Monitor for FDA acceptance of the resubmission and subsequent PDUFA date assignment, expected within 30 days. If accepted, a decision by late 2026 would be the next major catalyst. The stock has a history of strong positive reactions to regulatory progress on relacorilant.
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Executive Summary
Corcept Therapeutics resubmitted its New Drug Application (NDA) to the FDA for relacorilant as a treatment for Cushing's syndrome, including additional analyses requested by the agency. The NDA is based on positive Phase III data from the GRACE and GRADIENT trials, and the company expects a six-month review. This represents a key step toward potential label expansion for a drug already approved in ovarian cancer, but approval is not guaranteed.
Key Facts
- NDA for relacorilant (Cushing's syndrome) resubmitted to FDA on June 17, 2026.
- Resubmission includes additional analyses of prior data as requested by the FDA.
- Corcept expects a six-month review cycle (~6 months).
- Positive data from pivotal GRACE trial, Phase III GRADIENT trial, and long-term extension study support the NDA.
Financial Impact
Not specified
Risk Factors
- FDA may request additional clinical data or deny approval.
- Competition from existing Cushing's therapies (e.g., Korlym, Isturisa) may limit market share.
- Six-month review timeline could extend if FDA issues a complete response letter.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-274258 |
| Document: d159941dex991.htm | 0001193125-26-274258 |
| Document: 0001193125-26-274258-index-headers.html | 0001193125-26-274258 |
| Document: 0001193125-26-274258-index.html | 0001193125-26-274258 |
| Document: 0001193125-26-274258.txt | 0001193125-26-274258 |
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Aug 28, 2026 5w ago | Insider Cluster | $113.88 $115.63 | ▲ +1.54% | ▲ +1.28% | $116.49 (+2.29%) |
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