pdufa.bio
CalendarDecisionsApprovals/yrTrial oddsLearnResearchMethodology
Home › PDUFA Calendar › CELC

CELC PDUFA Date: Gedatolisib with Fulvestrant

FDA decision (PDUFA) target 2026-07-17 · Celcuity Inc. · HR+/HER2- advanced breast cancer

CELC run-up into the PDUFA (last ~120 days)

$144.98$87.32
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-07-17
Drug / candidateGedatolisib with Fulvestrant
IndicationHR+/HER2- advanced breast cancer
CompanyCelcuity Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT05501886 · active

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

Track this live → price, options (expected move & IV) and the full dashboard
Opens the pdufa.bio app (private beta)

FAQ

When is the CELC PDUFA date?
The FDA PDUFA target date for CELC (Celcuity Inc.) is 2026-07-17 for Gedatolisib with Fulvestrant. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is CELC's drug Gedatolisib with Fulvestrant?
Gedatolisib with Fulvestrant is Celcuity Inc.'s candidate under FDA review for HR+/HER2- advanced breast cancer.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.