secwatch.observer — SEC 8-K summary
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Issuer:     CORCEPT THERAPEUTICS INC (CORT)
CIK:        0001088856
Form:       8-K
Filed at:   2025-12-31T23:59:59+00:00
Accession:  0001193125-25-338184
Event type: regulatory
Sentiment:  negative
Materiality: 0.78
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/0001193125-25-338184-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525338184/d50993d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-338184

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