Esperion (ESPR) to Expand Nilemdo and Nustendi Label in Europe
Esperion ESPR announced the submission of a type II(a) variation application for label expansion of Nilemdo and Nustendi in Europe. This application seeks European Medicines Agency’s (EMA) approval for the use of both drugs in reducing cardiovascular risk among patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD).
Management anticipates a potential approval for the label expansion in the first half of 2024.
Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) are oral non-statin medicines approved in Europe for adults with ASCVD who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
The EMA filing is based on positive data from the phase III CLEAR study, which evaluated the efficiency of bempedoic acid in reducing cardiovascular (CV) risk. Data from the study showed that bempedoic acid demonstrated CV risk reductions and significantly reduced the possibility of heart attack and coronary revascularization as compared with a placebo.
Shares of Esperion have nosedived 77.8% year to date compared with the industry’s 3.3% decline.
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Nilemdo and Nustendi are commercialized under the brand names Nexletol and Nexlizet tablets, respectively, in the United States. Earlier this month, the company also submitted supplemental new drug applications (sNDAs) to the FDA for Nexletol and Nexlizet.
The sNDAs are seeking to expand the abovementioned drugs’ indications to include CV risk reduction. A final decision on these applications is also expected by the first half of 2024.
The candidate bempedoic acid (found in Nilemdo and Nustendi) now becomes the first therapy beyond statins to have demonstrated effective reduction of LDL-C levels and hard ischemic events in CV patients. It will not only benefit patients with ASCVD but also the primary prevention patients with limited treatment options at disposal.
Esperion has a licensing agreement with Daiichi Sankyo Europe, wherein the latter has exclusive rights to commercialize Nilemdo and Nustendi in Europe.
If the new indications get approved by the regulatory agency, Daiichi Sankyo Europe will continue to market the drugs in the continent.
Esperion Therapeutics, Inc. Price and Consensus
Esperion Therapeutics, Inc. price-consensus-chart | Esperion Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Novartis NVS, Akero Therapeutics AKRO and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis’ 2023 earnings has gone up from $6.56 per share to $6.74 in the past 90 days. Shares of Novartis have risen 8.5% year to date.
NVS’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 5.15%.
The consensus estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 17.1% year to date.
AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.49 per share to a loss of $2.05 for 2023 in the past 90 days. Shares of the company have rallied 2.2% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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