pdufa.bio
HomeDecisions › MGNX 2026-04-08

MGNX FDA decision — Apr 8, 2026

✕ COMPLETE RESPONSE LETTER

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

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

PDUFA 4/8/26$3.43$1.3310/22/25
Daily close, T-120 (10/22/25) through T+5. Run-up high $3.43 on 3/11/26, low $1.33 on 12/15/25 (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)
CompanyMacroGenics Inc.
120-day run-up (T-120→T-1)+108.1%