Stock Monitor: Achillion Pharma Post Earnings Reporting
LONDON, UK / ACCESSWIRE / May 4, 2018 / If you want access to our free research report on Esperion Therapeutics, Inc. (NASDAQ: ESPR) all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ESPR as the Company's latest news hit the wire. On May 2, 2018, the Company announced positive top-line results from the second pivotal, Phase-3 study (Study 1/1002-040) the long-term safety study, evaluating the safety, tolerability, and efficacy of bempedoic acid versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) who are inadequately controlled with current lipid-modifying therapies, including maximally tolerated statin therapy. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Esperion Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
Study 1 (1002-040) Met its Primary Endpoint
The 52-week, global, pivotal Phase-3 randomized, double-blind, placebo-controlled, multicenter study enrolled 2,230 patients with ASCVD. The study was conducted at 117 sites in the US, Canada, and Europe. It met the primary endpoint of safety and tolerability and the key efficacy endpoint with on-treatment low-density lipoprotein cholesterol (LDL-C) lowering of an additional 20% at 12 weeks (p<0.001). Patients treated with bempedoic acid also achieved a significant reduction of 22% in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease.
In this 52-week study, bempedoic acid was observed to be safe and well-tolerated. The occurrence of adverse events (AEs) in bempedoic acid and placebo groups was 78.5% and 78.7%, respectively; or serious adverse events (SAEs) was 14.5% and 14%, respectively. In the study, 0.54% and 0.13% of patients treated with bempedoic acid and placebo group, respectively, had elevations in liver function tests (ALT/AST) of greater than three times the upper limit of normal, repeated and confirmed. The cumulative number of patients now treated with bempedoic acid in Phase-2 and Phase-3 clinical trials total 2,434, of this 0.58 % had elevations in liver function tests greater than three times the upper limit of normal. This rate of elevations in liver function test is consistent with the rate observed in all other previously approved oral LDL-C-lowering therapies. Esperion will present full results from this study at an upcoming medical conference.
Esperion to Submit New Drug Applications to FDA in Q1 2019
Esperion plans to submit New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for bempedoic acid and the bempedoic acid/ ezetimibe combination pill for LDL-C-lowering indications in Q1 2019. Additionally, Esperion plans to submit Marketing Authorization Applications (MAAs) to the European Medicines Agency (EMA) in Q2 2019.
As per mainstream media reports post the announcement of the news, Esperion's shares plummeted in pre-market trading.
About Atherosclerotic Cardiovascular Disease
ASCVD is attributed to the buildup of fat deposits, which essentially clog up the heart's arteries. These deposits are called atheroma or plaque. Plaque is built up over time in the inner lining of the arteries, which limits the blood and oxygen flow and supply to the heart. The disease can occur in any artery, but most commonly it occurs in the aorta, the artery that receives blood directly from the heart. ASCVD can lead to angina pectoris, heart attack, and cardiac arrest.
About Bempedoic Acid
Bempedoic acid is a convenient, complementary, consistent, once-daily, oral LDL-C lowering drug that significantly reduces elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies. Bempedoic acid, a first-in-class, non-statin, targeted therapy, works in the liver to block cholesterol biosynthesis. Completed Phase-1 and Phase-2 studies conducted in about 1,300 patients, with more than 800 patients treated with bempedoic acid having produced LDL-C lowering results of up to 30% as monotherapy, 50% in combination with ezetimibe and an incremental 20+% when added to stable statin therapy.
About Esperion Therapeutics, Inc.
Founded in 2008 and headquartered in Ann Arbor, Michigan, Esperion Therapeutics is the Lipid Management company that specializes in developing and commercializing non-statin, convenient, complementary, consistent, once-daily, oral therapies for the treatment of patients with elevated LDL-C.
Stock Performance Snapshot
May 3, 2018 - At Thursday's closing bell, Esperion Therapeutics' stock declined 19.28%, ending the trading session at $36.93.
Volume traded for the day: 14.85 million shares, which was above the 3-month average volume of 834.27 thousand shares.
After yesterday's close, Esperion Therapeutics' market cap was at $945.41 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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