Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
The FDA's own letter · Complete Response Letter, NDA 219398 (PDF), dated January 28, 2026 (a corrected letter; it states the action date remains December 30, 2025), released under FDA's CRL transparency program. The company announced the decision on December 31, 2025; the FDA acted on December 30, 2025.
What the letter says has to be fixed (the letter's own section headings; read against the PDF, not openFDA's OCR text):
Clinical and statistical: substantial evidence of effectiveness. The two phase 3 trials do not demonstrate effectiveness for the proposed indication. CORT125134-455 met its primary endpoint but in a highly enriched population: of 102 subjects with baseline hypertension, 40 (39%) discontinued during the open-label phase and only 46 (45%) entered the randomized-withdrawal phase, so the observed effect 'likely overestimates the treatment effect'. CORT125134-456 did not meet its primary endpoint (between-arm difference in 24-hour systolic blood pressure -0.85 mmHg, 95% CI -6.7 to 4.9, p = 0.77); a post-hoc subgroup analysis was not pre-specified, was small, had substantial missing data, and did not reach nominal significance under FDA's own imputation. FDA states it had told the sponsor at pre-submission meetings to expect significant review issues.
Benefit-risk assessment: drug-induced liver injury. With effectiveness not demonstrated, no final benefit-risk assessment could be made. FDA's safety review concluded relacorilant is associated with drug-induced liver injury: four cases assessed as probable DILI, one with an ALT of 1,952 U/L (more than 50 times the upper limit of normal), with no alternative etiology identified.
The application under review is Corcept's resubmission of this NDA, with a PDUFA goal date of December 17, 2026. The letter is the FDA's statement of what the resubmission has to answer.
Efficacy CRL, GRADIENT (hypertension secondary to hypercortisolism) missed its primary endpoint; FDA found benefit-risk not established without more evidence (pivotal GRACE was positive).
Price into the decision (T-120)
Daily close, T-120 (7/16/25) through T+5. Run-up high $90.32 on 10/9/25, low $67.17 on 8/5/25 (T-120 to T-1). FDA decision 12/31/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 17, 2025, 14 days before the decision date, at-the-money options priced a move of ±32.0% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 140%). The stock closed -50.4% at the first close across the decision and -47.3% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
CRL reasonEfficacy, GRADIENT (hypertension secondary to hypercortisolism) missed its primary endpoint; FDA found benefit-risk not established without more evidence (pivotal GRACE was positive).
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMid
Cohort decision-day move (history)2.3% median (n=251)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was Relacorilant approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Relacorilant in its current form, was announced on December 31, 2025. A CRL is not final; the primary source is linked on this page.
How did CORT stock react to the FDA decision?
On the decision day CORT moved -50.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.