BioArctic AB (BRCTF) announced on Monday that its partner Eisai (ESALY) has received Priority Review from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics License Application (sBLA) for the Leqembi Iqlik subcutaneous autoinjector.
The Prescription Drug User Fee Act (PDUFA) action date is set for May 24, 2026.
Leqembi is currently approved in more than 50 countries and regions for the treatment of early Alzheimer's disease.
If approved, the Leqembi Iqlik subcutaneous (SC) autoinjector could provide an alternative to the current intravenous (IV) dosing method.
The sBLA is supported by positive data from the Phase 3 Clarity Alzheimer's disease open-label extension (OLE) study, which evaluated SC administration of lecanemab across various doses.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.