Biogen Inc (BIIB.O) Key Developments | Reuters.com
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Biogen Inc (BIIB.O)

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Latest Key Developments (Source: Significant Developments)

Biogen's Alzheimer drug Aducanumab Accepted into EMA's PRIME Program
Wednesday, 1 Jun 2016 11:45am EDT 

Biogen Inc : Biogen's Investigational Alzheimer's Disease Treatment Aducanumab Accepted Into European Medicines Agency's Prime Program .Through Prime Program Biogen Will Have Access To Enhanced Support From EMA.  Full Article

U.S. FDA approves Zinbryta to treat multiple sclerosis
Friday, 27 May 2016 06:17pm EDT 

U.S. FDA : Approves Zinbryta to treat multiple sclerosis . Zinbryta has a boxed warning & is available only through a restricted distribution program under a risk evaluation and mitigation strategy . Boxed warning on Zinbryta tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events .Additional highlighted warnings include hypersensitivity reactions increased risk of infections,symptoms of depression,suicidal ideation.  Full Article

Regenxbio and Biogen enter agreement for development of gene therapy treatments
Monday, 16 May 2016 07:00am EDT 

Regenxbio Inc : Regenxbio and Biogen enter exclusive license agreement for the development of gene therapy treatments for rare genetic vision disorders . Under terms, Biogen granted worldwide research license to co's NAV AAV8,AAV9 vectors for development of gene therapy product candidates .Co will receive undisclosed upfront payment, ongoing fees, milestone payments and royalties on net sales of products.  Full Article

Biogen Inc announces intent to spin off its Hemophilia Business
Tuesday, 3 May 2016 07:30am EDT 

Biogen Inc:Says intends to spin off its hemophilia business as an independent, publicly traded company.Says new company, to be named at a later date, will focus on the discovery and development of therapies for the treatment of hemophilia.New company plans to bring longer acting therapies utilizing the XTEN technology into clinical development in the first half of 2017.Board of directors has authorized management to proceed with a plan to spin off its hemophilia business.Spin-off is planned to be completed by the end of 2016 or early 2017.  Full Article

Swedish Orphan Biovitrum publ AB and Biogen receive positive opinion from CHMP for Alprolix
Friday, 26 Feb 2016 07:11am EST 

Swedish Orphan Biovitrum publ AB and Biogen:Co and Biogen receive positive opinion from CHMP for Alprolix for treatment of Hemophilia B.Received a positive opinion from committee for medicinal products for human use of European medicines agency.Positive opinion recommends marketing authorisation be granted for alprolix for the treatment of hemophilia b.  Full Article

Biogen Inc gives FY 2016 guidance
Wednesday, 27 Jan 2016 07:15am EST 

Biogen Inc:Expects FY 2016 revenue to be about $11.1 to $11.3 billion.Expects FY 2016 non-GAAP diluted EPS to be between $18.30 and $18.60.Expects FY 2016 GAAP diluted EPS to be between $16.85 and $17.15.  Full Article

Arsia Therapeutics Inc. and Biogen sign research collaboration for development of subcutaneous biologics
Wednesday, 16 Dec 2015 07:00am EST 

Arsia therapeutics inc and Biogen:Arsia therapeutics inc - arsia will receive an upfront payment and could be eligible to receive development, regulatory, launch and sales milestones.Arsia therapeutics inc - arsia eligible to receive sales milestones of up to $100 million if multiple products are successfully commercialized.Arsia therapeutics inc - as part of the collaboration, Biogen will also utilize arsia's patented formulation technology.  Full Article

Biogen Inc to cut 11 pct of staff, cancel some drug programs; stock jumps - Reuters
Wednesday, 21 Oct 2015 12:58pm EDT 

Biogen Inc:Biogen Inc, whose shares have tumbled since it slashed growth forecasts for its top-selling multiple sclerosis drug in July, said it will cut 11 percent of its workforce and eliminate development of several drugs to focus on high-priority medicines in its pipeline - RTRS.The restructuring, announced on Wednesday, will reduce operating expenses by about $250 million this year, it said - RTRS.  Full Article

Biogen says Ascend late-stage trial did not meet primary, secondary endpoints
Wednesday, 21 Oct 2015 07:31am EDT 

Biogen:reports top-line results from phase 3 study evaluating natalizumab in secondary progressive MS.Says ascend phase 3 trial did not meet primary and secondary endpoints.Says natalizumab demonstrated statistically significant effect on upper limb function in patients.Says natalizumab was generally well tolerated and adverse events were consistent with its known safety profile.  Full Article

Biogen Inc raises FY 2015 guidance
Wednesday, 21 Oct 2015 07:30am EDT 

Biogen Inc:Expects FY 2015 revenue growth to be about 8 pct. to 9 pct. compared to 2014, a modest increase versus prior guidance.Expects FY 2015 Non-GAAP diluted EPS to be between $16.20 and $16.50, an increase from prior guidance.Expects FY 2015 GAAP diluted EPS to be between $14.65 and $14.95, an increase from prior guidance.  Full Article

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