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) has announced the launch of the CLEAR ACS trial, aimed at evaluating the efficacy of NEXLIZET in reducing LDL-C in patients post-acute coronary syndrome (ACS). This 24-week study will recruit 500 patients, assessing the drug's safety and effectiveness in diverse, high-risk populations often underrepresented in clinical trials. The findings could significantly impact treatment protocols for LDL-C management. Key endpoints include changes in LDL-C levels and cardiovascular outcomes.
Esperion (NASDAQ: ESPR) plans to report its first-quarter 2022 financial results on May 3, 2022, before U.S. markets open. Following the announcement, management will discuss the results and business progress during a conference call at 8:00 a.m. ET. Interested parties can join the call by dialing (877) 831-3840 or (253) 237-1184, with an access code of 1489326. A live audio webcast will also be available on the Esperion website, along with a replay accessible two hours after the call.
Esperion has released positive pooled Phase 3 data demonstrating significant LDL-C reductions. Bempedoic acid monotherapy resulted in a 26.5% reduction versus placebo, while a fixed-dose combination of bempedoic acid and ezetimibe achieved a 39.2% reduction, both statistically significant (p<0.001). The study involved 427 participants, emphasizing lipid management for statin-intolerant patients. Ongoing trials like CLEAR Outcomes aim to enhance understanding of bempedoic acid’s efficacy. The findings suggest promise for patients unable to tolerate statins, marking a potential shift in cholesterol management strategies.
Esperion presented significant clinical analyses for NEXLETOL (bempedoic acid) at the ACC.22 conference, highlighting its efficacy in lowering LDL-C in patients with renal impairment and hypertension. The analyses, covering over 3,600 patients, demonstrated significant LDL-C reductions (p<0.0001) across various patient groups. NEXLETOL is the first oral, once-daily non-statin LDL-C-lowering medication approved by the FDA in nearly two decades, supporting its use for adults with established cardiovascular disease or heterozygous familial hypercholesterolemia who need additional LDL-C lowering.
Esperion (NASDAQ: ESPR) announced that President and CEO Sheldon Koenig will present at the 21st Annual Needham Healthcare Conference on April 12, 2022. The event will feature a virtual fireside chat and 1:1 meetings, starting at 9:30 a.m. ET. Interested parties can access live audio webcasts on the investor relations section of the Esperion website. Replays will be available for 90 days following the event. Esperion is focused on lipid management, developing innovative medicines to lower cholesterol.
Esperion (NASDAQ: ESPR) will have its Chief Medical Officer, Dr. JoAnne Foody, participate in a Cardiometabolic/NASH panel at the Cowen 42nd Annual Healthcare Conference on March 8, 2022. This event will include one-on-one investor meetings and will be held in a virtual format starting at 12:50 p.m. ET. Live webcasts will be available on the company's investor relations website, with replays archived for 90 days post-event. Esperion focuses on lipid management and aims to provide innovative treatments for cholesterol reduction.
Esperion reported a strong performance for Q4 2021, with U.S. net product revenue for NEXLETOL and NEXLIZET growing 12% sequentially to $12.2 million, a 200% increase for the full year. Prescriptions rose by 9%, reaching approximately 70,000 patients. The company strengthened its capital position with $209 million from equity financing, extending its cash runway to support the upcoming CLEAR Outcomes trial results.
Esperion anticipates significant operating expenses in 2022, with R&D expenses projected between $100 million to $110 million.
Esperion (NASDAQ: ESPR) will announce its fourth quarter and full year 2021 financial results on February 22, 2022, before the U.S. market opens. The company will conduct a webcast and conference call at 8:00 a.m. ET to discuss the results and business progress, accessible via phone or on their website. Esperion focuses on innovating cholesterol-lowering medications, including NEXLETOL® and NEXLIZET® tablets, aimed primarily at patients inadequately served by existing treatments.
Esperion (NASDAQ: ESPR) granted stock options and restricted stock units (RSUs) to four new employees on January 27, 2022. Notably, Benjamin Looker, the new General Counsel, received options to purchase 100,450 shares at an exercise price of $3.65 per share and 70,800 RSUs. The RSUs will vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly. This granting aligns with the 2017 Inducement Equity Incentive Plan, aimed at attracting new talent to the company, which focuses on innovative cholesterol-lowering therapies.
Esperion (NASDAQ: ESPR) announced preliminary Q4 2021 net U.S. product revenue estimated between $12.0 and $12.5 million. The company maintains its full-year 2022 operating expense guidance at $220 million to $240 million, inclusive of $25 million in non-cash stock-compensation expenses. A significant milestone is the ongoing CLEAR Outcomes Trial, achieving 85% major adverse cardiac events (MACE) accumulation by December 2021. The company will present at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022.
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