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    BIIB   US09062X1037

BIOGEN INC.

(BIIB)
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Delayed Nasdaq  -  04:00 2022-07-01 pm EDT
210.63 USD   +3.28%
06/24Biogen Terminates Alzheimer's Drug Aduhelm Study Over Coverage Limits
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Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway

05/09/2022 | 07:31pm EDT

Eisai Co., Ltd. and Biogen announced that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aß) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.


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All news about BIOGEN INC.
06/24Biogen Terminates Alzheimer's Drug Aduhelm Study Over Coverage Limits
MT
06/24BIOGEN INC.(NASDAQGS : BIIB) added to Russell Midcap Value Index
CI
06/24BIOGEN INC.(NASDAQGS : BIIB) dropped from Russell Top 200 Value Index
CI
06/24BIOGEN INC.(NASDAQGS : BIIB) dropped from Russell Top 200 Index
CI
06/24BIOGEN INC.(NASDAQGS : BIIB) added to Russell Midcap Index
CI
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MT
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06/22Biogen and Happify Health Collaborate to Support Multiple Sclerosis Patients on Digital..
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06/22Biogen and Happify Health Collaborates to Support Multiple Sclerosis Patients on Digita..
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06/21BIOGEN INC. : Change in Directors or Principal Officers, Submission of Matters to a Vote o..
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Financials (USD)
Sales 2022 9 831 M - -
Net income 2022 1 994 M - -
Net cash 2022 60,0 M - -
P/E ratio 2022 15,0x
Yield 2022 -
Capitalization 30 847 M 30 847 M -
EV / Sales 2022 3,13x
EV / Sales 2023 2,94x
Nbr of Employees 9 610
Free-Float 85,5%
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Mean consensus OUTPERFORM
Number of Analysts 32
Last Close Price 210,63 $
Average target price 242,78 $
Spread / Average Target 15,3%
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Managers and Directors
Michel Vounatsos Chief Executive Officer & Director
Michael R. McDonnell Chief Financial Officer & Executive Vice President
Stelios Papadopoulos Director
Alphonse Galdes EVP-Pharmaceutical Operations & Technology
Mahalakshmi Radhakrishnan Chief Medical Officer & Group Senior VP
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