---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-338184"
form_type: "8-K"
ticker: "CORT"
cik: "0001088856"
company_name: "CORCEPT THERAPEUTICS INC"
filed_at: "2025-12-31T23:59:59+00:00"
generated_at: "2026-05-16T11:52:45.639244+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.78
calibrated_materiality_score: 0.78
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Corcept's relacorilant NDA in hypercortisolism

## Summary
- FDA concluded benefit-risk assessment unfavorable without additional effectiveness evidence.
- Pivotal GRACE trial met primary endpoint; GRADIENT trial provided confirmatory evidence.
- CEO Joseph Belanoff expressed surprise and disappointment; plans to meet with FDA.
- Relacorilant was under review for hypertension secondary to hypercortisolism.

## SEC filing metadata
- accession: 0001193125-25-338184
- form_type: 8-K
- ticker: CORT
- cik: 0001088856
- company_name: CORCEPT THERAPEUTICS INC
- filed_at: 2025-12-31T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.78
- calibrated_materiality_score: 0.78
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/0001193125-25-338184-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/d50993d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-338184
- JSON: https://secwatch.observer/filing/0001193125-25-338184.json
- Plain text: https://secwatch.observer/filing/0001193125-25-338184.txt

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