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Esperion's (ESPR) Drugs Get EU Nod for Lowering Heart Risk
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Esperion Therapeutics, Inc. (ESPR - Free Report) and partner Daiichi Sankyo Europe GmbH announced that the European Commission (EC) has approved a label update for its drugs Nilemdo (bempedoic acid) and Nustendi for the treatment of hypercholesterolemia and to reduce the risk of adverse cardiovascular (CV) events.
Hypercholesterolemia indicates elevated levels of cholesterol in the blood.
Following the label expansion in Europe, Nilemdo and Nustendi became the first and only treatments for lowering low-density lipoprotein cholesterol (LDL-C), also known as bad cholesterol, approved for primary and secondary prevention of CV events.
Additionally, the updated labels support the use of Nilemdo and Nustendi either alone or in combination with statins.
Please note that Nustendi is a fixed-dose combination of bempedoic acid and ezetimibe.
The latest EC approval was based on positive data from the phase III CLEAR Outcomes study. Data from the same showed that treatment with Nilemdo and Nustendi led to a 13% reduction in the relative risk of major adverse CV events defined as a four-component composite of death from CV causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularization.
The decision from the EC was expected as the Committee for Medicinal Products for Human Use (CHMP) recommended the approval for the label update of both Nilemdo and Nustendi as treatments to reduce LDL-C and CV risk in March 2024.
Shares of Esperion have plunged 20.4% year to date compared with the industry’s decline of 7.4%.
Image Source: Zacks Investment Research
Per the company, despite receiving treatments with statins, around 80% of patients do not reach the guideline-recommended LDL-C goals and remain at higher risk of a heart attack or stroke.
Hence, with the updated label for Nilemdo and Nustendi that covers both primary and secondary prevention, statin-intolerant patients in need of additional treatment can be addressed better, improving CV care throughout Europe.
Nilemdo and Nustendi are marketed as Nexletol and Nexlizet, respectively, in the United States. The drugs are already approved for treating elevated LDL-C and CV risk reduction in the United States.
The FDA approved the label expansions for Nexletol tablets and Nexlizet tablets to include indications for CV risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients in March.
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 36.5%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 88.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 59.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same in the remaining three occasions, the average negative surprise being 54.43%.
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Esperion's (ESPR) Drugs Get EU Nod for Lowering Heart Risk
Esperion Therapeutics, Inc. (ESPR - Free Report) and partner Daiichi Sankyo Europe GmbH announced that the European Commission (EC) has approved a label update for its drugs Nilemdo (bempedoic acid) and Nustendi for the treatment of hypercholesterolemia and to reduce the risk of adverse cardiovascular (CV) events.
Hypercholesterolemia indicates elevated levels of cholesterol in the blood.
Following the label expansion in Europe, Nilemdo and Nustendi became the first and only treatments for lowering low-density lipoprotein cholesterol (LDL-C), also known as bad cholesterol, approved for primary and secondary prevention of CV events.
Additionally, the updated labels support the use of Nilemdo and Nustendi either alone or in combination with statins.
Please note that Nustendi is a fixed-dose combination of bempedoic acid and ezetimibe.
The latest EC approval was based on positive data from the phase III CLEAR Outcomes study. Data from the same showed that treatment with Nilemdo and Nustendi led to a 13% reduction in the relative risk of major adverse CV events defined as a four-component composite of death from CV causes, non-fatal myocardial infarction, non-fatal stroke or coronary revascularization.
The decision from the EC was expected as the Committee for Medicinal Products for Human Use (CHMP) recommended the approval for the label update of both Nilemdo and Nustendi as treatments to reduce LDL-C and CV risk in March 2024.
Shares of Esperion have plunged 20.4% year to date compared with the industry’s decline of 7.4%.
Image Source: Zacks Investment Research
Per the company, despite receiving treatments with statins, around 80% of patients do not reach the guideline-recommended LDL-C goals and remain at higher risk of a heart attack or stroke.
Hence, with the updated label for Nilemdo and Nustendi that covers both primary and secondary prevention, statin-intolerant patients in need of additional treatment can be addressed better, improving CV care throughout Europe.
Nilemdo and Nustendi are marketed as Nexletol and Nexlizet, respectively, in the United States. The drugs are already approved for treating elevated LDL-C and CV risk reduction in the United States.
The FDA approved the label expansions for Nexletol tablets and Nexlizet tablets to include indications for CV risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients in March.
Zacks Rank & Stocks to Consider
Esperion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) , Marinus Pharmaceuticals, Inc. (MRNS - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) , 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.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 36.5%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 88.2%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 59.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same in the remaining three occasions, the average negative surprise being 54.43%.