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Zynyz (retifanlimab-dlwr)

Updated ยทnext FDA decision on the calendar

Zynyz (retifanlimab-dlwr) The FDA issued a Complete Response Letter on Apr 8, 2026. 3 FDA decisions on record below. Every date links its source.

INCY catalyst hub · MGNX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 3 catalyst events for this program: 0 upcoming and 3 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 · May 15, 2025 ✓ ApprovedINCYPDUFA · 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); 3 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.

Has Zynyz (retifanlimab-dlwr) been approved by the FDA?

Yes. The FDA approved an application for Zynyz (retifanlimab-dlwr) on May 15, 2025; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.