CELC

Celcuity Inc.

FDA PDUFA Target Action Date

Friday, July 17, 2026

52 days away

Drug Information

Drug Name: gedatolisib (CT.gov)
Application Type: NDA
Indication: HR+/HER2-/PIK3CA wild-type ( WT ) advanced breast cancer ( ABC )

Filing Details

Company: Celcuity Inc.
Stock Ticker: CELC
SEC CIK: 0001603454
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue