CSBio CSBio

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therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Humacyte"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for XPHOZAH\u00ae (tenapanor)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ardelyx"},{"orgOrder":0,"company":"Travere Therapeutics","sponsor":"CSL Vifor","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Travere Therapeutics Announces Topline Results from Two-Year Primary Efficacy Endpoint in Pivotal Phase 3 DUPLEX Study of Sparsentan in Focal Segmental Glomerulosclerosis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Travere Therapeutics"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Reata Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Announces Phase III Study Results of bardoxolone methyl (RTA 402) in Japan and Discontinuation of Development","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Kyowa Kirin"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Acceptance and Six-Month Review for Resubmission of its New Drug Application of XPHOZAH (tenapanor)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ardelyx"},{"orgOrder":0,"company":"Lupus Therapeutics","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lupus Therapeutics Partners to Evaluate Potential Treatment for SLE and Lupus Nephritis Through North American Trial Network","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Lupus Therapeutics"},{"orgOrder":0,"company":"Vera Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vera Therapeutics Initiates Pivotal Phase 3 (ORIGIN 3) Clinical Trial of Atacicept for the Treatment of IgA Nephropathy (IgAN)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Vera Therapeutics"},{"orgOrder":0,"company":"Chinook Therapeutics","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"$3,500.0 million","upfrontCash":"$3,500.0 million","newsHeadline":"Novartis Bolsters Innovative Medicines Strategy and Renal Pipeline with Agreement to Acquire Chinook Therapeutics for USD 3.2bn Upfront (USD 40 \/ share)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Chinook Therapeutics"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer to Start Phase III Study with Finerenone in Adults with Chronic Kidney Disease and Type 1 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer to Start Phase III Study with Finerenone in Adults with Chronic Kidney Disease and Type 1 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Fosun Pharmaceutical","pharmaFlowCategory":"D","amount":"$125.0 million","upfrontCash":"$12.0 million","newsHeadline":"Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ardelyx"},{"orgOrder":0,"company":"Chinook Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chinook Therapeutics Announces First Patient Enrolled in Pivotal Phase 3 BEYOND Study of Zigakibart (BION-1301) for Patients with IgA Nephropathy","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Chinook Therapeutics"},{"orgOrder":0,"company":"Chinook Therapeutics","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"$3,500.0 million","upfrontCash":"$3,500.0 million","newsHeadline":"Novartis Completes Acquisition of Chinook Therapeutics","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Chinook Therapeutics"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Investigational Iptacopan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"KBP Biosciences","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","amount":"$1,300.0 million","upfrontCash":"Undisclosed","newsHeadline":"Novo Nordisk to Acquire Ocedurenone for Uncontrolled Hypertension from KBP Biosciences","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"KBP Biosciences"},{"orgOrder":0,"company":"Omeros","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Omeros Corporation Provides Update on Interim Analysis of ARTEMIS-IGAN Phase 3 Trial of Narsoplimab in IgA Nephropathy","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Omeros"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"XPHOZAH\u00ae (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Ardelyx"},{"orgOrder":0,"company":"ProKidney","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT\u00ae) for Diabetic CKD and Provides Corporate Updates","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"ProKidney"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Investigational Atrasentan Phase III Study Demonstrates Clinically Meaningful and Highly Statistically Significant Proteinuria Reduction in Patients with IgA Nephropathy (IgAN)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"SanReno Therapeutics","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"SanReno Therapeutics Announces Acquisition by Novartis in Pivotal Transaction to Bring Forward Transformative Therapeutics in Kidney Disease","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"SanReno Therapeutics"},{"orgOrder":0,"company":"Vera Therapeutics","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$287.5 million","upfrontCash":"Undisclosed","newsHeadline":"Vera Therapeutics Announces Closing of Upsized Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares in Public Offering of Class A Common Stock","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Vera Therapeutics"},{"orgOrder":0,"company":"Vera Therapeutics","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$250.0 million","upfrontCash":"Undisclosed","newsHeadline":"Vera Therapeutics Announces Pricing of Upsized Public Offering of Class A Common Stock","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Vera Therapeutics"}]

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            Chinook Therapeutics in-license of atrasentan provides a unique opportunity for Chinook to add a potential new drug to its precision medicine portfolio for the treatment of rare CKD conditions.

            Lead Product(s): Atrasentan

            Therapeutic Area: Nephrology Product Name: CHK-01

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Chinook Therapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement January 10, 2020

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            The net proceeds will be used to fund company's Phase 3 clinical trial of VT-001 (atacicept), a fusion protein self-administered as a subcutaneous injection, in IgAN, regulatory submissions and, to the extent approved, preparation for commercial launch.

            Lead Product(s): Atacicept

            Therapeutic Area: Nephrology Product Name: VT-001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: $287.5 million Upfront Cash: Undisclosed

            Deal Type: Public Offering February 01, 2024

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            The net proceeds will be used to fund the development of the VT-001 (atacicept), which helps to produce autoantibodies contributing to certain autoimmune diseases including IgAN, also known as berger’s disease and lupus nephritis.

            Lead Product(s): Atacicept

            Therapeutic Area: Nephrology Product Name: VT-001

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: $250.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering January 29, 2024

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            Novartis will acquire SanReno's pipeline and capabilities, including the exclusive rights for Greater China and Singapore for two late-stage assets targeting IgAN, ABT-627 (atrasentan), an oral ERA antagonist and zigakibart, a subcutaneously administered monoclonal antibody.

            Lead Product(s): Atrasentan

            Therapeutic Area: Nephrology Product Name: ABT-627

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition January 05, 2024

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            Xphozah (tenapanor) is a first-in-class, phosphate absorption inhibitor that has a novel mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), indicated for the treatment of pediatric Hyperphosphatemia.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            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 15, 2023

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            REACT, a renal autologous homologous cell admixture, is made from expanded autologous SRCs, obtained from each individual subject’s kidney biopsy. REACT is currently in a Phase 3 development program for Diabetic Kidney Disease.

            Lead Product(s): Renal Autologous Cell Therapy

            Therapeutic Area: Nephrology Product Name: REACT

            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 November 13, 2023

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            CHK-01 (atrasentan hydrochloride) is an investigational oral endothelin A receptor antagonist (ERA), currently in Phase III development for IgAN and early-stage development for other rare kidney diseases

            Lead Product(s): Atrasentan

            Therapeutic Area: Nephrology Product Name: CHK-01

            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 30, 2023

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            CHK-01 (atrasentan hydrochloride), an oral endothelin A receptor antagonist is being evaluated phase 3 clinical trials for proteinuria reduction in patients with IgA nephropathy.

            Lead Product(s): Atrasentan

            Therapeutic Area: Nephrology Product Name: CHK-01

            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 30, 2023

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            Through the acquisition, Novo Nordisk gains access to KBP-5074 (ocedurenone), an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist (nsMRA), for uncontrolled hypertension with potential application in cardiovascular and kidney disease.

            Lead Product(s): Ocedurenone

            Therapeutic Area: Nephrology Product Name: KBP-5074

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novo Nordisk

            Deal Size: $1,300.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition October 16, 2023

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            OMS721 (Narsoplimab) is a MASP-2 inhibitor that targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

            Lead Product(s): Narsoplimab

            Therapeutic Area: Nephrology 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 16, 2023

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