Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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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 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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. 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molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"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 Statistically Significant Proteinuria Reduction in Patients With C3 Glomerulopathy (C3G)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Update on CRYSTALIZE Evidence Trials","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"orgOrder":0,"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ZORA Real-World Evidence Demonstrates that Lokelma Substantially Increases Cardiorenal Patients\u2019 Chances of Maintaining Lifesaving RAASi Therapy","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"orgOrder":0,"company":"Otsuka Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Large molecule","graph2":"Otsuka Pharmaceutical"},{"orgOrder":0,"company":"Vertex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2\/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Vertex Pharmaceuticals"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Novartis Fabhalta\u00ae (iptacopan) Data Show Clinically Meaningful and Statistically Significant Proteinuria Reduction of 38.3% Versus Placebo for Patients with IgA nephropathy (IgAN)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"}]

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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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            Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway. It is being evaluated for the treatment of patients with IgA nephropathy (IgAN).

            Lead Product(s): Iptacopan Hydrochloride

            Therapeutic Area: Nephrology Product Name: Fabhalta

            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 April 15, 2024

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            VX-147 (inaxaplin) is an oral, small-molecule inhibitor of APOL1 channel function, which is being evaluated for the treatment of APOL1-mediated kidney disease.

            Lead Product(s): Inaxaplin

            Therapeutic Area: Nephrology Product Name: VX-147

            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 April 01, 2024

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            VIS649 (sibeprenlimab) is an investigational humanized IgG2 monoclonal antibody that reduces the production of Gd-IgA1 by binding to a specific signaling molecule called APRIL. It is being developed for the treatment of Immunoglobulin A Nephropathy.

            Lead Product(s): Sibeprenlimab

            Therapeutic Area: Nephrology Product Name: VIS649

            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 16, 2024

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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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