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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): Luspatercept

            Therapeutic Area: Hematology Product Name: Reblozyl

            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 29, 2020

            Details:

            This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.

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            Lead Product(s): Tenapanor,Sevelamer Hydrochloride

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of patients to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care, showed the data analysis from NORMALIZE Phase 4 Study.

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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): Ferric Citrate

            Therapeutic Area: Hematology Product Name: Auryxia

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 10, 2020

            Details:

            The COMPASS trial was designed to investigate the efficacy and safety of dosing ferric citrate twice-daily as compared to the current U.S. FDA approved dosing of ferric citrate three times daily in adult patients with chronic kidney disease (CKD) not on dialysis.

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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:

            The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.

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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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