Celcuity Inc., a clinical-stage biotechnology company, focuses on the development of targeted therapies for the treatment of various solid tumors in the United States. The company's lead drug candidate includes Gedatolisib, which selectively targets various Class I isoforms of phosphatidylinositol-3-kinase (PI3K) and the two mechanistic targets of rapamycin (mTOR) sub-complexes, mTORC1 and mTORC2 to treat patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) or HR+/HER2-, advanced or metastatic breast cancer (ABC), and patients with metastatic castration resistant prostate cancer (mCRPC). The company had a license agreement with Pfizer Inc. for the development and commercialization rights to Gedatolisib. Celcuity Inc. was incorporated in 2011 and is based in Minneapolis, Minnesota. Show more

2800 Campus Drive, Minneapolis, MN, 55441, United States

Biotechnology
Healthcare

Market Cap

4.303B

52 Wk Range

$11.28 - $151.02

Previous Close

$88.24

Open

$88.54

Volume

430,415

Day Range

$86.91 - $89.50

Enterprise Value

4.24B

Cash

387.1M

Avg Qtr Burn

-55.07M

Insider Ownership

10.03%

Institutional Own.

-

Qtr Updated

03/31/26


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Drug & IndicationStage & EventCatalyst Date
Gedatolisib + palbociclib + fulvestrant (gedatolisib triplet) Details
HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer (ABC)

PDUFA

Approval decision

Gedatolisib (PKI-587) (PI3K/mTOR Inhibitor) Details
HR+/HER2-/PIK3CA Mutated Advanced Breast Cancer (ABC)

sNDA

Submission

Gedatolisib + trastuzumab-pkrb Details
HER2+ Metastatic Breast Cancer (mBC)

Phase 3

Update

Gedatolisib (Gedatolisib) (PAM Pathway Inhibitor) Details
HR+/HER2-/PIK3CA Mutant Advanced Breast Cancer (ABC)

Phase 3

Update

Gedatolisib + darolutamide (Nubeqa®) Details
Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1

Update