Relacorilant

Note: Corcept Q2 2026 8-K Ex-99.1, filed 2026-07-29, states verbatim: 'Relacorilant for patients with Cushing's syndrome - New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026', and in management commentary, 'We expect a decision on our NDA by December 17, 2026.' The resubmission itself was announced in an earlier Corcept 8-K Ex-99.1 dated 2026-06-17 (https://www.sec.gov/Archives/edgar/data/1088856/000119312526274258/d159941dex991.htm): 'resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for relacorilant as a treatment for patients with Cushing's syndrome. As requested by the FDA, the resubmission includes additional analyses of data included in the original NDA submission. Corcept expects the resubmission to receive a six-month review.' Six-month (Class 2) clock from 2026-06-17 lands on 2026-12-17, consistent. This RESTARTS the application our repo already tracks at pdufaDateISO 2026-12-30 (2025) with outcome 'crl' — it is a new review cycle, not a duplicate. It is also DISTINCT from relacorilant + nab-paclitaxel in platinum-resistant ovarian cancer, which was approved early as Lifyorli on 2026-03-25 against a 2026-07-11 target. Resubmission basis: pivotal Phase 3 GRACE plus the Phase 3 GRADIENT trial and the long-term extension study. DESIGNATIONS left empty deliberately: neither the 2026-06-17 nor the 2026-07-29 release restates an FDA expedited designation, and our older 2025-12-30 record's 'Orphan Drug' tag was not re-verified in this pass.