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RGNX FDA decision — Feb 9, 2026

✕ COMPLETE RESPONSE LETTER

REGENXBIO Inc. — clemidsogene lanparvovec (RGX-121) - (CAMPSI · MPS II (Hunter Syndrome).

Run-up into the decision (T-120 → T+5)

PDUFA 2/9/26$15.98$8.038/25/25
Daily close, T-120 (8/25/25) 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 2/9/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-09
OutcomeCRL
Drug / candidateclemidsogene lanparvovec (RGX-121) - (CAMPSI
CompanyREGENXBIO Inc.
120-day run-up (T-120→T-1)+18.6%