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Novartis (NVS) Gets CHMP Positive Opinion for Entresto Approval
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Novartis (NVS - Free Report) announced that its cardiovascular drug Entresto (sacubitril/valsartan) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for a new indication in pediatric patients.
The CHMP recommended the drug’s approval to treat symptomatic chronic heart failure (HF) with left ventricular systolic dysfunction in pediatric patients aged 1 to 18 years or less.
The positive opinion is based on the data from the phase III PANORAMA-HF study and the extrapolation of adult HF data from the phase III PARADIGM-HF study to pediatric patients. The data suggested that Entresto provided similar clinically meaningful baseline reductions in the cardiac biomarker N-terminal pro-B-type natriuretic peptide in adult cardiac failure patients and pediatric patients aged 1 to 18 years with HF due to left ventricular systolic dysfunction. It allowed extrapolation of the demonstrated efficacy in adults to pediatric patients.
Shares of Novartis have gained 5.3% in the past year compared with the industry’s 4.8% growth.
Image Source: Zacks Investment Research
Entresto is approved in the EU since 2015 for treating symptomatic chronic HF with reduced ejection fraction in adults. It is also approved in the United States to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with chronic HF. The drug is also shown to treat childhood cardiac failure due to left ventricular systolic dysfunction since 2019.
Entresto is one of the leading drugs of Novartis and approval in additional patient populations will further boost its growth potential.
Other drugs of Novartis like Kesimpta, Zolgensma, Kisqali and Leqvio continue to fuel the company’s growth while offsetting the impact of generic competition for Gilenya. The recent launch of radioligand therapy, Pluvicto, showed a strong sales performance.
Earnings per share estimates for NVO have increased from $4.18 to $4.48 for 2023 and from $4.7 to $5.28 for 2024 in the past 60 days. The company's shares have surged 39.8% in the past year.
NVO's earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 3%.
Earnings per share estimates for INVA have increased from $1.04 to $1.37 for 2023 and from 52 cents to $1.25 for 2024 in the past 60 days. The company's shares have plunged 43.3% in the past year.
INVA's earnings beat estimates in one of the last four quarters and missed the mark in other three, the average negative surprise being 50.78%.
Earnings per share estimates for JNJ have increased from $10.27 to $10.50 for 2023 and from $10.70 to $10.94 for 2024 in the past 90 days.
JNJ's earnings beat estimates in each of the last four quarters, the average surprise being 2.94%. The company's shares have lost 12.2% in the past year.
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Novartis (NVS) Gets CHMP Positive Opinion for Entresto Approval
Novartis (NVS - Free Report) announced that its cardiovascular drug Entresto (sacubitril/valsartan) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for a new indication in pediatric patients.
The CHMP recommended the drug’s approval to treat symptomatic chronic heart failure (HF) with left ventricular systolic dysfunction in pediatric patients aged 1 to 18 years or less.
The positive opinion is based on the data from the phase III PANORAMA-HF study and the extrapolation of adult HF data from the phase III PARADIGM-HF study to pediatric patients. The data suggested that Entresto provided similar clinically meaningful baseline reductions in the cardiac biomarker N-terminal pro-B-type natriuretic peptide in adult cardiac failure patients and pediatric patients aged 1 to 18 years with HF due to left ventricular systolic dysfunction. It allowed extrapolation of the demonstrated efficacy in adults to pediatric patients.
Shares of Novartis have gained 5.3% in the past year compared with the industry’s 4.8% growth.
Image Source: Zacks Investment Research
Entresto is approved in the EU since 2015 for treating symptomatic chronic HF with reduced ejection fraction in adults. It is also approved in the United States to reduce the risk of cardiovascular death and hospitalization for HF in adult patients with chronic HF. The drug is also shown to treat childhood cardiac failure due to left ventricular systolic dysfunction since 2019.
Entresto is one of the leading drugs of Novartis and approval in additional patient populations will further boost its growth potential.
Other drugs of Novartis like Kesimpta, Zolgensma, Kisqali and Leqvio continue to fuel the company’s growth while offsetting the impact of generic competition for Gilenya. The recent launch of radioligand therapy, Pluvicto, showed a strong sales performance.
Novartis AG Price and Consensus
Novartis AG price-consensus-chart | Novartis AG Quote
Zacks Rank & Stocks to Consider
Currently, Novartis has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are Novo Nordisk (NVO - Free Report) , Innoviva (INVA - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Novo Nordisk sports a Zacks Rank #1 (Strong Buy), both Innoviva and Johnson & Johnson carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here.
Earnings per share estimates for NVO have increased from $4.18 to $4.48 for 2023 and from $4.7 to $5.28 for 2024 in the past 60 days. The company's shares have surged 39.8% in the past year.
NVO's earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 3%.
Earnings per share estimates for INVA have increased from $1.04 to $1.37 for 2023 and from 52 cents to $1.25 for 2024 in the past 60 days. The company's shares have plunged 43.3% in the past year.
INVA's earnings beat estimates in one of the last four quarters and missed the mark in other three, the average negative surprise being 50.78%.
Earnings per share estimates for JNJ have increased from $10.27 to $10.50 for 2023 and from $10.70 to $10.94 for 2024 in the past 90 days.
JNJ's earnings beat estimates in each of the last four quarters, the average surprise being 2.94%. The company's shares have lost 12.2% in the past year.