Reported Earlier, Biogen And Eisai Initiated Rolling Biologics License Application With US FDA For Subcutaneous LEQEMBI (lecanemab-irmb) To Treat Early Alzheimer's Disease Under Fast Track Status
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Biogen and Eisai have initiated a rolling Biologics License Application with the US FDA for subcutaneous LEQEMBI to treat early Alzheimer's disease under Fast Track status. LEQEMBI is already approved in the U.S., Japan, and China, with applications submitted in multiple other countries. Eisai also submitted a Supplemental Biologics License Application for monthly intravenous maintenance dosing.
May 15, 2024 | 6:51 am
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Biogen, in collaboration with Eisai, has initiated a rolling Biologics License Application with the US FDA for subcutaneous LEQEMBI to treat early Alzheimer's disease under Fast Track status.
The initiation of a rolling Biologics License Application under Fast Track status is a significant regulatory milestone that could expedite the approval process, potentially boosting Biogen's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 80
POSITIVE IMPACT
Eisai, leading the development and regulatory submissions for LEQEMBI, has initiated a rolling Biologics License Application with the US FDA for subcutaneous LEQEMBI to treat early Alzheimer's disease under Fast Track status.
Eisai's role in leading the development and regulatory submissions for LEQEMBI, along with the Fast Track status, is likely to positively impact its stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 80