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Details:
Winrevair (sotatercept-csrk) is the first activin signaling inhibitor therapy, which is approved for the treatment of adults with pulmonary arterial hypertension.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Winrevair
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2024
Details:
MK-7962 (sotatercept) is a potential first-in-class activin signaling inhibitor biologic being studied for the treatment of adult patients with pulmonary arterial hypertension.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MK-7962
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2023
Details:
MK-7962 (sotatercept), is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the transforming growth factor-beta protein superfamily involved in remodeling and regeneration of a variety of different tissues like vasculature and fibrosis.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MK-7962
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2023
Details:
Sotatercept,is an investigational, potential first-in-class activin receptor type IIA-Fc fusion protein demonstrated significant improvement in exercise capacity and key secondary outcome measures compared to placebo when added to background therapy.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MK-7962
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2022
Details:
Through the successful completion of the acquisition of Acceleron Pharma, Merck would be growing its cardiovascular portfolio and pipeline, including Acceleron’s lead therapeutic candidate, sotatercept, has a novel mechanism of action with the potential to improve short-term.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Merck
Deal Size: $11,500.0 million Upfront Cash: $11,500.0 million
Deal Type: Acquisition November 19, 2021
Details:
Under the terms of the acquisition agreement, Merck will acquire all outstanding shares of Acceleron including its pipeline having lead therapeutic candidate, sotatercept, in Phase 3 trials as add-on to current standard of care for the treatment of PAH.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: $11,500.0 million Upfront Cash: $11,500.0 million
Deal Type: Acquisition September 30, 2021
Details:
The SPECTRA Phase 2 trial is a single arm, open-label, multi-center exploratory study to determine the eects of sotatercept plus standard of care in adults with WHO functional class III PAH.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2021
Details:
A total of 106 patients were randomized in a 3:3:4 ratio to receive placebo, sotatercept 0.3 mg/kg, or sotatercept 0.7 mg/kg subcutaneously every three weeks on top of standard-of-care therapies.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2021
Details:
The PULSAR Phase 2 trial evaluating sotatercept in combination with approved PAH-specific medicines in patients with PAH achieved its primary endpoint of improvement in pulmonary vascular resistance and its key secondary endpoint of improvement in 6-minute walk distance.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2021
Details:
Results show patients treated with sotatercept experienced improvements in hemodynamic and functional endpoints compared with placebo.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2021
Details:
Acceleron is currently advancing a Phase 3 development plan for sotatercept, beginning with the registrational trial known as STELLAR expected to initiate by the end of this year.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
Echocardiography data obtained during the PULSAR trial showed that patients on stable background PAH-specific therapies treated with sotatercept experienced improvement in a measure of cardiopulmonary function known as right ventricular-pulmonary arterial (RV-PA) coupling.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Treatment with sotatercept in first set of patients in the ongoing SPECTRA Phase 2 trial was associated with substantial improvements in hemodynamics, exercise tolerance and exercise capacity at week 24.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Product Name: ACE-011
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
The presentation of the PULSAR trial echocardiography data, which earned the AHA’s “Cardiopulmonary Best Abstract” award, will focus on sotatercept’s effects on cardiac right ventricular function in conjunction with pulmonary arterial pressure in patients with PAH.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ACE-011
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Acceleron intends to use net proceeds to conduct clinical trials of Sotatercept and associated activities in connection with its therapeutic candidates in its pulmonary programs to launch and commercialization of sotatercept.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $450.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 30, 2020
Details:
Conference call and webcast will review the topline results of the PULSAR Phase 2 trial of sotatercept in patients with pulmonary arterial hypertension (PAH). Data from the PULSAR trial will have been presented during a virtual session of the American Thoracic Society 2020.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Preclinical research of murine version of sotatercept reveals significant role of key TGF-beta superfamily proteins, including activin and growth differentiation factor ligands, in pulmonary vascular disease.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Sotatercept is the first therapeutic to receive PRIME designation in pulmonary arterial hypertension since the EMA established the program in 2016.
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2020
Details:
The PULSAR trial achieved its primary endpoint: a statistically significant reduction in pulmonary vascular resistance
Lead Product(s): Sotatercept
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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