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FDA Updates Labels of Esperion's (ESPR) Cholesterol-Lowering Drugs
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Shares of Esperion (ESPR - Free Report) were up 4% in after-market trading on Dec 13 after it announced that the FDA updated the labels on its LDL-cholesterol (LDL-C) lowering drugs Nexletol and Nexlizet.
The updated labeling in both of Esperion’s drugs adds the treatment of primary hyperlipidemia (high cholesterol) as a qualifier for existing approved populations while removing the statin limitation. These updates to the Nexletol and Nexlizet labels are effective immediately.
The FDA also removed the prior limitation of use, stating ‘the effect of Nexlizet or Nexletol on cardiovascular morbidity and mortality has not been determined.’
Year to date, shares of Esperion have plunged 75.8% compared to the industry’s 5.9% fall.
Image Source: Zacks Investment Research
In June, Esperion submitted supplemental new drug applications (sNDAs) with the FDA seeking label expansion for Nexletol and Nexlizet in cardiovascular (CV) risk-reduction indications. A final decision is expected by Mar 31, 2024.
In Europe, Nexletol is available as Nilemdo and Nexlizet is marketed as Nustendi. Esperion has an agreement with Daiichi Sankyo Europe for commercialization rights to Nilemdo and Nustendi in Europe.
In June, regulatory filings were also submitted to the European Medicines Agency (EMA) seeking label expansion for Nilemdo and Nustendi in CV risk reduction indications. A final decision is expected in first-half 2024.
The submissions with the FDA and EMA are based on data from the phase III CLEAR Cardiovascular Outcomes study wherein treatment with bempedoic acid (which is contained in Nexletol and Nexlizet) can significantly reduce CV risk across a range of primary and second endpoints.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 9.3% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.14. Shares of NVO have surged 46.2% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, Ocuphire’s estimates for 2023 have improved from a loss of 60 cents per share to 42 cents. During the same period, loss estimates per share for 2024 have narrowed from 85 cents to 57 cents. Shares of Ocuphire have lost 23.8% in the year-to-date period.
Ocuphire’s earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an earnings surprise of 59.28%. In the last reported quarter, Ocuphire’s earnings beat estimates by 178.13%.
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FDA Updates Labels of Esperion's (ESPR) Cholesterol-Lowering Drugs
Shares of Esperion (ESPR - Free Report) were up 4% in after-market trading on Dec 13 after it announced that the FDA updated the labels on its LDL-cholesterol (LDL-C) lowering drugs Nexletol and Nexlizet.
The updated labeling in both of Esperion’s drugs adds the treatment of primary hyperlipidemia (high cholesterol) as a qualifier for existing approved populations while removing the statin limitation. These updates to the Nexletol and Nexlizet labels are effective immediately.
The FDA also removed the prior limitation of use, stating ‘the effect of Nexlizet or Nexletol on cardiovascular morbidity and mortality has not been determined.’
Year to date, shares of Esperion have plunged 75.8% compared to the industry’s 5.9% fall.
Image Source: Zacks Investment Research
In June, Esperion submitted supplemental new drug applications (sNDAs) with the FDA seeking label expansion for Nexletol and Nexlizet in cardiovascular (CV) risk-reduction indications. A final decision is expected by Mar 31, 2024.
In Europe, Nexletol is available as Nilemdo and Nexlizet is marketed as Nustendi. Esperion has an agreement with Daiichi Sankyo Europe for commercialization rights to Nilemdo and Nustendi in Europe.
In June, regulatory filings were also submitted to the European Medicines Agency (EMA) seeking label expansion for Nilemdo and Nustendi in CV risk reduction indications. A final decision is expected in first-half 2024.
The submissions with the FDA and EMA are based on data from the phase III CLEAR Cardiovascular Outcomes study wherein treatment with bempedoic acid (which is contained in Nexletol and Nexlizet) can significantly reduce CV risk across a range of primary and second endpoints.
Esperion Therapeutics, Inc. Price
Esperion Therapeutics, Inc. price | Esperion Therapeutics, Inc. Quote
Zacks Rank & Key Picks
Esperion currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) , Novo Nordisk (NVO - Free Report) , and Ocuphire Pharma (OCUP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 9.3% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.14. Shares of NVO have surged 46.2% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, Ocuphire’s estimates for 2023 have improved from a loss of 60 cents per share to 42 cents. During the same period, loss estimates per share for 2024 have narrowed from 85 cents to 57 cents. Shares of Ocuphire have lost 23.8% in the year-to-date period.
Ocuphire’s earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an earnings surprise of 59.28%. In the last reported quarter, Ocuphire’s earnings beat estimates by 178.13%.