Seqens Seqens

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[{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Announces a Phase 2 Study Result of tenapanor (KHK7791) for Hemodialysis Patients with Hyperphosphatemia in Japan","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Acceptance for Filing of its NDA of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Data Supporting Efficacy and Safety of Tenapanor to be Presented at ASN's Kidney Week 2020","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx and Kyowa Kirin Highlight New Data Supporting the Clinical Safety and Efficacy of Tenapanor at ASN's Kidney Week 2020","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Provides Corporate Update Following Type A Meeting with FDA","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Launching IBSRELA Second Quarter of 2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces US Launch of IBSRELA\u00ae, a New First-in-Class Treatment for IBS-C in Adults","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Plan to Convene Advisory Committee for XPHOZAH\u00ae (tenapanor)","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces Additional Data Supporting the Efficacy and Safety of First-In-Class IBSRELA\u00ae (tenapanor) for Adults with IBS-C, to be Presented at DDW 2022","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Presents Data at DDW 2022 on IBSRELA\u00ae (tenapanor), a First-In-Class Treatment for IBS-C in Adults","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"HealthCare Royalty Partners","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"$10.0 million","newsHeadline":"Ardelyx Announces $20 Million Financing Agreement with HealthCare Royalty Partners","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Announces FDA Advisory Committee Meeting to Review XPHOZAH\u00ae NDA Tentatively Scheduled for November 16, 2022","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Kyowa Kirin","pharmaFlowCategory":"D","amount":"$520.5 million","upfrontCash":"$10.5 million","newsHeadline":"Ardelyx Collaboration Partner, Kyowa Kirin, Announces Submission of New Drug Application for Tenapanor for Hyperphosphatemia in Japan","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH\u00ae (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dial","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ardelyx Provides Update on FDA Appeal for XPHOZAH\u00ae (tenapanor) for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase IV"},{"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":"Nephrology","graph2":"Phase III"},{"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":"Nephrology","graph2":"Phase III"},{"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":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tenapanor for Hyperphosphatemia Approved in Japan","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"SLR Capital Partners","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Ardelyx Announces Amendment of Debt Financing Agreement with SLR Capital Partners to Provide $50 Million of Additional Committed Capital","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"Ardelyx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves XPHOZAH\u00ae (tenapanor), a First-in-Class Phosphate Absorption Inhibitor","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"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":"Nephrology","graph2":"Phase III"}]

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            Details:

            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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            The financing will support the commercialization of company's two FDA approved products, Ibsrela (tenapanor), for irritable bowel syndrome with constipation, and Xphozah (tenapanor), indicated to reduce serum phosphorus in adults with chronic kidney disease.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: SLR Capital Partners

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing October 17, 2023

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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 in adult with chronic kidney disease on dialysis.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 17, 2023

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            Phozevel (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 NHE3, indicated for the treatment improvement of hyperphosphatemia in adult patients with CKD on dialysis.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Phozevel

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 25, 2023

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            The agreement provides Fosun Pharma the rights to develop and commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with irritable bowel syndrome with constipation and for the treatment of hyperphosphatemia related to chronic kidney disease.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Fosun Pharmaceutical

            Deal Size: $125.0 million Upfront Cash: $12.0 million

            Deal Type: Licensing Agreement July 13, 2023

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            Details:

            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 in adult with chronic kidney disease on dialysis.

            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 May 17, 2023

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            Details:

            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 in adult with chronic kidney disease on dialysis.

            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 April 18, 2023

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            Details:

            Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            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 December 16, 2022

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            Details:

            XPHOZAH (tenapanor),is an investigational first-in-class phosphate absorption inhibitor, With its unique blocking MOA, XPHOZAH acts locally in gut, reducing phosphate absorption through paracellular pathway, primary pathway of phosphate absorption.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 03, 2022

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            Details:

            Under the terms of the agreement, Ardelyx will execute a research plan to advance two of Ardelyx’s ongoing research programs focused on the identification and design of Tenapanor (xphozah), a phosphate absorption inhibitor, for the treatment of Hyperphosphatemia.

            Lead Product(s): Tenapanor

            Therapeutic Area: Nephrology Product Name: Xphozah

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Kyowa Kirin

            Deal Size: $520.5 million Upfront Cash: $10.5 million

            Deal Type: Licensing Agreement October 31, 2022

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