Celcuity/$CELC

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About Celcuity

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.
Ticker
$CELC
Sector
Health
Primary listing
NASDAQ
Employees
155

Celcuity Metrics

BasicAdvanced
$4B
-
-$4.32
0.20
-

What the Analysts think about Celcuity

Analyst ratings (Buy, Hold, Sell) for Celcuity stock.
Analyst projections of the future price of Celcuity stock.

Bulls say / Bears say

Positive topline results from the Phase 3 VIKTORIA-1 PIK3CA mutant cohort showed clinically meaningful PFS improvement in HR+/HER2- PIK3CA MT advanced breast cancer post-CDK4/6 therapy, highlighting gedatolisib’s potential as a novel second-line regimen. (Celcuity)
The PIK3CA MT cohort of VIKTORIA-1 doubled the likelihood of PFS compared to alpelisib plus fulvestrant, supported by a planned Q3 2026 sNDA submission and a preferred Category 1 NCCN guideline recommendation, positioning gedatolisib to capture market share. (Celcuity)
The FDA granted Priority Review for Celcuity’s NDA of gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, assigning a PDUFA date of July 17, 2026, accelerating the regulatory timeline for its wild-type indication. (Celcuity)
Celcuity is a clinical-stage biotechnology company with a limited operating history, having incurred significant losses and lacking any approved or commercially marketed products, making future profitability uncertain. (SEC)
The company’s valuation hinges solely on gedatolisib, with critical readouts pending from the Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials; a negative or delayed outcome would leave Celcuity without fallback assets. (Celcuity) (SEC)
Substantial R&D expenditures and reliance on external financing obligate Celcuity to pursue additional capital raises, which could dilute existing shareholders and exert downward pressure on the stock. (SEC)
Data summarised monthly by Lightyear AI. Last updated on 22 Aug 2026.

Celcuity Financial Performance

Revenues and expenses
Income statement
QuarterlyAnnual
Q3 24
QoQ growth
Revenue
Net income
Profit margin

Celcuity Earnings Performance

Company profitability
Earnings per share
QuarterlyAnnual
Q4 23
Q1 24
Q2 24
Q3 24
Q4 24
Actual
Expected
Surprise
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