---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-199706"
form_type: "8-K"
ticker: "CORT"
cik: "0001088856"
company_name: "CORCEPT THERAPEUTICS INC"
filed_at: "2025-09-10T23:59:59+00:00"
generated_at: "2026-05-17T06:57:22.191815+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Corcept's NDA for relacorilant in platinum-resistant ovarian cancer; PDUFA July 11, 2026

## Summary
- FDA accepted Corcept's NDA for relacorilant in platinum-resistant ovarian cancer with a PDUFA date of July 11, 2026.
- NDA based on positive Phase 3 ROSELLA and Phase 2 data showing improved PFS and OS without biomarker selection.
- Relacorilant plus nab-paclitaxel was well-tolerated; adverse events similar to nab-paclitaxel monotherapy.
- CEO Joseph Belanoff: 'FDA acceptance brings us closer to offering a much-needed treatment option for this dire disease.'
- Relacorilant may redefine platinum-resistant ovarian cancer treatment, Corcept states.

## SEC filing metadata
- accession: 0001193125-25-199706
- form_type: 8-K
- ticker: CORT
- cik: 0001088856
- company_name: CORCEPT THERAPEUTICS INC
- filed_at: 2025-09-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1088856/000119312525199706/0001193125-25-199706-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1088856/000119312525199706/d947259d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-199706
- JSON: https://secwatch.observer/filing/0001193125-25-199706.json
- Plain text: https://secwatch.observer/filing/0001193125-25-199706.txt

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