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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
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.
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