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Lynkuet (elinzanetant)

Updated ยทnext FDA decision on the calendar

Lynkuet (elinzanetant) 1 FDA decision on record below. Every date links its source.

BAYRY catalyst hub

About this program

We track 1 catalyst event for this program: 0 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 24, 2025 ✓ ApprovedBAYRY

Questions

When is Lynkuet (elinzanetant)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Lynkuet (elinzanetant); 1 FDA decision is on record below.

What happened at Lynkuet (elinzanetant)'s most recent FDA decision?

On Oct 24, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has Lynkuet (elinzanetant) been approved by the FDA?

Yes. The FDA approved an application for Lynkuet (elinzanetant) on Oct 24, 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.