Find Hematology Clinical Drug Pipeline Developments & Deals

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            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Nyvepria

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

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            Lead Product(s): Abelacimab

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: Anthos Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership June 11, 2020

            Details:

            The agreement furthers Anthos Therapeutics mission to develop Abelacimab for patients at risk of thrombotic events, which are currently underserved by conventional anti-coagulant therapies.

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            Lead Product(s): Vadadustat

            Therapeutic Area: Hematology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

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            Lead Product(s): OMS906

            Therapeutic Area: Hematology Product Name: OMS906

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2020

            Details:

            OMS906 is the company’s lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system’s alternative pathway.

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            Lead Product(s): BCX9930

            Therapeutic Area: Hematology Product Name: BCX9930

            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 August 31, 2020

            Details:

            BioCryst Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

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            Lead Product(s): LNP023

            Therapeutic Area: Hematology Product Name: LNP023

            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 August 29, 2020

            Details:

            Seven of ten patients discontinued eculizumab and remained on LNP023 as monotherapy, retaining hemoglobin (Hb) levels with no changes in biomarkers of disease activity and with no signs or symptoms of breakthrough hemolysis.

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            Lead Product(s): PLX-R18

            Therapeutic Area: Hematology Product Name: PLX-R18

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 19, 2020

            Details:

            The Phase I multi-center, open-label, 3 cohort dose-escalating study is evaluating the safety of intramuscular (IM) injections of PLX-R18 cells in 20 subjects, with incomplete hematopoietic recovery persisting for at least 3 months after HCT.

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            Lead Product(s): rNAPc2

            Therapeutic Area: Hematology Product Name: AB201

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 12, 2020

            Details:

            The FDA provided feedback for ARCA's clinical development plans for evaluating AB201 as a potential treatment for patients with severe COVID-19.

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            Lead Product(s): BCX9930

            Therapeutic Area: Hematology Product Name: BCX9930

            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 August 03, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

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            Lead Product(s): Ciraparantag

            Therapeutic Area: Hematology Product Name: PER977

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Norgine

            Deal Size: $290.0 million Upfront Cash: $30.0 million

            Deal Type: Licensing Agreement July 23, 2020

            Details:

            Ciraparantag is in development for use in patients treated with direct oral anticoagulants and low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery or due to life-threatening or uncontrolled bleeding.

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