Cardiology/Vascular Diseases

Pfizer Inc

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United States

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Premier ProvideGx Program Partners with Pfizer

Lead Product(s): Ibutilide

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Premier Intermediates Pvt.Ltd.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership February 19, 2020

Details:

Premier’s ProvideGx program identifies safe, high-quality supply sources for drugs that are or may be at risk of being added to the national drug shortage list.

Vectura Ltd

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United Kingdom

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Vectura Signs Agreement with Aerami Therapeutics Inc

Lead Product(s): Imatinib

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Aerami

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement June 08, 2020

Details:

Aerami will be responsible for the overall development and commercialisation of inhaled imatinib, with Vectura providing development services expertise and a license to its FOX® mesh nebuliser technology.

Nyrada

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Australia

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Nyrada Reveals Encouraging Cholesterol-Lowering Drug Study Results

Lead Product(s): NYX-PCSK9i

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Preclinical Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

According to pre-clinical results, the cells showed an increase in LDL receptor levels and demonstrated equivalency to marketed monoclonal PCSK9 antibody drugs, evolocumab and alirocumab.

Celixir

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United Kingdom

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Celixir Provides Update on Ongoing Clinical Programme with Lead Therapeutic Candidate CLXR-001

Lead Product(s): iMP cells

Therapeutic Area: Cardiology/Vascular Diseases Product Name: CLXR-001

Highest Development Status: Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 06, 2020

Details:

CLXR-001 is a novel formulation that allows for rapid point-of-care use of Celixir’s novel allogeneic (off-the-shelf) iMP cells without the requirement for a cell culture laboratory.

scPharmaceuticals

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United States

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scPharmaceuticals Announces FUROSCIX® NDA Resubmission

Lead Product(s): Furosemide

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Furoscix

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2020

Details:

scPharmaceuticals has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of FUROSCIX® (subcutaneous furosemide) for the treatment of congestion in patients with heart failure.

BioCardia

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United States

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BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial Ischemia

Lead Product(s): CardiAMP cell therapy

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 01, 2020

Details:

The CardiAMP CMI Trial is studying CardiAMP cell therapy, an autologous cell therapy formulation designed to stimulate the body’s natural healing response for the treatment of refractory angina, estimated to impact between 600,000 and 1,800,000 patients in the United States.

Matinas BioPharma

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United States

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Matinas BioPharma Resumes Enrollment in the ENHANCE-IT and EnACT Clinical Trials

Lead Product(s): Omega-3 pentaenoic acid

Therapeutic Area: Cardiology/Vascular Diseases Product Name: MAT9001

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

Matinas BioPharma Holdings has commenced enrollment and started dosing patients in the ENHANCE-IT study and that it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda.

Mezzion Pharma Co Ltd

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Korea, Republic Of

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Mezzion Announces Submission of NDA for its Orphan Drug Udenafil

Lead Product(s): Udenafil

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 30, 2020

Details:

The NDA submission, which totals nearly 100,000 pages, is supported by data from more than 700 documents including more than 200 studies that Mezzion has completed during the last 2 decades since its founding in 2002.

Shionogi Inc

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United States

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Shionogi Signs New Contract with StemRIM Toward Investigator-initiated Clinical Study Implementation of S-005151

Lead Product(s): Redasemtide

Therapeutic Area: Cardiology/Vascular Diseases Product Name: S-005151

Highest Development Status: Phase I Product Type: Peptide

Partner/Sponsor/Collaborator: StemRIM

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 30, 2020

Details:

The companies have entered a licensing agreement for S-005151 [Generic name: Redasemtide] to conduct investigator-initiated clinical studies targeting new indications in the future.

Intra-Cellular Therapies

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United States

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Intra-Cellular Therapies Announces Positive Top-line Results from ITI-214 Phase I/II Study in Patients with Heart Failure

Lead Product(s): ITI214

Therapeutic Area: Cardiology/Vascular Diseases Product Name: ITI-214

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

Details:

In this study, ITI-214 improved cardiac output by increasing heart contractility and decreasing vascular resistance.

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Product Type

Development Status

Pfizer Inc

Premier ProvideGx Program Partners with Pfizer

Vectura Ltd

Vectura Signs Agreement with Aerami Therapeutics Inc

Nyrada

Nyrada Reveals Encouraging Cholesterol-Lowering Drug Study Results

Celixir

Celixir Provides Update on Ongoing Clinical Programme with Lead Therapeutic Candidate CLXR-001

scPharmaceuticals

scPharmaceuticals Announces FUROSCIX® NDA Resubmission

BioCardia

BioCardia Announces Activation of Pivotal Trial Studying CardiAMP Cell Therapy Trial to Treat Chronic Myocardial Ischemia

Matinas BioPharma

Matinas BioPharma Resumes Enrollment in the ENHANCE-IT and EnACT Clinical Trials

Mezzion Pharma Co Ltd

Mezzion Announces Submission of NDA for its Orphan Drug Udenafil

Shionogi Inc

Shionogi Signs New Contract with StemRIM Toward Investigator-initiated Clinical Study Implementation of S-005151

Intra-Cellular Therapies

Intra-Cellular Therapies Announces Positive Top-line Results from ITI-214 Phase I/II Study in Patients with Heart Failure