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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News
- Biogen Inc. (NASDAQ: BIIB) had its price target lowered by analysts at Mizuho from $251.00 to $207.00. They now have an "outperform" rating on the stock.MarketBeat
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- Biogen Inc. (NASDAQ: BIIB) was downgraded by analysts at Needham & Company LLC to a "hold" rating. They now have a $270.00 price target on the stock.MarketBeat
BIIB
Earnings
- 10/31/24 - Beat
BIIB
Sec Filings
- 11/12/24 - Form SC
- 11/7/24 - Form 4
- 11/4/24 - Form 4
- BIIB's page on the SEC website