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Home › PDUFA Calendar › BIIB

BIIB PDUFA Date: LEQEMBI IQLIK (lecanemab-irmb)(at-home injection)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on July 13, 2026. Decision page with the source and measured reaction.
FDA decision Approved July 13, 2026 · Biogen Inc. · Early Alzheimer's disease (AD) a-home injection
More CNS & Neurology FDA decisions →All August 2026 PDUFA dates →

The story

LEQEMBI IQLIK (lecanemab-irmb)(at-home injection) was approved by the FDA on July 13, 2026 to treat Early Alzheimer's disease (AD) a-home injection.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNRXP . 2026-07-29Same area: Neurology . KETAFREELNTH-florquinitau . 2026-08-13Same area: Neurology . Florquinitau (MK-6240)MRNA . 2026-08-05Same month decision . mRNA-1010
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

BIIB run-up into the PDUFA (last ~120 days)

$204.53$172.34
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved July 13, 2026
Drug / candidateLEQEMBI IQLIK (lecanemab-irmb)(at-home injection)
IndicationEarly Alzheimer's disease (AD) a-home injection
CompanyBiogen Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT03887455 · active

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FAQ

What did the FDA decide on BIIB's LEQEMBI IQLIK (lecanemab-irmb)(at-home injection)?
The FDA decided BIIB's (Biogen Inc.) application for LEQEMBI IQLIK (lecanemab-irmb)(at-home injection) on July 13, 2026: Approved. pdufa.bio does not hold a sponsor-disclosed goal date for this application. Verify against the linked primary source.
What is BIIB's drug LEQEMBI IQLIK (lecanemab-irmb)(at-home injection)?
LEQEMBI IQLIK (lecanemab-irmb)(at-home injection) is Biogen Inc.'s drug, approved by the FDA on July 13, 2026 for Early Alzheimer's disease (AD) a-home injection.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.