Quotient Sciences Translational Pharmaceuticals Quotient Sciences Translational Pharmaceuticals

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Therapeutics"},{"orgOrder":0,"company":"BeyondSpring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BeyondSpring Presents New Clinical Evidence of Plinabulin Protection of Granulocyte-Monocyte Progenitor Stem Cells for the Prevention of Chemotherapy-Induced Neutropenia at the ESMO Congress 2022","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"BeyondSpring"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Granted FDA Rare Pediatric Disease Designation of Nomacopan for the Treatment of Pediatric HSCT-TMA","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Evive Biotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Aurobindo Unit, Evive Biotech Ink Licensing Pact to Commercialise CIN Treatment Product in US","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"INDIA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Aurobindo Pharma Limited"},{"orgOrder":0,"company":"BeyondSpring","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BeyondSpring Presents Positive Data with Plinabulin for the Prevention of Docetaxel-Induced Neutropenia in Patients with Non-Small Cell Lung Cancer and Breast Cancer at Three Medical Conferences","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"BeyondSpring"},{"orgOrder":0,"company":"Akebia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akebia Therapeutics Received Interim Response to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease from the FDA","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Akebia Therapeutics"},{"orgOrder":0,"company":"PhaseBio Pharmaceuticals","sponsor":"SFJ Pharmaceuticals","pharmaFlowCategory":"D","amount":"$120.0 million","upfrontCash":"Undisclosed","newsHeadline":"SFJ Pharmaceuticals Announces Closing of Transfer of Bentracimab Assets from PhaseBio Pharmaceuticals","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"PhaseBio Pharmaceuticals"},{"orgOrder":0,"company":"Cadrenal Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Cadrenal Therapeutics"},{"orgOrder":0,"company":"Akebia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akebia Receives Positive CHMP Opinion in Europe for Vafseo\u2122 (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Akebia Therapeutics"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Paulson Investment Company","pharmaFlowCategory":"D","amount":"$4.0 million","upfrontCash":"Undisclosed","newsHeadline":"Akari Therapeutics, Plc Announces $4 Million Registered Direct Offering","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Poland and U.K. Regulatory Authorities \u2013 URPL and MHRA \u2013 Approve Use of New, Higher-Yielding Manu","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Akebia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akebia Therapeutics Provides Update on Regulatory Process for Vadadustat","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Akebia Therapeutics"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Announces a Case Study from the Phase 3 Part A Clinical Trial of Nomacopan in Pediatric HSCT-TMA Will Be Presented at The European Society for Blood and Marrow Transplantation (EBMT) 49th Annual Meeting","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Akebia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akebia Therapeutics Announces Positive Top-Line Results from Vadadustat Alternative Dosing Study","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Akebia Therapeutics"},{"orgOrder":0,"company":"Vertex Pharmaceuticals","sponsor":"CRISPR Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vertex and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications (BLAs) to the US FDA for Exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Vertex Pharmaceuticals"},{"orgOrder":0,"company":"Bluebird Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bluebird Bio Submits Biologics License Application (BLA) to FDA for Lovotibeglogene Autotemcel (lovo-Cel) for Patients with Sickle Cell Disease (SCD) 12 Years and Older with A History of Vaso-Occlusive Events","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Bluebird Bio"},{"orgOrder":0,"company":"SFJ Pharmaceuticals","sponsor":"Serb","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"SERB 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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Biologics License Applications for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Vertex Pharmaceuticals"},{"orgOrder":0,"company":"Bluebird Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bluebird Bio Announces FDA Priority Review of the Biologics License Application for Lovotibeglogene Autotemcel (Lovo-Cel) for Patients with Sickle Cell Disease (SCD) 12 Years and Older with a History of Vaso-Occlusive Events","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Bluebird Bio"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Receives Positive Opinion on Orphan Drug Designation from the European Medicines Agency for Nomacopan for Treatment in Hematopoietic Stem Cell Transplantation","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"Akari Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Akari Therapeutics Provides Updates on Development of Nomacopan in Pediatric and Adult HSCT-TMA","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Akari Therapeutics"},{"orgOrder":0,"company":"AcelRx Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$26.3 million","upfrontCash":"Undisclosed","newsHeadline":"AcelRx Pharmaceuticals Announces Closing of Previously Announced Private Placement Priced At-The-Market Under Nasdaq Rules","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AcelRx Pharmaceuticals"},{"orgOrder":0,"company":"Bluebird Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"bluebird bio Confirms that FDA has Communicated that Advisory Committee Meeting will not be Scheduled for lovo-cel Gene Therapy for Sickle Cell Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Bluebird Bio"}]

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            Lovo-cel (lovotibeglogene autotemcel) is a one-time gene therapy being investigated for sickle cell disease (SCD), that is designed to add functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic stem cells.

            Lead Product(s): Lovotibeglogene Autotemcel

            Therapeutic Area: Hematology Product Name: Lovo-cel

            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 August 16, 2023

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            The net proceeds will be used to advance Niyad (nafamostat), an investigational broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, mucus clearing and potential anti-viral activities, towards an FDA approval.

            Lead Product(s): Nafamostat

            Therapeutic Area: Hematology Product Name: Niyad

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $26.3 million Upfront Cash: Undisclosed

            Deal Type: Private Placement July 21, 2023

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            rVA576 (nomacopan) is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy.

            Lead Product(s): Nomacopan

            Therapeutic Area: Hematology Product Name: rVA576

            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 13, 2023

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            rVA576 (nomacopan) is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy.

            Lead Product(s): Nomacopan

            Therapeutic Area: Hematology Product Name: rVA576

            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 06, 2023

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            Lovo-cel (lovotibeglogene autotemcel) is a one-time gene therapy being investigated for sickle cell disease (SCD), that is designed to add functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic stem cells.

            Lead Product(s): Lovotibeglogene Autotemcel

            Therapeutic Area: Hematology Product Name: Lovo-Cel

            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 June 21, 2023

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            CTX001 (exagamglogene autotemcel) is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients SCD or TDT, in which a patient’s own hematopoietic stem cell are edited to produce high level of fetal hemoglobin in RBC.

            Lead Product(s): Exagamglogene Autotemcel

            Therapeutic Area: Hematology Product Name: CTX001

            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 June 08, 2023

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            Evrenzo (roxadustat) is an oral medication, comprised of HIF-PH inhibitors that promote erythropoiesis, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology Product Name: Evrenzo

            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, 2023

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            Through the acquisition, SERB has acquired exclusive US rights to the ticagrelor reversal agent PB2452 (bentracimab), a novel, monoclonal antibody fragment, from SFJ. SFJ will remain responsible for the ongoing trials of bentracimab and will work with SERB to submit the BLA.

            Lead Product(s): Bentracimab

            Therapeutic Area: Hematology Product Name: PB2452

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Serb

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition May 11, 2023

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            Details:

            Lovo-cel (lovotibeglogene autotemcel) is a one-time gene therapy being investigated for sickle cell disease (SCD), that is designed to add functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic stem cells.

            Lead Product(s): Lovotibeglogene Autotemcel

            Therapeutic Area: Hematology Product Name: Lovo-cel

            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 April 24, 2023

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            Details:

            rVA576 (nomacopan) is an investigational bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4) currently in Phase 3 clinical trials for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy.

            Lead Product(s): Nomacopan

            Therapeutic Area: Hematology Product Name: rVA576

            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 April 03, 2023

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