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[{"orgOrder":0,"company":"Celcuity","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (Palbociclib) for Planned Phase 3 Clinical Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity to Present Additional Data for Gedatolisib at the 2022 San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+\/HER2- Advanced Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at the 2022 San Antonio Breast Cancer Symposium","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Celcuity","sponsor":"Bayer AG","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa\u00ae (darolutamide) for Planned Phase 1b\/2 Clinical Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces Plan to Conduct Phase 1b\/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2023","url1":"","url2":"","graph1":"Oncology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celcuity Announces First Patient Dosed in Phase 1b\/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]

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            PKI-587 (gedatolisib) is an investigational, intravenously administered pan-class I isoform PI3K and mTOR inhibitor. It is being evaluated in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer.

            Lead Product(s): Gedatolisib,Darolutamide

            Therapeutic Area: Oncology Product Name: PKI-587

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2024

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            Under the agreement, Bayer will provide Nubeqa to Celcuity for its Phase 1b/2 trial of PKI-587 (gedatolisib), a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, in combination with darolutamide in metastatic castration resistant prostate cancer.

            Lead Product(s): Gedatolisib,Darolutamide

            Therapeutic Area: Oncology Product Name: PF-05212384

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bayer AG

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration August 22, 2023

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            PKI-587 (gedatolisib) is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR, and investigating in ombination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer.

            Lead Product(s): Gedatolisib,Darolutamide

            Therapeutic Area: Oncology Product Name: PF-05212384

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 22, 2023

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            PKI-587 (Gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR. Its in Phase 1b clinical trial in combination with palbociclib and endocrine therapy for patients with HR+/HER2- advanced breast cancer.

            Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

            Therapeutic Area: Oncology Product Name: PKI-587

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 09, 2022

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            Gedatolisib for the treatment of HR+/HER2- advanced breast cancer that has progressed after treatment with a CDK4/6 inhibitor in combination with an aromatase inhibitor.

            Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

            Therapeutic Area: Oncology Product Name: PKI-587

            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 December 07, 2022

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            PKI-587 (gedatolisib) is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTOR. Its MOA and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR.

            Lead Product(s): Gedatolisib,Palbociclib,Undisclosed

            Therapeutic Area: Oncology Product Name: PKI-587

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 22, 2022

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            Under the terms of collaboration with Pfizer will provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial to evaluate gedatolisib, in combination with palbociclib, and Faslodex® (fulvestrant), in patients with ER+/HER2- advanced breast cancer.

            Lead Product(s): Gedatolisib,Palbociclib

            Therapeutic Area: Oncology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration November 15, 2021

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