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NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up
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NewAmsterdam Pharma Company N.V. (NAMS - Free Report) announced the dosing of the first patient and the initiation of the late-stage study TANDEM.
This phase III placebo-controlled, double-blind, four-arm, randomized study is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (FDC) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD risk equivalents requiring an additional lowering of low-density lipoprotein cholesterol (LDL-C).
Shares of this late-stage biopharmaceutical company have risen 11.9% on the news.
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments.
The primary endpoint of the TANDEM study is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy as well as placebo. Secondary objectives include evaluating the effect of the FDC on apolipoprotein B and non-high-density lipoprotein cholesterol. The study will also evaluate the safety and tolerability profile of the FDC.
NAMS targets enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl. The patients enrolled will be randomized to one of the following groups — placebo, 10 mg obicetrapib, 10mg ezetimibe, or obicetrapib 10mg and ezetimibe 10mg FDC tablet. All the patients in these groups will be dosed with a once-daily oral treatment for an 84-day period.
HeFH is an inherited genetic disorder that causes dangerously high cholesterol levels. Patients with ASCVD have established cardiovascular diseases characterized by the buildup of plaque in the arteries, including coronary artery stenosis, myocardial infarction or stroke.
While ezetimibe is a standard treatment for patients with elevated cholesterol at high risk of CVD, a significant proportion of these patients are unable to achieve the targeted LDL-C levels.
NewAmsterdam expects that by combining obicetrapib, if approved, with ezetimibe in a once-daily pill, this FDC therapy could meaningfully improve treatment options available to physicians for addressing elevated LDL-C, and lead to improved health outcome for millions of people living with increased risk for CVD globally.
Earlier, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins in the phase IIb ROSE study.
The combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe also demonstrated a 63% lowering of LDL-C from baseline in the phase II ROSE2 study.
NAMS is also conducting two phase III studies, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients. Enrollment was completed in the BROOKLYN study in April 2023 and in the BROADWAY study in July 2023. A phase III PREVAIL cardiovascular outcome trial was initiated in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.
Data from BROOKLYN and BROADWAY studies are expected in the third and fourth quarters of 2024, respectively.
Shares of the company have surged 79.5% in the past year against the industry’s decline of 3.7%.
Image Source: Zacks Investment Research
The successful development of obicetrapib will be a significant boost for NAMS, given the market potential.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA extended the approval of the cholesterol drug Praluent’s (alirocumab) label as an adjunct to diet and other low-density LDL-C lowering therapies to include pediatric patients aged eight and older with HeFH. It was already indicated for this indication for adults.
Regeneron records net product sales of Praluent in the United States, while partner Sanofi records net product sales of Praluent outside the United States and pays Regeneron a royalty on such sales.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents.
During the same period, the consensus estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, ADMA’s shares have surged 92.8%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the consensus estimate for the company’s 2025 loss per share is pegged at 6 cents.
FGEN beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 2.26%.
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NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up
NewAmsterdam Pharma Company N.V. (NAMS - Free Report) announced the dosing of the first patient and the initiation of the late-stage study TANDEM.
This phase III placebo-controlled, double-blind, four-arm, randomized study is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (FDC) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with Heterozygous Familial Hypercholesterolemia (HeFH), Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD risk equivalents requiring an additional lowering of low-density lipoprotein cholesterol (LDL-C).
Shares of this late-stage biopharmaceutical company have risen 11.9% on the news.
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments.
The primary endpoint of the TANDEM study is to evaluate the effect of 10mg obicetrapib and 10mg ezetimibe FDC on LDL-C levels, compared to both ezetimibe 10mg and obicetrapib 10mg monotherapy as well as placebo. Secondary objectives include evaluating the effect of the FDC on apolipoprotein B and non-high-density lipoprotein cholesterol. The study will also evaluate the safety and tolerability profile of the FDC.
NAMS targets enrolling approximately 400 patients on maximally tolerated lipid-modifying therapies with HeFH, ASCVD or ASCVD risk equivalents and who have a baseline LDL-C of at least 70 mg/Dl. The patients enrolled will be randomized to one of the following groups — placebo, 10 mg obicetrapib, 10mg ezetimibe, or obicetrapib 10mg and ezetimibe 10mg FDC tablet. All the patients in these groups will be dosed with a once-daily oral treatment for an 84-day period.
HeFH is an inherited genetic disorder that causes dangerously high cholesterol levels. Patients with ASCVD have established cardiovascular diseases characterized by the buildup of plaque in the arteries, including coronary artery stenosis, myocardial infarction or stroke.
While ezetimibe is a standard treatment for patients with elevated cholesterol at high risk of CVD, a significant proportion of these patients are unable to achieve the targeted LDL-C levels.
NewAmsterdam expects that by combining obicetrapib, if approved, with ezetimibe in a once-daily pill, this FDC therapy could meaningfully improve treatment options available to physicians for addressing elevated LDL-C, and lead to improved health outcome for millions of people living with increased risk for CVD globally.
Earlier, obicetrapib demonstrated a 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins in the phase IIb ROSE study.
The combination of a 10 mg dose of obicetrapib and a 10 mg dose of ezetimibe also demonstrated a 63% lowering of LDL-C from baseline in the phase II ROSE2 study.
NAMS is also conducting two phase III studies, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients. Enrollment was completed in the BROOKLYN study in April 2023 and in the BROADWAY study in July 2023. A phase III PREVAIL cardiovascular outcome trial was initiated in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization.
Data from BROOKLYN and BROADWAY studies are expected in the third and fourth quarters of 2024, respectively.
Shares of the company have surged 79.5% in the past year against the industry’s decline of 3.7%.
Image Source: Zacks Investment Research
The successful development of obicetrapib will be a significant boost for NAMS, given the market potential.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) recently announced that the FDA extended the approval of the cholesterol drug Praluent’s (alirocumab) label as an adjunct to diet and other low-density LDL-C lowering therapies to include pediatric patients aged eight and older with HeFH. It was already indicated for this indication for adults.
Regeneron records net product sales of Praluent in the United States, while partner Sanofi records net product sales of Praluent outside the United States and pays Regeneron a royalty on such sales.
Zacks Rank & Stock to Consider
NAMS currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) and FibroGen (FGEN - Free Report) . ADMA sports a Zacks Rank #1 (Strong Buy) and FGEN carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents.
During the same period, the consensus estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, ADMA’s shares have surged 92.8%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the consensus estimate for the company’s 2025 loss per share is pegged at 6 cents.
FGEN beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 2.26%.