CSBio CSBio

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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 Pharmaceuticals and SFJ Pharmaceuticals Announce a U.S. Partnership for Bentracimab, a Ticagrelor","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"SFJ Pharmaceuticals"},{"orgOrder":0,"company":"FibroGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FibroGen Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"FibroGen"},{"orgOrder":0,"company":"Vertex Pharmaceuticals","sponsor":"Not 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"},{"orgOrder":0,"company":"AcelRx Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AcelRx Receives IDE Approval for Niyad and Advances to a Single Registration Study","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AcelRx Pharmaceuticals"},{"orgOrder":0,"company":"Coherus Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA\u00ae ONBODY\u2122","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Biosimilar","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Coherus Biosciences"},{"orgOrder":0,"company":"Bluebird Bio","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"$103.0 million","upfrontCash":"Undisclosed","newsHeadline":"bluebird bio Enters into Advance Agreement to Sell Priority Review Voucher, if Granted, for $103 Million","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Bluebird Bio"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Johnson & Johnson's Nipocalimab Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Johnson & Johnson Innovative Medicine"}]

Find Hematology Drugs in Phase III Clinical Development in UNITED STATES

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            JNJ-80202135 (nipocalimab) is an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody that selectively blocks FcRn. It is under development for the treatment of severe hemolytic disease of the fetus and newborn (HDFN).

            Lead Product(s): Nipocalimab

            Therapeutic Area: Hematology Product Name: JNJ-80202135

            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 February 09, 2024

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            Under the terms of the agreement, rights to the PRV will transfer to the buyer which is contingent upon the U.S. Food and Drug Administration’s approval of the BLA for lovotibeglogene autotemcel (lovo-cel) and granting of the PRV.

            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: Novartis Pharmaceuticals Corporation

            Deal Size: $103.0 million Upfront Cash: Undisclosed

            Deal Type: Financing October 30, 2023

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            Udenyca Onbody (pegfilgrastim-cbqv) Autoinjector products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Udenyca Onbody

            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 05, 2023

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            Niyad (a lyophilized formulation of 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: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 03, 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 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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