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pdufa.bio

Cemiplimab

Updated ยทnext FDA decision on the calendar

Cemiplimab is a Regeneron Pharmaceuticals Inc. program. Its next catalyst is a Readout in Apr 2027. 1 FDA decision on record below. Every date links its source.

REGN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Cemiplimab is marketed as Libtayo (cemiplimab-rwlc); the events below include those tracked under the brand name. Sponsor: Regeneron Pharmaceuticals Inc. (REGN). We track 3 catalyst events for this program: 2 upcoming and 1 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 · Oct 8, 2025 ✓ ApprovedREGNReadout · Apr 2027REGNReadout · May 2027REGN

Questions

When is Cemiplimab's next FDA decision or readout?

The next tracked catalyst for Cemiplimab is a Readout in Apr 2027.

What happened at Cemiplimab's most recent FDA decision?

On Oct 8, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Cemiplimab?

Regeneron Pharmaceuticals Inc. (REGN).

Has Cemiplimab been approved by the FDA?

Yes. The FDA approved an application for Cemiplimab on Oct 8, 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.