---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-044123"
form_type: "8-K"
ticker: "CORT"
cik: "0001088856"
company_name: "CORCEPT THERAPEUTICS INC"
filed_at: "2025-03-03T23:59:59+00:00"
generated_at: "2026-05-25T16:51:16.379517+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Corcept's NDA for relacorilant in Cushing's syndrome; PDUFA Dec 30, 2025

## Summary
- FDA filed relacorilant NDA for endogenous hypercortisolism (Cushing's syndrome).
- PDUFA target action date set for December 30, 2025.
- NDA supported by positive GRACE, GRADIENT, and Phase 2 trial results.
- No drug-induced adrenal insufficiency, hypokalemia, or QT prolongation observed in trials.
- CEO states relacorilant has potential to become new standard of care.

## SEC filing metadata
- accession: 0001193125-25-044123
- form_type: 8-K
- ticker: CORT
- cik: 0001088856
- company_name: CORCEPT THERAPEUTICS INC
- filed_at: 2025-03-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1088856/000119312525044123/0001193125-25-044123-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1088856/000119312525044123/d914293d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-044123
- JSON: https://secwatch.observer/filing/0001193125-25-044123.json
- Plain text: https://secwatch.observer/filing/0001193125-25-044123.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.