Upcoming FDA decision · December 17, 2026
Relacorilant PDUFA date: FDA decision expected December 17, 2026
60 days to goCorcept Therapeutics Incorporated (CORT) →
The FDA is expected to decide on Relacorilant from Corcept Therapeutics Incorporated in Cushing's syndrome (hypercortisolism) by the PDUFA target action date of December 17, 2026. For Cushing's syndrome (hypercortisolism). NDA filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
December 17
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Relacorilant?
- The FDA's PDUFA target action date for Relacorilant is December 17, 2026. The FDA can act before that date, and the review can be extended.
- What is Relacorilant being reviewed for?
- The application under FDA review covers Cushing's syndrome (hypercortisolism).
- Which company is developing Relacorilant?
- Corcept Therapeutics Incorporated (CORT).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).