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On Thursday, H.C. Wainwright maintained a Buy rating and a $16.00 stock price target for Esperion (NASDAQ:ESPR) Therapeutics (NASDAQ:ESPR). The firm's endorsement follows the announcement by Esperion's European partner, Daiichi Sankyo Europe (DSE) (TSE: 4568), regarding positive long-term data from the MILOS clinical trial.
The trial, which took place in Germany, evaluated the effectiveness of Esperion's products, NILEMDO (BDA) and NUSTENDI (BDA plus ezetimibe), on patients with primary hypercholesterolemia or mixed dyslipidemia.
The study involved 973 patients across 125 sites in Germany and demonstrated significant improvements in LDL-C levels over two years. At the end of the trial, a mean reduction in LDL-C levels from 3.1 mmol/L (121.4 mg/dL) at baseline to 2.0 mmol/L (77.2 mg/dL) was recorded.
This represents an average relative reduction of 30.3% in the overall population. Moreover, the percentage of patients meeting their LDL-C goals increased from 4.9% at baseline to 35.3% after two years, marking approximately a seven-fold increase.
The results were particularly notable among high-risk and very high-risk patients, with those achieving LDL-C goals rising from 5.6% to 32.5% and from 3.6% to 35.2%, respectively. The safety profile of BDA observed in the trial was consistent with previous findings from the CLEAR Outcomes trial, reinforcing the drug's safety in real-world settings.
The positive trial outcomes are expected to support the adoption of NILEMDO and NUSTENDI in Europe and potentially in other regions. Esperion's strategy for international expansion includes anticipated New Drug Application (NDA) filings in Japan by Otsuka Pharmaceutical, as well as in Canada, Australia, and Israel by the end of 2024.
The analyst from H.C. Wainwright highlighted the significance of the trial data in validating the therapeutic role of BDA, both as a standalone treatment and in combination with ezetimibe. The results are seen as a strong endorsement for the continued use and integration of Esperion's products in cholesterol management protocols across various markets.
In other recent news, Esperion Therapeutics Inc. has reported significant advancements in its operations. The company's Q2 earnings showcased robust growth, primarily driven by the successful commercialization of its cardiovascular therapies, NEXLETOL and NEXLIZET. The U.S. net product revenue saw a 39% increase, while total Q2 revenue reached $73.8 million, marking a 727% rise in collaboration revenue.
Results from the MILOS study, conducted by its European partner, Daiichi Sankyo Europe, revealed a substantial reduction in LDL-C levels among patients treated with bempedoic acid. The study followed 973 patients over two years, observing an average 30.3% reduction in LDL-C levels. The findings underscore the effectiveness of the treatments in real-world settings.
Esperion has also strengthened its financial position through a transaction that monetized the European royalty stream. The company is planning to file a new drug application in Japan through its partner, Otsuka Pharmaceutical.
Analysts anticipate that these partnerships in Europe and Japan will significantly contribute to Esperion's international expansion efforts. These are the latest developments in the company's operations, setting the stage for continuous growth within the cardiovascular market.
InvestingPro Insights
Esperion Therapeutics' (NASDAQ:ESPR) positive clinical trial results are reflected in some of its recent financial metrics. According to InvestingPro data, the company has shown impressive revenue growth, with a 215.98% increase in the last twelve months as of Q2 2024. This growth aligns with the potential market expansion for NILEMDO and NUSTENDI following the encouraging MILOS trial results.
InvestingPro Tips highlight that analysts anticipate sales growth in the current year, which could be driven by the increased adoption of Esperion's cholesterol management products in Europe and potential expansion into new markets. The company's significant return over the last week (10.98%) may be a response to the recent positive trial data announcement.
However, it is worth noting that despite the revenue growth, Esperion was not profitable over the last twelve months. This is not uncommon for biotech companies investing heavily in research and development. Investors interested in a more comprehensive analysis can find 5 additional InvestingPro Tips for Esperion Therapeutics on the InvestingPro platform.
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