LEQEMBI IQLIK (lecanemab-irmb) (at-home injection) was approved by the FDA on July 13, 2026 for early Alzheimer's disease.
LEQEMBI IQLIK (lecanemab-irmb) subcutaneous injection approved as an initiation (starting) dose for early Alzheimer's disease (Jul 13 2026).
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.
Primary source: Eisai / Biogen investor release, July 13, 2026
FDA record of the action: the FDA approved on July 13, 2026, per BLA 761375 SUPPL-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Perceptive Advisors | 276,173 | $59.7 million | filed August 14, 2026 |
| OrbiMed Advisors | 61,600 | $13.3 million | filed August 14, 2026 |
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.
Yes. The FDA approved the application for LEQEMBI IQLIK (lecanemab-irmb) (at-home injection) on July 13, 2026, per the FDA's own record. The primary source is linked on this page.
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.
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.