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INCY FDA decision — Apr 8, 2026

✕ COMPLETE RESPONSE LETTER

Incyte Corporation — ZYNYZ (retifanlimab-dlwr) - (POD1UM-304) · Non-small cell lung cancer (NSCLC).

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

PDUFA 4/8/26$110.57$85.9610/22/25
Daily close, T-120 (10/22/25) through T+5. Run-up high $110.57 on 1/12/26, low $85.96 on 10/22/25 (T-120 to T-1). FDA decision 4/8/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-08
OutcomeCRL
Drug / candidateZYNYZ (retifanlimab-dlwr) - (POD1UM-304)
CompanyIncyte Corporation
120-day run-up (T-120→T-1)+9.0%
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