CELC

gedatolisib

FDA PDUFA Target Action Date · Celcuity Inc.

Friday, July 17, 2026

Approved

approved

Note: Approved 2026-07-14 as REVTORPYK (ORIG NDA219908). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 3d from the PDUFA date.

Drug Information

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

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

Explore Celcuity Inc.

View Celcuity Inc.'s full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

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