Eisai And Biogen Announced FDA Accepts Filing of LEQEMBI Supplemental Biologics License Application For IV Maintenance Dosing To Treat Early Alzheimer's Disease
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Eisai and Biogen announced that the FDA has accepted Eisai's Supplemental Biologics License Application for LEQEMBI IV maintenance dosing to treat early Alzheimer's disease. The PDUFA action date is set for January 25, 2025.
June 10, 2024 | 12:10 am
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Biogen's LEQEMBI IV maintenance dosing for early Alzheimer's disease has been accepted by the FDA, with a PDUFA action date set for January 25, 2025.
The acceptance of the sBLA by the FDA is a positive regulatory milestone for Biogen, potentially leading to an expanded market for LEQEMBI. This could positively impact Biogen's stock price in the short term.
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