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pdufa.bio

Gedatolisib with

Updated ยทnext FDA decision on the calendar

Gedatolisib with is a Celcuity Inc. program in HR+/HER2- advanced breast cancer. Every date links its source.

CELC catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: HR+/HER2- advanced breast cancer. Sponsor: Celcuity Inc. (CELC). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Jul 17, 2026CELC

Questions

When is Gedatolisib with's next FDA decision or readout?

No upcoming catalyst is on our calendar for Gedatolisib with; no FDA decisions are on record below.

What happened at Gedatolisib with's most recent FDA decision?

No FDA decision for Gedatolisib with is in our archive yet.

What is Gedatolisib with used for?

In our records Gedatolisib with is under review or in development for HR+/HER2- advanced breast cancer.

Who makes Gedatolisib with?

Celcuity Inc. (CELC).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.