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Find Hematology Drugs in Phase III Clinical Development in UNITED STATES

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            Lead Product(s): Iodine-131 apamistamab

            Therapeutic Area: Hematology Product Name: Iomab-B

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Memorial Sloan Kettering Cancer Center

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 23, 2020

            Details:

            Apamistamab CD45 antibody is the basis for lead Phase 3 candidate Iomab-B for targeting conditioning prior to bone marrow transplant and next generation Iomab-ACT targeted conditioning program for CAR-T and Gene Therapies.

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            Lead Product(s): Narsoplimab

            Therapeutic Area: Hematology Product Name: OMS721

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2020

            Details:

            Narsoplimab targets mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA.

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            Lead Product(s): Fostamatinib Disodium

            Therapeutic Area: Hematology Product Name: Tavalisse

            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 November 17, 2020

            Details:

            Rigel received approval from the FDA for its Phase 3 clinical trial of fostamatinib disodium hexahydrate in warm autoimmune hemolytic anemia, to include proposed durable response measure for the primary efficacy endpoint and inclusion of additional secondary endpoints.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 05, 2020

            Details:

            Highlights include new analyses from the Phase 3 head-to-head PEGASUS study, which demonstrate a markedly greater proportion of patients achieved better hematological responses as well as quality-of-life improvements with pegcetacoplan versus eculizumab, a C5 inhibitor.

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            Lead Product(s): Narsoplimab

            Therapeutic Area: Hematology Product Name: OMS721

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

            Details:

            Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology Product Name: ASP1517

            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 October 22, 2020

            Details:

            Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined.

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            Lead Product(s): Narsoplimab

            Therapeutic Area: Hematology Product Name: OMS721

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 15, 2020

            Details:

            These updated data and analyses form the basis of regulatory review and product labeling. The BLA also includes data from the HSCT-TMA compassionate-use program, which are highly consistent with the clinical trial data.

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            Lead Product(s): Bentracimab

            Therapeutic Area: Hematology Product Name: PB2452

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 06, 2020

            Details:

            PhaseBio has expanded its pivotal Phase 3 REVERSE-IT trial for its lead product candidate bentracimab (formerly PB2452) into Canada, where the first patients outside of the United States have now been enrolled and dosed.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 15, 2020

            Details:

            The NDA and MAA submissions are based on results from the Phase 3 PEGASUS study, which met its primary endpoint, demonstrating the superiority of pegcetacoplan to eculizumab with a statistically significant improvement in hemoglobin levels at 16 weeks.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: APL-2

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 02, 2020

            Details:

            The study was designed to evaluate the efficacy of pegcetacoplan in 48 adult patients who are treatment-naïve, showed evidence of hemolysis (elevated LDH ≥ 1.5x ULN) and had hemoglobin levels that were less than the lower limit of normal at the time of their screening.

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