secwatch.observer — SEC 8-K summary
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Issuer:     CORCEPT THERAPEUTICS INC (CORT)
CIK:        0001088856
Form:       8-K
Filed at:   2025-09-10T23:59:59+00:00
Accession:  0001193125-25-199706
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525199706/0001193125-25-199706-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1088856/000119312525199706/d947259d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-199706

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