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Esperion (NASDAQ: ESPR) announced its participation in upcoming June investor conferences. The company will present at the Jefferies Global Healthcare Conference in New York on June 5, 2024, at 4:30 p.m. ET, and the Goldman Sachs Healthcare Conference in Miami Beach on June 12, 2024, at 8:40 a.m. ET. Both events will be webcast live, with replays available on the Esperion website for 90 days. Esperion focuses on developing and commercializing innovative treatments for cardiovascular and cardiometabolic diseases, particularly targeting high cholesterol levels. The company aims to address the unmet health needs of millions of patients.
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.
