secwatch.observer — SEC 8-K summary
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Issuer:     CORCEPT THERAPEUTICS INC (CORT)
CIK:        0001088856
Form:       8-K
Filed at:   2025-07-14T23:59:59+00:00
Accession:  0001193125-25-158454
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Corcept submits NDA for relacorilant as treatment for platinum-resistant ovarian cancer
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- NDA submitted to FDA for relacorilant plus nab-paclitaxel, based on Phase 3 ROSELLA and Phase 2 trials.
- Improved progression-free and overall survival vs nab-paclitaxel monotherapy; no biomarker selection needed.
- Relacorilant well-tolerated; adverse events similar to monotherapy, no increased safety burden.
- CEO notes this is Corcept's second NDA before FDA; relacorilant also under review for hypercortisolism.
- Company preparing launch once approved; oncology and endocrinology units in place.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525158454/0001193125-25-158454-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525158454/d940113d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-158454

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer