Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies
Biogen Inc. (BIIB)
Last biogen inc. earnings: 4/22 07:12 am
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Source: GlobeNewswire
New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints Based on discussions with the FDA, the Company plans to submit a Biologics License Application in early 2020 Biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies The positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis CAMBRIDGE, Mass. and TOKYO, Oct. 22, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that, after consulting with the U.S. Food and Drug Administration (FDA), Biogen plans to pursue regulatory approval for aducanumab, an
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- Biogen Reports Progress on Corporate Responsibility PrioritiesGlobeNewswire
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BIIB
Earnings
- 4/25/24 - Beat
BIIB
Sec Filings
- 5/3/24 - Form 4
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- BIIB's page on the SEC website