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Details:
AMG 423 (omecamtiv mecarbil) is a selective, small molecule cardiac myosin activator, designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole for the treatment of HFrEF.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 28, 2023
Details:
Omecamtiv mecarbil (AMG 423), is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 December 13, 2022
Details:
Preclinical research has shown that AMG 423 (omecamtiv mecarbil) increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 December 09, 2022
Details:
Cytokinetics is developing AMG 423 (omecamtiv mecarbil), a novel, selective cardiac myosin activator for the potential treatment for heart failure with reduced ejection fraction (HFrEF).
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 October 31, 2022
Details:
AMG 423 (Omecamtiv mecarbil), a small molecule cardiac myosin activator, first of novel class of myotropes1 designed to directly target contractile mechanism of heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 24, 2022
Details:
AMG 423 (omecamtiv mecarbil), an selective, small molecule cardiac myosin activator, first of novel class of myotropes1 designed to directly target contractile mechanisms of heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 17, 2022
Details:
AMG 423 (omecamtiv mecarbil) is an investigational, selective, small molecule cardiac myosin activator, first of a novel class of myotropes1 designed to directly target contractile mechanisms of heart, binding to and recruiting more cardiac myosin.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 17, 2022
Details:
AMG 423 (Omecamtiv mecarbil) stimulates cardiac myosin, a protein responsible for converting chemical energy into the mechanical force that results in contraction of the heart.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 16, 2022
Details:
No effect of Omecamtiv Mecarbil on exercise capacity in patients with heart failure with reduced ejection fraction in METEORIC-HF, Healthcare resource utilization and cost analysis from GALACTIC-HF demonstrate treatment with Omecamtiv Mecarbil led to 19% cost reduction.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 03, 2022
Details:
Omecamtiv mecarbil, a selective cardiac myosin activator for potential treatment for heart failure with reduced ejection fraction, stimulates cardiac myosin, a protein responsible for converting chemical energy into mechanical force that results in contraction of heart.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 24, 2022
Details:
No effect of AMG 423 (omecamtiv mecarbil), selective small molecule cardiac myosin activator on exercise capacity in patients for the treatment of heart failure with reduced ejection fraction.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 15, 2022
Details:
Royalty Pharma will provide Cytokinetics long-term capital to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten, and other general corporate purposes.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $450.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 07, 2022
Details:
Cytokinetics is developing omecamtiv mecarbil, a novel, selective cardiac myosin activator for the potential treatment for heart failure with reduced ejection fraction (HFrEF).
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $316.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 23, 2021
Details:
In addition, omecamtiv mecarbil has no adverse effect on heart rate, blood pressure, kidney function or blood potassium levels, suggesting it can be added without interfering with guideline-directed medical therapy.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 17, 2021
Details:
Pursuant to the terms of the Agreement, upon the effective date of Amgen’s termination, research, development and commercialization rights for compounds, including omecamtiv mecarbil and AMG 594, will transition to Cytokinetics.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cytokinetics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 23, 2020
Details:
The presentation showed that the drug, omecamtiv mecarbil, met its main trial combination goal of reducing the risk of heart related death or need for hospitalization and other urgent care.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Presentation of primary results from GALACTIC-HF the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil will be delivered in a Late Breaking Clinical Trial session, as well as five poster presentations at the AHA Scientific Sessions 2020.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 November 06, 2020
Details:
The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular (CV) death or heart failure events compared to placebo.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cytokinetics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
GALACTIC-HF evaluates whether omecamtiv mecarbil, dosed twice-daily added to standard of care can reduce risk of heart failure and cardiovascular death in patients with chronic heart failure and reduced ejection fraction.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 October 02, 2020
Details:
GALACTIC-HF the Phase 3 pivotal cardiovascular outcomes trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction, has been accepted for presentation in a virtual Late Breaking Clinical Trial session at the AHA Scientific Sessions 2020.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 September 17, 2020
Details:
Management will present an overview of the clinical development program for omecamtiv mecarbil featuring a review of GALACTIC-HF, a large, Phase 3, global, event-driven, cardiovascular outcomes trial of omecamtiv mecarbil.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 423
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 15, 2020
Details:
U.S. Food and Drug Administration has granted Amgen Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 08, 2020
Details:
Amgen and Cytokinetics have agreed to suspend enrollment in the Phase 1 study of AMG 594 to protect the safety and health of clinical study participants and healthcare professionals.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 14, 2020
Details:
Cytokinetics is conducting baseline characteristics from the cardiovascular outcomes trial of omecamtiv mecarbil, GALACTIC-HF.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 20, 2020
Details:
Data monitoring committee recommends Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure continue without changes.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 26, 2020
Details:
GALACTIC-HF is designed to evaluate whether treatment with omecamtiv mecarbil, dosed twice-daily in accordance with a pharmacokinetic-guided dose selection regimen, when added to standard of care.
Lead Product(s): Omecamtiv Mecarbil
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 06, 2020
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