BIIB - Biogen Inc.

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
278.14
-6.07 (-2.14%)
At close: 4:00PM EST
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Previous Close284.21
Open284.21
Bid277.77 x 800
Ask281.99 x 1800
Day's Range277.36 - 284.70
52 Week Range215.78 - 338.87
Volume1,028,927
Avg. Volume1,722,241
Market Cap50.188B
Beta (5Y Monthly)N/A
PE Ratio (TTM)9.95
EPS (TTM)N/A
Earnings DateJan 29, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est304.57
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    The one value strategy that wasn’t a disaster now favors commodity sector over techs

    There was one value strategy that wasn’t a disaster in 2019, and it now likes commodity producers over techs.

  • Roche's Risdiplam Meets Primary Endpoint in Infants Study
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    Roche's Risdiplam Meets Primary Endpoint in Infants Study

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  • Reuters

    Roche's risdiplam meets primary endpoint in trial of SMA drug in infants

    Roche's risdiplam met the primary endpoint in a pivotal clinical trial in infants with type 1 spinal muscular atrophy, the Swiss drugmaker said on Thursday. The treatment demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA, it said in a statement. Roche said this month it plans to price risdiplam aggressively to challenge two of the world's most expensive medicines, Biogen's Spinraza and Novartis's gene therapy Zolgensma.

  • Novartis (NVS) Gets Approval for MS Drug Mayzent in Europe
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    Novartis (NVS) Gets Approval for MS Drug Mayzent in Europe

    Novartis' (NVS) MS drug, Mayzent, obtains approval in Europe for the treatment of adult patients with secondary progressive multiple sclerosis.

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  • FDA Risks Sacrificing Its Standards for Speed
    Bloomberg

    FDA Risks Sacrificing Its Standards for Speed

    (Bloomberg Opinion) -- Today’s Food and Drug Administration moves much faster than it used to. That may not always be a good thing. A review of drug approvals by the agency from researchers at Harvard Medical School released Tuesday found that the FDA is approving drugs more rapidly with weaker evidence than it did in the past. That can be beneficial when it leads to needed medicines getting to market quickly, and I believe that’s the agency’s intent. As the study’s authors highlight, however, this emphasis on speed and flexibility could be eroding standards. It may be time for a gut check.The gold standard for demonstrating efficacy — and the surest way of winning drug approval — is to demonstrate success in large, well-controlled studies that result in a hard outcome. But there are faster ways to get to market. In 1992, Congress created the accelerated approval program, which can green light medicines based on “surrogate” endpoints that predict rather than confirm benefit for patients, or those that have shown a shorter-term benefit. It’s one of several initiatives that have changed how the agency works. According to the study, 80.6% of approvals between 1995 and 1997 were supported by at least two pivotal trials. That number dropped to 52.8% between 2005 and 2017. Companies that get accelerated approval have to prove their drug works with a confirmatory trial in order to gain full approval, but there’s no hard timetable no when that must be done. Thus, drugmakers often don't hurry to conduct those tests. This is problematic at best, dangerous at worst.Here’s just one case: In 2016, Sarepta Therapeutics Inc. sought approval of a medicine to treat a rare muscle-wasting disease in young boys based on weak evidence from a tiny trial. In the face of significant public pressure, the FDA approved Exondys 51 even though one of its scientists called the treatment “an elegant placebo” in a report. Sarepta is selling the drug for over $300,000 a year but has continually delayed a confirmatory trial. It’s now years away from completion, and there have been no real consequences for the delay.When companies do complete post-approval trials, it sometimes reveals a mistake. Eli Lilly & Co.’s cancer drug Lartruvo got accelerated approval in 2016. Lilly then pulled the medicine from the market last year after a larger trial found no benefit. That’s a rare outcome, but there are many expensive drugs on the market that have never moved beyond surrogate endpoints. A study of 93 accelerated cancer drug approvals between 1992 and 2017 found that only 19 had proved to help patients live longer in a followup trial. There are some good reasons for faster approvals, as former FDA Commissioner Scott Gottlieb outlined in a Twitter response this week to a critical New York Times editorial penned on Jan. 11. Scientists are better at evaluating the safety of medicines and trial design has improved, for example. And advances have made it easier to create drugs that target small populations and have dramatic effects, Gottlieb wrote.He makes good points. But the agency arguably hasn’t found the right balance between embracing advances and maintaining a high bar. It certainly has a ways to go on post-approval follow up. America is entirely unable to control the price of new medicines; the approval of marginal drugs has financial consequences. The FDA will soon face one of its most important and controversial decisions yet. Biogen Inc. is seeking approval for the first purportedly disease-modifying Alzheimer’s drug — a medicine that could be used by millions of people and cost billions — without good evidence that it works. The agency often uses unmet need as a justification for shifting standards, and there’s no bigger unmet need than Alzheimer’s. That doesn’t justify an approval based on one failed trial and another that is a questionable success at best.The agency will have to decide whether to review or approve the medicine in the next year or so. This choice is an opportunity to resist public pressure and move back toward demanding firmer proof of efficacy before drugs hit the market. To contact the author of this story: Max Nisen at mnisen@bloomberg.netTo contact the editor responsible for this story: Beth Williams at bewilliams@bloomberg.netThis column does not necessarily reflect the opinion of Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinionSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

  • MoneyShow

    Top Picks 2020- Ionis Pharmaceuticals IONS

    The R&D; pipeline at Ionis Pharmaceuticals (IONS) is unsurpassed, we believe, by most leading biotech and even global drug companies, suggests biotech expert Jay Silverman, contributing editor to The Medical Technology Stock Letter.

