pdufa.bio

Relacorilant

Page updated ·next FDA decision on the calendar ·Data as of Oct 13, 2026 11:39 PM ET

Relacorilant is a Corcept Therapeutics Inc program in cushing's syndrome (hypercortisolism). Its next catalyst is a Readout in Dec 2026. 2 FDA decisions on record below. Every date links its source.

CORT catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

FDA approval tracked on pdufa.bio: platinum-resistant ovarian cancer (approved Mar 25, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Indication under review: Cushing's syndrome (hypercortisolism). Sponsor: Corcept Therapeutics Inc (CORT). Review status: Corcept resubmitted the NDA for relacorilant in Cushing's syndrome in June 2026, after a December 2025 CRL, and states a PDUFA date of December 17, 2026 in its second-quarter release. Market-cap tier at the time we tracked it: Large. We track 4 catalyst events for this program: 2 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

FDA decision · Dec 31, 2025 CRLCORTFDA decision · Mar 25, 2026 ✓ ApprovedCORTReadout · Dec 2026CORTPDUFA · Dec 17, 2026CORT

Specialist biotech funds holding CORT, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Perceptive Advisors398,385$34.6 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is Relacorilant's next FDA decision or readout?

The next tracked catalyst for Relacorilant is a Readout in Dec 2026.

What happened at Relacorilant's most recent FDA decision?

On Mar 25, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Relacorilant used for?

In our records Relacorilant is FDA-approved for platinum-resistant ovarian cancer (approved Mar 25, 2026), and under review or in development for Cushing's syndrome (hypercortisolism). Other approved uses may not be tracked here; the FDA label is the full record.

Who makes Relacorilant?

Corcept Therapeutics Inc (CORT).

Has Relacorilant been approved by the FDA?

Yes. The FDA approved an application for Relacorilant on Mar 25, 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.