LEQEMBI IQLIK (lecanemab-irmb) subcutaneous injection approved as an initiation (starting) dose for early Alzheimer's disease (Jul 13 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (1/16/26) through T+2. Run-up high $216.63 on 6/29/26, low $164.42 on 1/16/26 (T-120 to T-1). FDA decision 7/13/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-07-13
OutcomeApproved
Drug / candidateLEQEMBI IQLIK (lecanemab-irmb) (at-home injection)
IndicationEarly Alzheimer's disease
CompanyBiogen Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+21.1%
Cohort decision-day move (history)1.0% median (n=828)
The PDUFA goal date was August 24, 2026, itself a three-month extension announced May 8, 2026, after the FDA deemed additional information a major amendment to the sBLA. The FDA approved on July 13, 2026, about six weeks early. Subcutaneous maintenance dosing was approved separately on August 26, 2025; this decision covers the starting dose.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Was LEQEMBI IQLIK (lecanemab-irmb) (at-home injection) approved by the FDA?
Yes. The FDA approved the application for LEQEMBI IQLIK (lecanemab-irmb) (at-home injection) on July 13, 2026. The primary source is linked on this page.
Which company is behind LEQEMBI IQLIK (lecanemab-irmb) (at-home injection)?
LEQEMBI IQLIK (lecanemab-irmb) (at-home injection) is a Biogen Inc. (BIIB) program. The FDA decision came on July 13, 2026; the company's own announcement is linked on this page.
How did BIIB stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), BIIB moved +21.1%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.
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