Celcuity Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
11analysts covering
FY Revenue (est.)
$38.7Mnext fiscal year
FY EPS (est.)
-$4.30next fiscal year
Reporting Calendar
| Event | Expected Date |
|---|---|
| Q3 2026 Earnings Release | 16 Nov 2026 |
Monitoring Framework
Key Performance Indicators
PFS (Progression-Free Survival) in VIKTORIA-1 PIK3CA Mutant Cohort QuarterlyTarget: Statistically significant improvement compared to alpelisib plus fulvestrant
Cash Runway (Years of Funding) Quarterly1.5Target: Sufficient to fund operations through 2027
Commercial Launch Readiness Headcount QuarterlyTarget: Scale sales, marketing, and market-access teams ahead of potential approval
Watch Items
- FDA PDUFA Goal Date for Gedatolisib in HR+/HER2-/PIK3CA WT Advanced Breast CancerTrigger: July 17, 2026Action: Monitor FDA decision on approval; prepare for immediate commercial launch if approved.
- Supplemental NDA (sNDA) Submission for PIK3CA Mutant CohortTrigger: Following positive Phase 3 VIKTORIA-1 mutant cohort dataAction: Compile and submit clinical data package to the FDA to expand the gedatolisib label.
- European Marketing Authorization Application (MAA) SubmissionAction: Prepare regulatory filings for European Medicines Agency (EMA) and accelerate regional partnership discussions.
Research as of 19 Jun 2026