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    [{"orgOrder":0,"company":"Pfizer Inc","sponsor":"Celcuity","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Licensing Agreement","leadProduct":"Gedatolisib","moa":"PI3K\/mTOR","graph1":"Oncology","graph2":"Phase I","graph3":"Pfizer Inc","amount2":0.34000000000000002,"highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Oncology","amount2New":0.34000000000000002,"dosageForm":"Intravenous Injection","sponsorNew":"Pfizer Inc \/ Celcuity","highestDevelopmentStatusID":"6","companyTruncated":"Pfizer Inc \/ Celcuity"},{"orgOrder":0,"company":"Celcuity","sponsor":"Pfizer Inc","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Collaboration","leadProduct":"Gedatolisib","moa":"Pan-PI3K class I","graph1":"Oncology","graph2":"IND 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Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Bayer AG","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2023","type":"Collaboration","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Bayer AG","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Bayer AG"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2023","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2024","type":"Not Applicable","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"Infusion","sponsorNew":"Celcuity \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Celcuity \/ Not Applicable"},{"orgOrder":0,"company":"Celcuity","sponsor":"Undisclosed","pharmaFlowCategory":"D","therapeuticArea":"Oncology","country":"U.S.A","productType":"Small molecule","year":"2024","type":"Financing","leadProduct":"Gedatolisib","moa":"","graph1":"Oncology","graph2":"Phase III","graph3":"Celcuity","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Oncology","amount2New":0,"dosageForm":"","sponsorNew":"Celcuity \/ Undisclosed","highestDevelopmentStatusID":"10","companyTruncated":"Celcuity \/ Undisclosed"}]

    Find Clinical Drug Pipeline Developments & Deals for Gedatolisib

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                            01

                            Celcuity

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                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Undisclosed

                            Deal Type : Financing

                            DEALS_DEV arrow-down

                            Celcuity Plans Phase 3 Trial for Gedatolisib in Advanced Breast Cancer with Financing

                            Details : The financing aims to support the clinical development of PKI-587 (gedatolisib), which is being evaluated in the late-stage trial studies for the treatment of HR+/HER2- advanced Breast Cancer.

                            Brand Name : PKI-587

                            Molecule Type : Small molecule

                            Upfront Cash : Undisclosed

                            May 30, 2024

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : Undisclosed

                            Deal Size : Undisclosed

                            Deal Type : Financing

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                            02

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : Phase I/ Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Doses First Patient in Phase 1b/2 Trial of Gedatolisib for Prostate Cancer

                            Details : PKI-587 (gedatolisib) is an intravenously administered pan-class I isoform PI3K and mTOR inhibitor, evaluated with Nubeqa (darolutamide) for metastatic castration-resistant prostate cancer.

                            Brand Name : PKI-587

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            February 22, 2024

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase I/ Phase II

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            03

                            Celcuity

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                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Bayer AG

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darol...

                            Details : 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 res...

                            Brand Name : PF-05212384

                            Molecule Type : Small molecule

                            Upfront Cash : Undisclosed

                            August 22, 2023

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Bayer AG

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

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                            04

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cance...

                            Details : 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.

                            Brand Name : PF-05212384

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            August 22, 2023

                            Lead Product(s) : Gedatolisib,Darolutamide

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            05

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at ...

                            Details : 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 can...

                            Brand Name : PKI-587

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            December 09, 2022

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            06

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Study Phase : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment o...

                            Details : 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.

                            Brand Name : PKI-587

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            December 07, 2022

                            Lead Product(s) : Gedatolisib,Palbociclib,Fulvestrant

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase III

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            07

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Palbociclib,Undisclosed

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

                            DEALS_DEV arrow-down

                            Celcuity to Present Additional Data for Gedatolisib at the 2022 San Antonio Breast Cancer Symposium

                            Details : 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 ta...

                            Brand Name : PKI-587

                            Molecule Type : Small molecule

                            Upfront Cash : Not Applicable

                            November 22, 2022

                            Lead Product(s) : Gedatolisib,Palbociclib,Undisclosed

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase I

                            Sponsor : Not Applicable

                            Deal Size : Not Applicable

                            Deal Type : Not Applicable

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                            08

                            Celcuity

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                            Celcuity

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                            Lead Product(s) : Gedatolisib,Palbociclib

                            Therapeutic Area : Oncology

                            Study Phase : IND Enabling

                            Sponsor : Pfizer Inc

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

                            DEALS_DEV arrow-down

                            Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (Palboc...

                            Details : 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 bre...

                            Brand Name : Undisclosed

                            Molecule Type : Small molecule

                            Upfront Cash : Undisclosed

                            November 15, 2021

                            Lead Product(s) : Gedatolisib,Palbociclib

                            Therapeutic Area : Oncology

                            Highest Development Status : IND Enabling

                            Sponsor : Pfizer Inc

                            Deal Size : Undisclosed

                            Deal Type : Collaboration

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                            09

                            Pfizer Inc

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                            Pfizer Inc

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                            Lead Product(s) : Gedatolisib

                            Therapeutic Area : Oncology

                            Study Phase : Phase I

                            Sponsor : Celcuity

                            Deal Size : $340.0 million

                            Deal Type : Licensing Agreement

                            DEALS_DEV arrow-down

                            Celcuity Announces Licensing Agreement with Pfizer to Develop and Commercialize Gedatolisib

                            Details : Gedatolisib is a Phase 1b pan-PI3K/mTOR inhibitor. Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib.

                            Brand Name : PF-05212384

                            Molecule Type : Small molecule

                            Upfront Cash : $5.0 million

                            April 08, 2021

                            Lead Product(s) : Gedatolisib

                            Therapeutic Area : Oncology

                            Highest Development Status : Phase I

                            Sponsor : Celcuity

                            Deal Size : $340.0 million

                            Deal Type : Licensing Agreement

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