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Novartis' Cholesterol Drug Meets Primary Goals in Late-Stage Study
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Novartis (NVS - Free Report) announced positive data on the cholesterol drug Leqvio (inclisiran) from the late-stage V-MONO study.
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C). The drug is administered as a subcutaneous injection with an initial dose, another at three months, and then every six months.
The drug is approved in several countries, including the United States, EU, Japan and China.
Shares of Novartis have risen 18.8% year to date compared with the industry’s growth of 26.9%.
Image Source: Zacks Investment Research
NVS’ Leqvio Meets Primary Endpoints
V-MONO is a six-month randomized, double-blind, placebo and active-comparator controlled phase III study to evaluate the efficacy of Leqvio as monotherapy in patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) who are not receiving lipid-lowering therapy.
Approximately 350 patients were enrolled in the study. These patients were randomized in a 2:1:1 ratio to inclisiran (n=174), ezetimibe (n=89) or placebo (n=87). The primary endpoints were the percent change in LDL-C from baseline to day 150 with Leqvio vis-à-vis placebo and ezetimibe.
The study met its primary endpoints, demonstrating the superiority of Leqvio monotherapy over both placebo and ezetimibe in LDL-C reduction.
The positive results reinforce Leqvio’s efficacy across the full spectrum of ASCVD.
Novartis plans to share the results with regulatory agencies, including the FDA.
Novartis’ Leqvio Development Program
Novartis continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention.
V-MONO is part of the 60,000-patient VictORION clinical trial program assessing Leqvio for primary and secondary ASCVD prevention. V-MONO is the first trial evaluating a small interfering RNA (siRNA) therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD.
With the successful spin-off of the Sandoz business in 2023, Novartis is now a pure-play innovative medicine company with a focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology.
NVS’ cardiovascular franchise includes the blockbuster drug Entresto, which is approved for adults who have symptomatic heart failure with reduced ejection fraction, among other indications.
The successful development of Leqvio for expanded patient populations should further strengthen Novartis’ cardiovascular franchise.
NVS obtained the global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) .
ALNY is a leader in RNAi therapeutics with four approved drugs.
NVS Signs Agreement With Lindy Biosciences
Novartis has also entered into a multi-target exclusive global licensing agreement and strategic collaboration with Lindy Biosciences, a biotechnology company specializing in innovative drug formulation and delivery technologies.
The collaboration is aimed at enabling high-concentration self-administered drug treatments, improving patient outcomes and compliance.
Per the terms, Novartis will have exclusive global rights across multiple biologic targets to Lindy Biosciences' microglassification technology. In exchange, Lindy Biosciences will receive an upfront payment of $20 million. It will also be eligible to receive up to $934 million in milestone payments plus tiered royalties.
Estimates for LLY’s 2024 earnings have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Eli Lilly’s shares have risen 62.8%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.7%.
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Novartis' Cholesterol Drug Meets Primary Goals in Late-Stage Study
Novartis (NVS - Free Report) announced positive data on the cholesterol drug Leqvio (inclisiran) from the late-stage V-MONO study.
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C). The drug is administered as a subcutaneous injection with an initial dose, another at three months, and then every six months.
The drug is approved in several countries, including the United States, EU, Japan and China.
Shares of Novartis have risen 18.8% year to date compared with the industry’s growth of 26.9%.
Image Source: Zacks Investment Research
NVS’ Leqvio Meets Primary Endpoints
V-MONO is a six-month randomized, double-blind, placebo and active-comparator controlled phase III study to evaluate the efficacy of Leqvio as monotherapy in patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) who are not receiving lipid-lowering therapy.
Approximately 350 patients were enrolled in the study. These patients were randomized in a 2:1:1 ratio to inclisiran (n=174), ezetimibe (n=89) or placebo (n=87). The primary endpoints were the percent change in LDL-C from baseline to day 150 with Leqvio vis-à-vis placebo and ezetimibe.
The study met its primary endpoints, demonstrating the superiority of Leqvio monotherapy over both placebo and ezetimibe in LDL-C reduction.
The positive results reinforce Leqvio’s efficacy across the full spectrum of ASCVD.
Novartis plans to share the results with regulatory agencies, including the FDA.
Novartis’ Leqvio Development Program
Novartis continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention.
V-MONO is part of the 60,000-patient VictORION clinical trial program assessing Leqvio for primary and secondary ASCVD prevention. V-MONO is the first trial evaluating a small interfering RNA (siRNA) therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD.
With the successful spin-off of the Sandoz business in 2023, Novartis is now a pure-play innovative medicine company with a focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology.
NVS’ cardiovascular franchise includes the blockbuster drug Entresto, which is approved for adults who have symptomatic heart failure with reduced ejection fraction, among other indications.
The successful development of Leqvio for expanded patient populations should further strengthen Novartis’ cardiovascular franchise.
NVS obtained the global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) .
ALNY is a leader in RNAi therapeutics with four approved drugs.
NVS Signs Agreement With Lindy Biosciences
Novartis has also entered into a multi-target exclusive global licensing agreement and strategic collaboration with Lindy Biosciences, a biotechnology company specializing in innovative drug formulation and delivery technologies.
The collaboration is aimed at enabling high-concentration self-administered drug treatments, improving patient outcomes and compliance.
Per the terms, Novartis will have exclusive global rights across multiple biologic targets to Lindy Biosciences' microglassification technology. In exchange, Lindy Biosciences will receive an upfront payment of $20 million. It will also be eligible to receive up to $934 million in milestone payments plus tiered royalties.
NVS’ Zacks Rank & Stocks to Consider
NVS currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the pharma/biotech industry are Eli Lilly (LLY - Free Report) and Exelixis (EXEL - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for LLY’s 2024 earnings have risen from $13.71 to $15.77 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $19.42 to $22.79 over the same timeframe. Year to date, Eli Lilly’s shares have risen 62.8%.
In the past 60 days, estimates for EXEL’s 2024 earnings per share have moved north to $1.79 from $1.39. Year to date, shares of EXEL have risen 7.7%.