Welcome to our dedicated page for Esperion Therape news (Ticker: ESPR), a resource for investors and traders seeking the latest updates and insights on Esperion Therape stock.
Esperion Therapeutics Inc. (NASDAQ: ESPR) is a pharmaceutical company developing and commercializing oral cholesterol-lowering medications for patients with cardiovascular disease risk. The company's news flow reflects its position as a commercial-stage biotech navigating product launches, partnership expansions, and ongoing clinical evidence generation in the cardiovascular therapeutics market.
News from Esperion typically covers developments across several key areas. Regulatory and partnership milestones feature prominently as the company works with international partners to secure approvals and launch its products in new markets. These announcements track the global expansion of NEXLETOL and NEXLIZET beyond the United States through licensing relationships with regional pharmaceutical companies.
Clinical data and medical society presentations represent another significant news category. Esperion regularly presents analyses from the CLEAR Outcomes cardiovascular trial at major cardiology conferences, generating coverage when new data subsets demonstrate product benefits in specific patient populations or when medical guidelines incorporate bempedoic acid recommendations.
Financial updates including quarterly earnings reports and capital markets activities provide insight into the company's commercial progress and cash position. As a small-cap pharmaceutical company balancing commercial investment against revenue generation, these disclosures help investors track the trajectory toward sustainable profitability.
Pipeline developments appear periodically as Esperion advances preclinical candidates and evaluates new therapeutic applications for its scientific platform beyond cholesterol management. Bookmark this page to follow Esperion's progress across commercial execution, clinical evidence generation, and research advancement.
The European Commission has approved label updates for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid/ezetimibe) to treat hypercholesterolemia and reduce cardiovascular risk. This approval is based on the positive results from the CLEAR Outcomes trial, making these the first and only LDL-C lowering treatments indicated for both primary and secondary prevention of cardiovascular events.
NILEMDO can lower cholesterol by up to 28% when added to statin therapy, while NUSTENDI can reduce LDL-C by 38% in high-risk patients. The Phase 3 CLEAR Outcomes trial involved 13,970 patients and showed a 13% reduction in major adverse cardiovascular events.
Despite existing treatments, up to 80% of patients do not achieve guideline-recommended LDL-C levels, highlighting the need for new options like NILEMDO and NUSTENDI. The approval aims to provide healthcare professionals with better tools to manage cardiovascular risk and reassure patients of effective treatment options.
Esperion (ESPR) and Otsuka Pharmaceutical announced that their Phase 3 trial in Japan for bempedoic acid, a treatment for hypercholesterolemia, met its primary endpoint.
The study showed a 25.25% reduction in LDL cholesterol in the bempedoic acid group compared to a 3.46% reduction in the placebo group, achieving statistical significance (p<0.01).
No serious adverse events were reported, aligning with previous trials' safety and tolerability data.
Otsuka plans to submit a New Drug Application (NDA) in Japan in late 2024 based on these results.
Bempedoic acid is already marketed in the US and Europe for reducing cardiovascular risk and LDL cholesterol levels.
Esperion (NASDAQ: ESPR) has announced that the U.S. Patent and Trademark Office (USPTO) granted a five-year Patent Term Extension (PTE) for bempedoic acid, the key ingredient in NEXLETOL® and NEXLIZET® tablets. This extension extends U.S. Patent No. 7,335,799 through December 3, 2030. Bempedoic acid is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who cannot take recommended statin therapy. It is also used to lower LDL-C in adults with primary hyperlipidemia. The PTE will be included in the FDA's Orange Book, enhancing the market exclusivity of the drug. Important safety information includes the risk of hyperuricemia and tendon rupture, among other adverse reactions.
Esperion granted 62,300 RSUs to 16 new employees under the 2017 Inducement Equity Incentive Plan. The RSUs will vest over time based on employment. Esperion focuses on developing medicines for cardiovascular diseases, striving to improve patient outcomes. For more info, visit esperion.com.
Esperion reported impressive Q1 2024 financial results with total revenue growing 467% Y/Y to $137.7 million and U.S. net product revenue increasing 46% Y/Y to $24.8 million. They received FDA approval for label expansions of NEXLETOL and NEXLIZET, making them the first non-statins to prevent heart attacks. Positive CHMP opinion expected from European Commission in Q2 2024. Collaboration revenue surged by 1,448% Y/Y. The company's cash balance is strong at $226.6 million. Financial outlook remains positive for 2024 with operating expenses projected at $225-245 million.
Esperion (NASDAQ: ESPR) will participate in investor events in May, including JMP Securities’ Life Sciences Conference, Bank of America Securities’ Health Care Conference, and H.C. Wainwright’s BioConnect Investor Conference. Esperion focuses on developing medicines for cardiovascular and cardiometabolic diseases, aiming to improve outcomes for patients with high cholesterol.
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