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EPKINLY (epcoritamab-bysp)

Updated ยทnext FDA decision on the calendar

EPKINLY (epcoritamab-bysp) 2 FDA decisions on record below. Every date links its source.

ABBV catalyst hub · GMAB 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 · Nov 18, 2025 ✓ ApprovedABBVPDUFA · Nov 18, 2025 ✓ ApprovedGMAB

Questions

When is EPKINLY (epcoritamab-bysp)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for EPKINLY (epcoritamab-bysp); 2 FDA decisions are on record below.

What happened at EPKINLY (epcoritamab-bysp)'s most recent FDA decision?

On Nov 18, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has EPKINLY (epcoritamab-bysp) been approved by the FDA?

Yes. The FDA approved an application for EPKINLY (epcoritamab-bysp) on Nov 18, 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.

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.
About · Corrections · Methodology

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