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LEQEMBI IQLIK (lecanemab-irmb)

Updated ยทnext FDA decision on the calendar

LEQEMBI IQLIK (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 · Jul 13, 2026 ✓ ApprovedBIIB

Questions

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

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

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

On Jul 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.