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Find Hematology Drugs in Phase III Clinical Development in UNITED STATES

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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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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: Undisclosed

            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 June 12, 2020

            Details:

            71% of pegcetacoplan-treated patients achieved LDH normalization vs. 15% of eculizumab-treated patients. Detailed results from positive head-to-head Phase 3 PEGASUS study in patients with paroxysmal nocturnal hemoglobinuria presented at the European Hematology Association.

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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 June 11, 2020

            Details:

            In this previously presented post-hoc analysis, 32 patients received TAVALISSE as a second-line therapy, and 78% achieved ≥1 platelet count of ≥50,000/µL. Adverse events were manageable and consistent with those previously reported with fostamatinib.

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            Lead Product(s): Narsoplimab

            Therapeutic Area: Hematology Product Name: Undisclosed

            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 June 11, 2020

            Details:

            The results of Omeros’ pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy will be shared as an oral presentation at the virtual edition of the 25th annual European Hematology Association Congress.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology 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 08, 2020

            Details:

            Roxadustat demonstrates non-inferiority to darbepoetin alfa in achievement of Hb correction in DOLOMITES Phase 3 study of anemia in non-dialysis dependent patients with chronic kidney disease.

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            Lead Product(s): Pegcetacoplan

            Therapeutic Area: Hematology Product Name: Undisclosed

            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 May 21, 2020

            Details:

            The NDA submission is backed by results from Apellis Phase 3 PEGASUS study. Based on feedback from the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting to discuss the registration strategy for pegcetacoplan.

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            Lead Product(s): Ferric Citrate

            Therapeutic Area: Hematology 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 May 18, 2020

            Details:

            The NDA is based on JT and Torii's Phase 3 clinical study and other clinical studies in adult patients with IDA in Japan.

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            Lead Product(s): Narsoplimab

            Therapeutic Area: Hematology Product Name: Undisclosed

            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 May 14, 2020

            Details:

            The presentation will highlight Omeros's study entitled, Narsoplimab (OMS721) for the Treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy.

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