Gedatolisib

Phase 3

Celcuity Inc. (CELC) (CELC)

00%

What is LOA?

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

8mo

CELCPDUFA$4.0B

Phase 3

FDA PDUFA Date gedatolisib

Gedatolisib• PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer after endocrine therapy

Jun 25Confirmed

Source

00%

Competitive Landscape

0 competitors in mCRPC (Metastatic Castration-resistant Prostate Cancer)

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Drug Information

Target Indication

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Clinical Trial

NCT06190899

Last updated: 3/26/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Drug Science

Mechanism of action & safety profile

Developer

CELC

Celcuity Inc. (CELC)

Services-Medical Laboratories•North America•NASDAQ

Related Pipeline

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Breast Cancer

TalazoparibPhase 2

TNBC - Triple-Negative Breast Cancer

LY3023414Phase 2

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