pdufa.bio

LEQEMBI (lecanemab-irmb)

Updated ยทnext FDA decision on the calendar

LEQEMBI (lecanemab-irmb) 1 FDA decision on record below. Every date links its source.

BIIB 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 · Jan 26, 2025 ✓ ApprovedBIIB

Questions

When is LEQEMBI (lecanemab-irmb)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for LEQEMBI (lecanemab-irmb); 1 FDA decision is on record below.

What happened at LEQEMBI (lecanemab-irmb)'s most recent FDA decision?

On Jan 26, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has LEQEMBI (lecanemab-irmb) been approved by the FDA?

Yes. The FDA approved an application for LEQEMBI (lecanemab-irmb) on Jan 26, 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.