FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Revie...
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
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Source: Yahoo! Finance
FDA action date set for May 24, 2026 TOKYO and CAMBRIDGE, Mass. Jan. 25, 2026 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI ® ) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to admini
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- Biogen (NASDAQ:BIIB) had its "neutral" rating reaffirmed by analysts at Citigroup Inc..MarketBeat
- FDA Accepts LEQEMBI® IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority ReviewPR Newswire
- Biogen (NASDAQ:BIIB) had its price target raised by analysts at Wedbush from $143.00 to $178.00. They now have a "neutral" rating on the stock.MarketBeat
BIIB
Earnings
- 10/31/25 - Beat
BIIB
Sec Filings
- 1/14/26 - Form 8-K
- 12/3/25 - Form 4
- 11/13/25 - Form SCHEDULE
- BIIB's page on the SEC website