  • 4 High-Quality Health Care Companies for 2020
    GuruFocus.com

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  • Alexion pushes 'high-risk, high-reward' ALS strategy amid competitive pressure
    American City Business Journals

    Alexion pushes 'high-risk, high-reward' ALS strategy amid competitive pressure

    With competition encroaching, Alexion executives are pushing plans to more than double the company’s product portfolio in the next three years, including at least one “high risk, high reward” drug candidate.

  • Moody's

    Biogen Inc. -- Moody's announces completion of a periodic review of ratings of Biogen Inc.

    Announcement of Periodic Review: Moody's announces completion of a periodic review of ratings of Biogen Inc. New York, January 14, 2020 -- Moody's Investors Service ("Moody's") has completed a periodic review of the ratings of Biogen Inc. and other ratings that are associated with the same analytical unit. The review was conducted through a portfolio review in which Moody's reassessed the appropriateness of the ratings in the context of the relevant principal methodology(ies), recent developments, and a comparison of the financial and operating profile to similarly rated peers.

  • Biogen Acquires Early-Stage CNS Drug From Pfizer for $75M
    Zacks

    Biogen Acquires Early-Stage CNS Drug From Pfizer for $75M

    Biogen (BIIB) signs deals with Pfizer to acquire rights to a CNS candidate and develop it as potential therapy to treat certain symptoms/disorders related to Alzheimer's disease and Parkinson's disease.

  • Benzinga

    Benzinga Pro's Top 5 Stocks To Watch For Mon., Jan. 13, 2020: WCC, LULU, XLF, TEAM, BIIB

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  • MarketWatch

    Biogen to buy from Pfizer an asset to develop into potential Alzheimer's, Parkinson's treatments

    Biogen Inc. said Monday it will buy from Pfizer Inc. a potential treatment for behavioral and neurological symptoms, as a potential treatment for Alzheimer's and Parkinson's, for an upfront payment of $75 million and up to $635 million in potential milestone payments. The asset is a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for use across various pychiatric and neurological diseases. Biogen plans to develop the asset for the treatment of Sundowning in Alzheimer's disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson's disease. "Many patients with Alzheimer's and Parkinson's suffer from debilitating sleep disorders and agitation, and we believe that the regulation of the circadian rhythm may hold promise in addressing these challenging behavioral and neurological symptoms," said Alfred Sandrock, chief medical officer at Biogen. Pfizer's stock rose 0.5% in premarket trading while Biogen shares fell 0.9%. Over the past three months, Pfizer's stock has gained 9.4% and Biogen shares have soared 32.8%, while the Dow Jones Industrial Average has advanced 7.5%.

  • GlobeNewswire

    Biogen to Acquire Novel Clinical Stage Asset with Application in Alzheimer’s Disease and Parkinson’s Disease from Pfizer Inc.

    Biogen Inc. (BIIB) today announced an agreement to acquire from Pfizer Inc. (PFE) PF-05251749, a novel CNS-penetrant small molecule inhibitor of casein kinase 1 (CK1), for the potential treatment of patients with behavioral and neurological symptoms across various psychiatric and neurological diseases. In particular, Biogen plans to develop the Phase 1 asset for the treatment of Sundowning in Alzheimer’s disease (AD) and Irregular Sleep Wake Rhythm Disorder (ISWRD) in Parkinson’s disease (PD).

  • Barrons.com

    Biogen Defends Its Blockbuster Against Mylan’s Patent Challenge

    The biotech has already seen its shares buffeted by issues with an experimental Alzheimer’s drug. Now it faces a decision that could hasten generic producers taking a bite out of 40% of its revenues.

  • American City Business Journals

    Biogen signs neuro disease drug deal with Cambridge startup

    A young biotech startup hoping to map out the actions of cells throughout the body has signed its second major drug development partner with biotech giant Biogen.

  • Barrons.com

    4 Things to Pay Attention to at the J.P. Morgan Health-Care Conference Next Week

    Starting Monday, executives and investors in the biotech, pharmaceutical, and medical-device sectors, among others, gather in San Francisco for J.P. Morgan’s annual health-care conference.

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  • Behind the Seizure® Program Further Expands Access to Genetic Testing for Children to Speed the Diagnosis of Genetic Epilepsy
    PR Newswire

    Behind the Seizure® Program Further Expands Access to Genetic Testing for Children to Speed the Diagnosis of Genetic Epilepsy

    Today BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Invitae Corporation (NYSE: NVTA) announced that Biogen (NASDAQ: BIIB), Encoded Therapeutics, Neurogene, Praxis Precision Medicines and PTC Therapeutics joined Behind the Seizure®, an innovative, cross-company collaboration that aims to provide faster diagnosis for young children with epilepsy. The program will also be expanded to make no-charge testing available for healthcare providers to order for any child under the age of eight who has an unprovoked seizure.

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  • Is Biogen Stock A Buy On Renewed Hope In Alzheimer's Disease?
    Investor's Business Daily

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    Biogen stock popped in mid-October after the biotech company said a broader analysis showed some promise for its Alzheimer's treatment, aducanumab. Is now the time to buy Biogen stock?

  • Barrons.com

    Biogen Faces a Looming Patent Decision. Here’s How Much Its Stock Could Drop If It Loses.

    Multiple sclerosis treatment Tecfidera has been Biogen’s top seller since 2015. If the patent holds up, the company could maintain exclusivity until early 2028.

  • Barrons.com

    Drug-Price Increases Show Business as Usual Despite Public Pressure

    The new year began with a flurry of increases from companies such as Gilead Sciences, Biogen, and Pfizer.

  • TheStreet.com

    Bristol-Myers, Gilead, Biogen, Other Drugmakers Increased U.S. List Prices on Jan. 1: Report

    Nearly all the price increases were less than 10%, with the median rise around 5%, a media report said.