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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 (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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