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ACC Recommends Approved Drug for Lowering LDL


August 30, 2022 ( Newswire) This same medicine is currently being evaluated in a global clinical trial from which topline results are expected in Q1/23, noted an H.C. Wainwright & Co. report.

Esperion Therapeutics Inc.’s (ESPR:NASDAQ) Nexletol (bempedoic acid) has been recommended by an American College of Cardiology (ACC) task force as a non-statin, LDL cholesterol-lowing therapy, reported H.C. Wainwright & Co. analyst Joseph Pantginis in an August 26, 2022 research note. The recommendation was published in the online version of the Journal of the American College of Cardiology.

“This recommendation addresses the current gap in care for atherosclerotic cardiovascular disease (ASCVD) patients, particularly in high-risk individuals who cannot reach their LDL cholesterol goals with a statin alone,” Pantginis pointed out.

Currently, bempedoic acid is approved in the U.S. and the European Union (EU) as an oral, once-a-day LDL cholesterol-lowering drug for patients with ASCVD or heterozygous familial hypercholesterolemia.

The ACC task force based its recommendation on data from the Phase 3 CLEAR Tranquility and CLEAR Serenity trials. Both showed that bempedoic acid 180 mg daily in patients with statin-associated muscle symptoms but not taking a statin drug lowered their LDL cholesterol level by about 24.5% versus placebo.

“Taken together, we believe the strong clinical evidence, and now expert recommendation further support[s] the potential ability [of] bempedoic acid to reduce cardiovascular risk in patients with statin intolerance,” Pantginis commented.

The analyst indicated bempedoic acid is the subject of another trial, CLEAR Outcomes, for which topline results are anticipated in Q1/23, a potential stock moving event. This study involves more than 14,000 patients at 1,200 sites in 32 countries.

This randomized, placebo-controlled study will show whether or not treatment with bempedoic acid reduces the risk of cardiovascular events in patients with physician-documented statin intolerance and elevated LDL cholesterol levels. The primary endpoint is the effect of bempedoic acid on cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and coronary revascularization.

“If positive, CLEAR Outcomes is poised to define bempedoic acid as the go-to therapy for statin-intolerant patients,” wrote Pantginis. If positive, “we expect the adoption of bempedoic acid in statin-intolerant patients to be significant and to exceed our current penetration of 0.3% to 3.5% and 4% at peak sales in U.S. and EU, respectively.”

Lastly, Pantginis relayed that another trial involving bempedoic acid is in the works. With it, Esperion and Kaiser Permanente plan to evaluate bempedoic acid plus ezetimibe, or Nexlizet, in a high-risk group – patients with a recent acute coronary syndrome event.

“We expect the trial to generate key insights on the efficacy and safety of Nexlizet in a patient population often under-represented in clinical trials,” Pantginis added.

H.C. Wainwright & Co. has a Buy rating and a $22 per share price target on Esperion, the stock of which is trading now at around $7.67 per share.


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Disclosures For H.C.Wainwright & Co., Esperion Therapeutics Inc., Aug. 26, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Joseph Pantginis, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

A research analyst of the firm and/or the research analyst’s household has a financial interest in and own the securities of Esperion Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of July 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Esperion Therapeutics, Inc..

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Esperion Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Esperion Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Esperion Therapeutics, Inc. during the past 12 months.

The Firm does not make a market in Esperion Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.

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