Efficacy CRL — GRADIENT (hypertension secondary to hypercortisolism) missed its primary endpoint; FDA found benefit–risk not established without more evidence (pivotal GRACE was positive).
Historical price action; green = local high, red = low/sell-off.
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.