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    Celcuity
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    16305 – 36th Avenue North Suite 100 Minneapolis, MN 55446
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    Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prost...

    Details:

    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 IIProduct 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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    Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical T...

    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 resistant prostate cancer.


    Lead Product(s): Gedatolisib,Darolutamide

    Therapeutic Area: Oncology Product Name: PF-05212384

    Highest Development Status: IND EnablingProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Bayer AG

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration August 22, 2023

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

    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.


    Lead Product(s): Gedatolisib,Darolutamide

    Therapeutic Area: Oncology Product Name: PF-05212384

    Highest Development Status: IND EnablingProduct 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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    Celcuity Presents Updated Results of Phase 1b Study of Gedatolisib in Patients with Advanced Breast Cancer at the 2022 San Antonio Breast Cancer Symposi...

    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 cancer.


    Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

    Therapeutic Area: Oncology Product Name: PKI-587

    Highest Development Status: Phase IProduct 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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    Celcuity Announces First Patient Dosed in Phase 3 VIKTORIA-1 Clinical Trial of Gedatolisib for the Treatment of HR+/HER2- Advanced Breast Cancer

    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.


    Lead Product(s): Gedatolisib,Palbociclib,Fulvestrant

    Therapeutic Area: Oncology Product Name: PKI-587

    Highest Development Status: Phase IIIProduct 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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    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 target PI3K or mTOR.


    Lead Product(s): Gedatolisib,Palbociclib,Undisclosed

    Therapeutic Area: Oncology Product Name: PKI-587

    Highest Development Status: Phase IProduct 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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    Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (Palbociclib) for Planned Phase 3 Clinical Trial

    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 breast cancer.


    Lead Product(s): Gedatolisib,Palbociclib

    Therapeutic Area: Oncology Product Name: Undisclosed

    Highest Development Status: IND EnablingProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Pfizer Inc

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration November 15, 2021

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