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LEQEMBI IQLIK (lecanemab-irmb)

Updated ยทnext FDA decision on the calendar

LEQEMBI IQLIK (lecanemab-irmb) The FDA approved it on Jul 13, 2026. 2 FDA decisions on record below. Every date links its source.

BIIB catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

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 · Aug 29, 2025 ✓ ApprovedBIIBPDUFA · 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); 2 FDA decisions are 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.

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

Yes. The FDA approved an application for LEQEMBI IQLIK (lecanemab-irmb) on Jul 13, 2026; 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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