Clinical/Endpoint CRL, RGX-121 (MPS II): FDA cited uncertainty on study eligibility criteria, natural-history external-control comparability, and the surrogate endpoint (CSF HS D2S6).
Price into the decision (T-120)
Daily close, T-120 (8/22/25) through T+5. Run-up high $15.98 on 1/22/26, low $8.03 on 8/26/25 (T-120 to T-1). FDA decision 2/8/26. Historical price action, not a forecast.
Decision facts
FDA decision date2026-02-08
Outcome✗ CRL✓ source-verified
Decision-day move-0.2%
T-120 run-up (low→high)+52.0% ($8.5→$15.98)
CRL reasonClinical/Endpoint, RGX-121 (MPS II): FDA cited uncertainty on study eligibility criteria, natural-history external-control comparability, and the surrogate endpoint (CSF HS D2S6).
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.