secwatch.observer — SEC 8-K summary
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Issuer:     CORCEPT THERAPEUTICS INC (CORT)
CIK:        0001088856
Form:       8-K
Filed at:   2025-03-03T23:59:59+00:00
Accession:  0001193125-25-044123
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525044123/0001193125-25-044123-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525044123/d914293d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-044123

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