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Biogen Gets FDA Nod For Controversial Alzheimer's Drug; First Treatment Approval For The Disease In 18 Years
Monday, June 7, 2021 - 11:37am | 535After months of wait, Biogen Inc. (NASDAQ: BIIB) has finally achieved success by taking its controversial Alzheimer's treatment past the finish line. FDA Okays Aducanumab: Biogen's biologic license application for aducanumab, its investigational Alzheimer's treatment, received FDA...
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Biogen Shares Jump After FDA Delays Aducanumab Decision By 3 Months
Friday, January 29, 2021 - 10:15am | 321Biogen Inc (NASDAQ: BIIB) shares are up sharply Friday after the company announced a delay in the FDA decision for its Alzheimer's treatment candidate, aducanumab. What Happened: The FDA has extended the review period for the biologic license application for aducanumab by three months, Biogen...
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Analysts Predict Volatility In Biogen Shares Until March 2021
Monday, November 9, 2020 - 6:51am | 525Wall Street analysts suggest that Biogen Inc (NASDAQ: BIIB) stock is about to see a significant selloff and could witness volatility until the Food and Drugs Administration (FDA) review process comes to a close in March 2021, Bloomberg reports. The analyst forecasts were...
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Biogen's Aducanumab Fails To Win FDA Panel Backing
Friday, November 6, 2020 - 6:04pm | 451Biogen Inc (NASDAQ: BIIB) failed to win the backing of the FDA panel which reviewed the BLA for its controversial Alzheimer's drug aducanumab, an antibody which targets amyloid-beta. What Happened: FDA's Peripheral and Central Nervous System Drugs Advisory Committee met Friday to...
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Biogen Surges On Favorable FDA Briefing Doc For Alzheimer's Candidate
Wednesday, November 4, 2020 - 12:48pm | 539Biogen Inc (NASDAQ: BIIB) shares were soaring Wednesday in reaction to an FDA briefing document released ahead of Friday's Adcom meeting on the investigational Alzheimer's drug aducanumab, an amyloid beta-targeting antibody. What Happened: The Study 302 that evaluated aducanumab...
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Biogen Soars As FDA Accepts Alzheimer's Drug For Review In 'Next Stage Of Aducanumab Saga'
Friday, August 7, 2020 - 11:40am | 593Biogen Inc's (NASDAQ: BIIB) investigational Alzheimer's drug aducanumab — a drug for which the company halted studies at one point last year — could finally see the light of day. What Happened: The FDA accepted the aducanumab biologics license application for priority...
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Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing Delay
Thursday, April 23, 2020 - 3:49pm | 785Biogen Inc (NASDAQ: BIIB) shares shed close to 10% Wednesday following the revelation that the BLA filing for the company's Alzheimer's investigational drug aducanumab will be delayed. The Biogen Analysts Barclays analyst Carter Gould maintained an Overweight rating on Biogen...
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Biogen Delays Regulatory Filing For Approval Of Alzheimer's Drug, Shares Slump
Wednesday, April 22, 2020 - 10:23am | 368Biogen Inc (NASDAQ: BIIB) shares were under pressure Wednesday following the release of the biotech's first-quarter report, including the statement that Biogen's BLA filing for its Alzheimer's drug will be delayed. Issuing an update on the regulatory filing for the Alzheimer's...
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Biogen's Alzheimer's Drug Has 'Decent Shot' At FDA Approval, Analyst Says
Monday, January 27, 2020 - 12:18pm | 403Despite the controversy surrounding Biogen Inc's (NASDAQ: BIIB) Alzheimer's drug trial results and skepticism concerning its approvability, an analyst at Canaccord Genuity sounds upbeat. The Analyst Sumant Kulkarni upgraded Biogen from Hold to Buy and increased the price target from $305 to...
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Biogen Analysts Divided Over Alzheimer's Drug Following CTAD Presentation
Friday, December 6, 2019 - 10:55am | 691Following Biogen Inc's (NASDAQ: BIIB) presentation of detailed top-line results for aducanumab at the Alzheimer's conference, the stock ended Thursday's session up about 3.5%. The presentation polarized analysts and clinicians alike, stirring a debate on whether the data is sufficient...
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Biogen's CTAD Presentation On Aducanumab Elicits Mixed Response
Thursday, December 5, 2019 - 3:01pm | 594Biogen Inc's (NASDAQ: BIIB) presentation of aducanumab data at the Clinical Trials On Alzheimer's Disease Congress has drawn a mixed response. In late October, Biogen announced plans to revive its Alzheimer's program following a new analysis conducted by the company in consultation...
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Biogen's Alzheimer's Drug 'Falls Far Short Of Compelling Argument For Approval,' Baird Says In Downgrade
Monday, December 2, 2019 - 2:55pm | 413Biogen Inc (NASDAQ: BIIB) shares gained more than 25% earlier this year when the company said it planned a regulatory filing for its Alzheimer's drug aducanumab following a new data analysis. Ahead of the Dec. 5 presentation of aducanumab data at the Clinical Trials on Alzheimer'...
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Cramer Makes The Case Why Biogen's Stock Could Double In Value
Thursday, October 31, 2019 - 1:57pm | 350Biotech company Biogen Inc (NASDAQ: BIIB)'s once-failed Alzheimer's drug, aducanumab, re-emerged Oct. 22, and this creates a path for the stock to double in size, according to CNBC's Jim Cramer. What Happened Biogen resumed testing aducanumab, and results from a larger dataset in...
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Biogen Analysts Debate About-Face On Aducanumab: 'Path To Market An Uphill Battle'
Wednesday, October 23, 2019 - 11:37am | 929Biogen Inc (NASDAQ: BIIB) shares rallied strongly Tuesday after the biotech said it plans a regulatory filing for its Alzheimer's drug aducanumab, which the company had written off back in March. The Analysts Morgan Stanley analyst Matthew Harrison maintained an Underweight rating on...
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Analysts Digest Biogen's Alzheimer's Disappointment: 'There Isn't Much To Be Excited About'
Friday, March 22, 2019 - 1:30pm | 595Biogen Inc (NASDAQ: BIIB) shares plunged nearly 30 percent Thursday after, along with development partner Eisai Co., Ltd (OTC: ESALY) announced the decision to scrap two late-stage trials evaluating their Alzheimer's candidate aducanumab. The Analysts Mizuho Securities analyst Salim Syed...