ESPR?

The analysis reported a 36% reduction in major adverse limb events (MALE) with bempedoic acid versus placebo among patients with PAD.

How does the ACC statement position bempedoic acid relative to other LDL-C therapies for PAD and diabetes?

The statement lists bempedoic acid alongside high-intensity statins, ezetimibe, and PCSK9 inhibitors as options to reduce cardiovascular and limb risk when needed.

What indications for NEXLIZET and NEXLETOL are reiterated in the release about ESPR?

The release reiterates indications to reduce major adverse cardiovascular events in statin-intolerant adults and to reduce LDL-C in adults with hypercholesterolemia, including HeFH.

What are the main safety concerns investors should note about bempedoic acid in ESPR products?

Key safety concerns include hyperuricemia (risk of gout), increased risk of tendon rupture, and other adverse events such as renal impairment and elevated liver enzymes.

Could the ACC statement influence U.S. dyslipidemia guidelines for bempedoic acid in early 2026?

The company said the ACC endorsement strengthens confidence that bempedoic acid may be included in forthcoming ACC/AHA dyslipidemia guidance expected in early 2026.