Celcuity/$CELC

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About Celcuity

Celcuity Inc is a clinical-stage biotechnology company pursuing development for oncology. The Company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients.

Ticker

$CELC
Sector
Primary listing

Employees

87

Celcuity Metrics

BasicAdvanced
$2.2B
-
-$3.45
0.68
-

What the Analysts think about Celcuity

Analyst ratings (Buy, Hold, Sell) for Celcuity stock.

Bulls say / Bears say

Topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial showed the gedatolisib combination cut the risk of disease progression or death by 76% (HR 0.24), achieving a median progression-free survival of 9.3 months compared to 2.0 months for fulvestrant, representing unprecedented efficacy in HR+/HER2– advanced breast cancer.
The FDA has agreed to review the gedatolisib NDA through its Real-Time Oncology Review (RTOR) program, potentially speeding up the review process and supporting an earlier approval decision.
A financing round completed in Q2 2025 secured net proceeds of $286.5 million, giving the company a pro forma cash balance of $455 million—enough, management says, to fund operations through 2027 and support regulatory and commercial efforts.
AstraZeneca and Daiichi Sankyo’s Datroway antibody–drug conjugate has delivered significant improvements in overall survival and progression-free survival in late-stage breast cancer, potentially reducing the market potential for gedatolisib.
BioNTech and Duality Biologics’ precision therapy BNT323 showed strong progression-free survival outcomes in HER2-positive advanced breast cancer, highlighting increased competition that could limit gedatolisib’s adoption if it does not secure additional indications.
The PIK3CA-mutant arm of the Phase 3 VIKTORIA-1 trial is still enrolling, with topline results not expected until Q4 2025, creating ongoing execution risk and delaying potential commercial validation.
Data summarised monthly by Lightyear AI. Last updated on 8 Oct 2025.

Celcuity Financial Performance

Revenues and expenses
QuarterlyAnnual
Q3 24
QoQ growth
Revenue
$37B
-39.75%
Net income
$45B
107.52%
Profit margin
37.65%
6.78%

Celcuity Earnings Performance

Company profitability
QuarterlyAnnual
Q4 23
Q1 24
Q2 24
Q3 24
Q4 24
Actual
$3.69
$2.85
$2.45
$2.42
-
Expected
$3.55
$2.61
$2.05
$2.31
$3.94
Surprise
3.94%
9.20%
19.51%
4.63%
-
Data displayed above is indicative only and its accuracy or completeness is not guaranteed. Actual execution price may vary. Past performance is not indicative of future results. Your return may be affected by currency fluctuations and applicable fees and charges. Capital at risk.
Real-time US market data is sourced from the IEX order book provided by Polygon. After-hours US market data is 15 minutes delayed and may differ significantly from the actual tradable price at market open.

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