Welcome to our dedicated page for Esperion Therapeutics news (Ticker: ESPR), a resource for investors and traders seeking the latest updates and insights on Esperion Therapeutics stock.
Esperion Therapeutics, Inc. (NASDAQ: ESPR) is a leading pharmaceutical company specializing in the development and commercialization of innovative, first-in-class, oral therapies aimed at lowering low-density lipoprotein cholesterol (LDL-C). The company's flagship product, ETC-1002, is a potent inhibitor of ATP citrate lyase, an enzyme integral to the cholesterol biosynthesis pathway. This pathway also includes HMG-CoA reductase, the enzyme targeted by statins.
Esperion has made significant progress with ETC-1002, completing Phase 1 and Phase 2 clinical trials, and is set to initiate Phase 3 trials. The company's product lineup includes NEXLETOL and NEXLIZET, both of which are oral, once-daily, non-statin medications designed to tackle elevated LDL-C levels. These drugs have recently received expanded FDA approval for cardiovascular risk reduction and are indicated for both primary and secondary prevention patients.
In recent news, Esperion announced that both NEXLETOL and NEXLIZET have received broad new label expansions. These labels now cover cardiovascular risk reduction and expanded LDL-C lowering, either alone or in combination with statins. This approval allows over 70 million patients to access these life-saving drugs, positioning them as the non-statin drugs of choice for cardiovascular risk management.
Esperion is also ramping up its marketing and promotional efforts, enhancing patient support programs, and working with payers to improve patient access. The company is committed to breaking barriers in cardiovascular care and continues to focus on underserved populations, including women and Hispanic/Latinx patients, as demonstrated by their recent CLEAR Outcomes trial.
The company's forward-looking strategy includes ongoing clinical development, financial management, and expansion into new markets. Esperion's dedication to transforming cardiovascular care is evident in its robust pipeline and strategic initiatives aimed at addressing critical unmet medical needs.
Esperion (NASDAQ: ESPR) announced its participation in the ESC Congress 2020, presenting pooled analyses from four Phase 3 trials and long-term data on NEXLETOL (bempedoic acid). The presentations will cover its effects on uric acid in patients and the drug's long-term safety and efficacy. NEXLETOL was recently approved by the FDA and European Commission, with European availability expected by Q4 2020. This medicine represents a significant advancement as a non-statin LDL-C lowering option for patients at high risk of cardiovascular events.
On August 19, 2020, Esperion (NASDAQ: ESPR) granted 25,566 restricted stock units (RSUs) to 28 new employees under its 2017 Inducement Equity Incentive Plan. This plan is designed to attract new talent by granting equity awards to individuals not previously associated with the company. The RSUs vest over a four-year period, with 25% vesting on the one-year anniversary and the remaining 75% vesting quarterly. Esperion focuses on developing oral medications to lower LDL-C levels to combat cardiovascular disease, which affects over 96 million adults in the U.S.
Esperion (NASDAQ:ESPR) announced record-breaking financial results for Q2 2020, achieving total revenue of $212.2 million and $214.1 million for the first half of the year. Strong commercial traction was highlighted by over 80% commercial and 50% Medicare Part D formulary coverage for its products NEXLETOL® and NEXLIZET™. The company ended the second quarter with a robust cash position of over $300 million. Esperion also reported a net income of $124.6 million for the quarter, compared to a net loss in the same quarter the previous year.
Esperion (NASDAQ: ESPR) will report its second quarter 2020 financial results on August 10, 2020. Following the release, a conference call will be held at 4:30 p.m. ET to discuss the results and business progress. Esperion is focused on developing oral medications to lower LDL-C, addressing the significant health challenge posed by high cholesterol levels. Approximately 96 million adult Americans suffer from high LDL-C, with many unable to reach target levels using current therapies. The company aims to significantly impact cardiovascular health through its innovations.
Esperion (NASDAQ: ESPR) announced a publication in JAMA Cardiology detailing a pooled efficacy analysis from four Phase 3 studies of NEXLETOL, an oral LDL-cholesterol lowering medication. The studies involved 3,623 patients and demonstrated that NEXLETOL, when added to statin therapy, significantly lowered LDL-C by 18% versus placebo, and by 24% in statin-intolerant patients. The drug is intended for those with familial hypercholesterolemia or established cardiovascular disease needing additional LDL-C reduction. The safety profile showed similar adverse event rates between NEXLETOL and placebo.
Esperion (NASDAQ: ESPR) announced a $150 million milestone payment from Daiichi Sankyo Europe (DSE), which will be received this month due to the transfer of Marketing Authorization Approvals (MAAs) for NILEMDO and NUSTENDI. This agreement allows DSE to commercialize the drugs in Europe. With this payment, Esperion will have received $300 million in total milestone payments. Additionally, Esperion is conducting the CLEAR Cardiovascular Outcomes Trial to assess the impact of bempedoic acid on cardiovascular health for patients unable to tolerate statins.
Esperion (NASDAQ: ESPR) presented a pooled analysis from four Phase 3 clinical studies of NEXLETOL at the American Diabetes Association's 80th Scientific Sessions. The study revealed significant reductions in LDL cholesterol and other cholesterol markers among patients with diabetes, prediabetes, and normoglycemia. NEXLETOL also lowered hemoglobin A1c by 0.19%. The safety profile was consistent across all glycemic status subgroups. This analysis supports the efficacy and safety of NEXLETOL, which is a first-in-class oral medication approved for LDL-C lowering.
Esperion (NASDAQ: ESPR) received notice that the Institute for Clinical and Economic Review (ICER) will assess non-statin medicines for hypercholesterolemia, including the cost-effectiveness of NEXLETOL, with a report expected by February 2021. The company has achieved over 70% commercial and 40% Medicare Part D formulary coverage for NEXLETOL, aiming for affordable access to its treatment. Esperion is committed to patient access and has initiated the CLEAR Cardiovascular Outcomes Trial to evaluate NEXLETOL’s effects on cardiovascular events in statin-averse patients.
Esperion (NASDAQ: ESPR) announced that its CEO, Tim M. Mayleben, will participate in an analyst-led fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 4:40 p.m. ET. The event will be available via a live audio webcast on Esperion's investor relations website, with a replay accessible for 90 days afterward. Esperion is dedicated to developing oral medicines focused on lowering LDL-C to combat cardiovascular diseases, which affect millions in the U.S. Due to the high prevalence of elevated LDL-C levels, the company aims to offer effective solutions to improve patient outcomes.
Esperion (NASDAQ: ESPR) announced the launch of NEXLIZETTM (bempedoic acid and ezetimibe), the first approved non-statin LDL-C lowering combination medicine, now available in U.S. pharmacies. The drug achieves a mean LDL-C reduction of 38% when added to statins, with minimal paperwork for healthcare providers. NEXLIZET aims to set a new standard for affordability with broad payer coverage and a low co-pay for eligible patients. The launch has been accelerated by one month in response to healthcare provider requests, emphasizing the urgent need for additional cholesterol-lowering options.