Seqens Seqens

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[{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Initiates Phase 2b Clinical Trial of Lead Candidate RZ358","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute, Inc. Announces Updates to Clinical and Business Operations in Response to COVID-19 Pandemic","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute to Present Clinical Data for RZ358, Lead Candidate in Phase 2b Trial in Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Receives Rare Pediatric Disease Designation for RZ358","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Publication of RZ402 Data in Diabetic Macular Edema (DME) in Investigative Ophthalmology & Visual Science","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Resumption and US-Expansion of its Phase 2b Study in Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Cam Capital","pharmaFlowCategory":"D","amount":"$41.0 million","upfrontCash":"Undisclosed","newsHeadline":"Rezolute Announces $41 Million Private Placement with Leading Investment Firms and Prepares to Imminently Up-List to Nasdaq","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"XOMA","pharmaFlowCategory":"D","amount":"$1.9 million","upfrontCash":"Undisclosed","newsHeadline":"XOMA Earns $1.9 Million Associated with Two Partner Developments","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears Rezolute\u2019s IND Application for RZ402","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Presents Data on RZ358 in Post-Gastric Bypass Hypoglycemia at ENDO 2021","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"SLR Capital Partners","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Rezolute Announces $30 Million Debt Financing Agreement with SLR Capital Partners","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Presents Results from Two-Week Natural History Study in Congenital Hyperinsulinism Patients on Standard of Care Therapies at ESPE 2021","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Positive Results from the Phase 2b RIZE Study of RZ358 in Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$130.0 million","upfrontCash":"Undisclosed","newsHeadline":"Rezolute, Inc. Announces Aggregate $130 Million Registered Direct Offering and Concurrent Private Placement Priced Atthe-Market","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Jefferies","pharmaFlowCategory":"D","amount":"$122.0 million","upfrontCash":"Undisclosed","newsHeadline":"Rezolute, Inc. Announces Closing of Registered Direct Offering","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Positive Data from its Phase 2b (RIZE) Study of RZ358 in Patients with Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute to Initiate a Pivotal Phase 3 Study of RZ358 in Participants 3 Months of Age and Older with Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Announces Further Evidence of RZ358's Efficacy in Tumor-Mediated Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Initiates Phase 3 Clinical Study for RZ358 in Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Completes Enrollment of its Phase 2 Study in Diabetic Macular Edema (DME)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Rezolute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Rezolute Reports Validation of the Potential Use of RZ358 for Treatment of Non-Islet Cell Tumor Hypoglycemia (NICTH)","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Preclinical"}]

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            Rezolute candidate RZ358, which is an insulin receptor allosteric site activator. Currently, it is being evaluated in the preclinical trial studies for the treatment of Non-Islet Cell Tumor Hypoglycemia.

            Lead Product(s): Ersodetug

            Therapeutic Area: Rare Diseases and Disorders Product Name: RZ358

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 06, 2024

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            RZ358 is a fully human monoclonal antibody that works downstream from the pancreas and instead binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle. It is under phase 3 trials for Congenital Hyperinsulinism.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            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 January 23, 2024

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            RZ358 is a fully human monoclonal antibody that works downstream from the pancreas and instead binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle. It is under phase 3 clinical development for the treatment of Congenital Hyperinsulinism.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            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 December 14, 2023

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            RZ402 is a selective and potent plasma kallikrein inhibitor (PKI). It is being developed as a potential oral therapy for the chronic treatment of diabetic macular edema DME.

            Lead Product(s): RZ402

            Therapeutic Area: Ophthalmology Product Name: RZ402

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 13, 2023

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            RZ358 is a human monoclonal antibody that binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle being investigated for the treatment of Congenital Hyperinsulinism.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            Highest Development Status: Preclinical Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 11, 2023

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            RZ358 is a human monoclonal antibody that binds to a unique allosteric site on insulin receptors in the liver, fat, and muscle being investigated for the treatment of Congenital Hyperinsulinism.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 27, 2023

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            Details:

            RZ402 is a selective and potent PKI being developed as a potential once-daily oral therapy for the chronic treatment of DME. By inhibiting the formation of kallikrein, RZ402 is designed to block downstream bradykinin production.

            Lead Product(s): RZ402

            Therapeutic Area: Ophthalmology Product Name: RZ402

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2022

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            Details:

            Rezolute intends to use the net proceeds from the offering to fund the continued activities for development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema and other pipeline development, and for working capital and general corporate purposes.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $122.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 04, 2022

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            Details:

            Rezolute intends to use the net proceeds from these offerings to fund the continued activities for development of RZ358 for Congenital Hyperinsulinism and RZ402 for Diabetic Macular Edema and other pipeline development, working capital, and general corporate purposes.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Jefferies

            Deal Size: $130.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 01, 2022

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            Details:

            Results are Phase 3 enabling and demonstrate the potential for RZ358, a human monoclonal antibody to be used as a monotherapy as well as a potential universal therapy for all forms of hyperinsulinism.

            Lead Product(s): RZ358

            Therapeutic Area: Genetic Disease Product Name: RZ358

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 01, 2022

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