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pdufa.bio

Gedatolisib

Updated ยทnext FDA decision on the calendar

Gedatolisib is a Celcuity Inc. program. The FDA approved it on Jul 14, 2026. 1 FDA decision on record below. Every date links its source.

CELC catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Gedatolisib is marketed as REVTORPYK (gedatolisib); the events below include those tracked under the brand name. Sponsor: Celcuity Inc. (CELC). We track 2 catalyst events for this program: 0 upcoming and 2 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

Readout · Jun 2026CELCPDUFA · Jul 14, 2026 ✓ ApprovedCELC

Questions

When is Gedatolisib's next FDA decision or readout?

No upcoming catalyst is on our calendar for Gedatolisib; 1 FDA decision is on record below.

What happened at Gedatolisib's most recent FDA decision?

On Jul 14, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Gedatolisib?

Celcuity Inc. (CELC).

Has Gedatolisib been approved by the FDA?

Yes. The FDA approved an application for Gedatolisib on Jul 14, 2026; the decision page linked above carries the source.

Where does this data come from?

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