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Celcuity Inc

CELC
Healthcare|Biotechnology|USA
$107.58
-5.93 (-5.22%)
Tangible Book
$1.11
Earnings Power
$1.12

About

Celcuity Inc is a clinical-stage biotechnology company developing targeted therapies for multiple solid tumors. Its candidate, gedatolisib, is a kinase inhibitor of the PI3K/AKT/mTOR (PAM) pathway, binding all class I PI3K isoforms and mTORC1/2, offering comprehensive inhibition with a mechanism and pharmacokinetics differentiated from other therapies. The Phase 3 VIKTORIA-1 trial, evaluating gedatolisib with fulvestrant, with or without palbociclib, in HR+/HER2- breast cancer, has completed enrollment and reported results for PIK3CA WT tumors, with cohort 2 (PIK3CA MT) also enrolled. Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials, evaluating combinations in endocrine-resistant HR+/HER2- breast cancer and metastatic castration-resistant prostate cancer, are ongoing.

Stock Price

+689.9%(1Y)

Pipeline Summary

11 total trials
4
Phase 1
7
Phase 2
2
Phase 3
0
Phase 4
Recruiting: 3AVAILABLE: 1Active: 2Unknown: 2Completed: 1Terminated: 1Withdrawn: 1

Active Trials (5)

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06190899mCRPC (Metastatic Castration-resistant Prostate Cancer)
Phase 1Phase 2Recruiting
Enrollment: 54 participants
Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers
NCT03911973TNBC - Triple-Negative Breast Cancer
Phase 1Phase 2Active
Enrollment: 37 participants
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
NCT05501886Breast Cancer
Phase 3Active
Enrollment: 701 participants
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
NCT06757634Breast Cancer
Phase 3Recruiting
Enrollment: 1,180 participants
RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer
NCT03675893Endometrial Cancer
Phase 2Recruiting
Enrollment: 110 participants

BioScore

5.3/10
Watchlist

Ownership

Recent Insider Trades

Dalvey DavidSELL
2026-05-0425,000 shares @ $140.68
Buller Richard ESELL
2026-05-049,000 shares @ $140.46
Buller Richard ESELL
2026-03-313,000 shares @ $110.27
Dalvey DavidSELL
2026-01-2720,000 shares @ $120.03
Buller Richard ESELL
2025-12-053,000 shares @ $105.69
Data last updated: Jul 13, 2026, 12:40 PM