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)
Historical price action; green = local high, red = low/sell-off.
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.