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Details:

TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor. It is currently being investigated in adult patients with a history of atherosclerotic cardiovascular disease.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 09, 2024

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NewAmsterdam TA-8995 (obicetrapib), CETP inhibitor, in combination with Ezetimibe. It is being evaluated in Phase III clinical trial studies with patients for the treatment of Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease.


Lead Product(s): Obicetrapib,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 12, 2024

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The net proceeds will be used for the development of TA-8995 (obicetrapib). It is a selective cholesteryl ester transfer protein inhibitor that potently decreases (LDL-C) as well as increases (HDL-C), which is used for the treatment of atherosclerotic Cardiovascular disease.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $173.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering February 13, 2024

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TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor. It is currently being investigated in patients with early Alzheimer’s disease and at least one copy of the apolipoprotein E4 mutation.


Lead Product(s): Obicetrapib

Therapeutic Area: Neurology Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2023

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TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor having the potential for lowering LDL-C. It is currently being investigated in combination with ezetimibe as an adjunct to high-intensity statin therapy.


Lead Product(s): Obicetrapib

Therapeutic Area: Genetic Disease Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2023

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TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor having the potential for lowering LDL-C. It is currently being investigated in combination with ezetimibe as an adjunct to high-intensity statin therapy.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2023

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TA-8995 (obicetrapib) is a next-generation, oral, low-dose CETP inhibitor that NewAmsterdam is developing to potentially overcome the limitations of current LDL-lowering treatments.


Lead Product(s): Obicetrapib

Therapeutic Area: Genetic Disease Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2023

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Details:

TA-8995 (obicetrapib) is a next-generation, non statin, oral once-daily, low-dose CETP inhibitor having the potential for lowering LDL-C, if approved. It is currently being investigated in combination with ezetimibe as an adjunct to high-intensity statin therapy.


Lead Product(s): Obicetrapib,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 17, 2023

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Proceeds from this transaction will be used for three ongoing phase 3 trials, BROADWAY, BROOKLYN and PREVAIL, evaluating the effect of TA-8995 (obicetrapib) in patients with atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Frazier Healthcare Partners

Deal Size: $235.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement November 23, 2022

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Obicetrapib (TA-8995) is an oral, low-dose and once-daily CETP inhibitor, initially in development for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, both as a monotherapy and in a fixed-dose combination with ezetimibe.


Lead Product(s): Obicetrapib,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 05, 2022

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Details:

Emerging data reinforce combination lipid-lowering therapy as first-line strategy for very high-risk patients, supporting the development of TA-8995 (obicetrapib) as adjunct to high-intensity statins.


Lead Product(s): Obicetrapib

Therapeutic Area: Genetic Disease Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Frazier Lifesciences Acquisition Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 29, 2022

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Details:

Treatment with TA-8995 (obicetrapib) in patients on high-intensity statin therapy was observed to have statistically significant impact on LDL-C, as well as significant impacts on ApoB, non-HDL-C, HDL-C and Lp(a), additional key measures of cardiovascular disease risk.


Lead Product(s): Obicetrapib,Atorvastatin

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Frazier Healthcare Partners

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2022

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Details:

BROOKLYN evaluates TA-8995 (obicetrapib) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients requiring additional lowering of low-density lipoprotein cholesterol (LDL-C).


Lead Product(s): Obicetrapib

Therapeutic Area: Genetic Disease Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2022

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Details:

NewAmsterdam is investigating TA-8995 (obicetrapib), a next-generation oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C-lowering therapy for high-risk cardiovascular disease (“CVD”) patients.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Frazier Lifesciences Acquisition Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger July 25, 2022

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Details:

NewAmsterdam is investigating TA-8995 (obicetrapib), a next-generation oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C-lowering therapy for high-risk cardiovascular disease (“CVD”) patients.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Frazier Healthcare Partners

Deal Size: $235.0 million Upfront Cash: Undisclosed

Deal Type: Financing July 25, 2022

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Under the collaboration agreement, NewAmsterdam will retain all rights to commercialize obicetrapib in cardiovascular diseases, if approved, in the rest of the world, as well as rights to develop certain forms of TA-8995 for other diseases such as Alzheimer's disease.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Menarini

Deal Size: $1,061.5 million Upfront Cash: $121.0 million

Deal Type: Licensing Agreement June 28, 2022

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Details:

TA-8995 (Obicetrapib) is a next-generation oral, low-dose and once-daily CETP inhibitor in development for lowering low-density lipoprotein cholesterol (LDL-c) and preventing major adverse cardiovascular events.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2022

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Details:

TA-8995 (obicetrapib) is next-generation CETP inhibitor, initially in development for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, both as a monotherapy and in a fixed-dose combination with ezetimibe.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2022

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ROSE2 study evaluates obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor, in combination with ezetimibe, a cholesterol absorption inhibitor, in patients who are currently receiving high-intensity statin therapy.


Lead Product(s): Obicetrapib,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 05, 2022

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PREVAIL evaluates whether obicetrapib, a novel cholesteryl ester transfer protein inhibitor, lowers the risk of adverse cardiovascular outcomes in individuals with ASCVD, who are not adequately controlled despite maximally tolerated lipid-modifying therapies.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 01, 2022

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Details:

TA-8995 (obicetrapib) is a selective cholesteryl ester transfer protein inhibitor in development for lowering low-density lipoprotein cholesterol (LDL-c) and preventing major adverse cardiovascular events.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2022

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Phase 3 BROADWAY trial primary objective is to evaluate the effect of TA-8995 (obicetrapib), on LDL-c levels at day 84. Study evaluates obicetrapib, a novel cholesteryl ester transfer protein inhibitor, as an adjunct to diet and maximally tolerated lipid-lowering therapy.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2022

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Details:

Results of ROSE study demonstrated that patients on statin therapy who received 5mg of obicetrapib saw a reduction in LDL-c of 42% and patients who were part of the 10mg cohort experienced 51% reduction v/s baseline, while the placebo experienced 7% reduction v/s baseline.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 13, 2021

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Details:

ROSE was designed as a placebo-controlled, double-blind, randomized, Phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2021

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Funding will support initiation and finalization of Phase 3 development of obicetrapib, a potent ApoB and LDL-c lowering small molecule drug, intended for patients not well-controlled on statins.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: TA-8995

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Morningside Ventures

Deal Size: $196.0 million Upfront Cash: Undisclosed

Deal Type: Series A Financing January 14, 2021

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NewAmsterdam Pharma is currently working with the U.S. Food and Drug Administration (FDA) on a comprehensive Phase 3 clinical development program, including a cardiovascular outcome trial (CVOT) for obicetrapib.


Lead Product(s): Obicetrapib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 899

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: NewAmsterdam Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition August 25, 2020

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