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CELC PDUFA Date: Gedatolisib with Fulvestrant

FDA decision (PDUFA) target 2026-07-17 · Celcuity Inc. · HR+/HER2- advanced breast cancer
More Cancer & Oncology FDA decisions →All July 2026 PDUFA dates →

The story

Gedatolisib with Fulvestrant is under FDA review to treat HR+/HER2- advanced breast cancer. Balance sheet: about 10 months of cash, runway into 2027 (company-guided). ELEVATED — under 12 months
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapVERA . 2026-07-07Same month decision . Atacicept
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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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.