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ZYNYZ (retifanlimab-dlwr)

Updated ยทnext FDA decision on the calendar

ZYNYZ (retifanlimab-dlwr) 2 FDA decisions on record below. Every date links its source.

INCY catalyst hub · MGNX catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Apr 8, 2026 CRLINCYPDUFA · Apr 8, 2026 CRLMGNX

Questions

When is ZYNYZ (retifanlimab-dlwr)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for ZYNYZ (retifanlimab-dlwr); 2 FDA decisions are on record below.

What happened at ZYNYZ (retifanlimab-dlwr)'s most recent FDA decision?

On Apr 8, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.