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.
Decision facts
FDA decision date2025-12-31
Outcome✗ CRL✓ source-verified
Decision-day move-50.4%
T-120 run-up (low→high)+30.0% ($34.8→$90.32)
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)2.2% median (n=229)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.