|Bid||300.12 x 1100|
|Ask||300.36 x 800|
|Day's Range||299.68 - 304.56|
|52 Week Range||215.78 - 344.00|
|Beta (3Y Monthly)||1.06|
|PE Ratio (TTM)||10.74|
|Earnings Date||Jan 27, 2020 - Jan 31, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||301.32|
CEO Michel Vounatsos says if the drug is approved it will require new payment innovations to make it affordable for the people who need it.
Analysts offered split views of Biogen's controversial Alzheimer's treatment on Friday after the biotech company suggested a high dose of the drug works. Biogen stock rose midday Friday.
An Alzheimer’s disease expert said Biogen “absolutely” needs to conduct a third clinical trial for aducanumab, its now controversial and recently resurrected Alzheimer’s disease drug candidate.
The stock rose after company scientists presented a new analysis of Alzheimer’s drug tests that management thinks will convince regulators that the treatment works.
Shares of Cassava Sciences Inc. jumped 24% on positive data from a mid-stage trial for its experimental Alzheimer's disease drug, PTI-125. The data, which found that the therapy reduced cerebrospinal fluid and plasma biomarkers for Alzheimer's, was released Dec. 5 at the Clinical Trials on Alzheimer's Disease meeting in San Diego. Biogen also released somewhat controversial data about its late-stage Alzheimer's candidate at the conference on Thursday. Cassava stock is up 163% year-to-date. The S&P 500 is up 25%.
PiperJaffrey analyst Christopher Raymond wrote that health-care/biotech-focused funds saw a second week of inflows as stocks including Biogen and Amgen are having great fourth quarters.
Following 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%. Cantor Fitzgerald analyst Alethia Young maintained a Neutral rating and $300 price target. Raymond James analyst Steven Seedhouse reiterated a Market Perform rating.
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?
Biotech giant Biogen Inc. created what one attendee called an “electric atmosphere” at an industry conference Thursday when it presented new data from its controversial and potentially industry-changing Alzheimer’s disease drug.
(Bloomberg) -- Shares of Japanese drugmaker Eisai Co. and partner Biogen Inc. got a boost after the U.S. company said it plans to resume previous studies of their once-abandoned treatment for Alzheimer’s disease.Biogen rolled out detailed trial data at the Clinical Trials on Alzheimer’s Disease conference in San Diego on Thursday, marking a climax in a months-long saga that has seen patients’ hopes dashed and revived.Eisai shares climbed as much as 5% in early trading in Tokyo on Friday. Biogen initially plummeted in New York trading Thursday, and then rebounded to close 3.4% higher.It was the first in-depth look at the experimental treatment, known as aducanumab, since the companies revived it in October. In March, Biogen and Eisai, who have been collaborating on the drug for several years, declared two studies of the medicine failures and abandoned the drug. Eisai lost $8 billion in market capitalization over two trading days following the news.But executives said on Thursday that additional data showed the infusion, if given long enough and at high doses, could offer some benefit.“This could represent the first treatment that targets a core pathology and open an era of precision medicine for Alzheimer’s disease,” said Stephen Salloway, a Brown University professor who was part of a panel that discussed the results at the conference. “This is a milestone achievement for our field.”What Bloomberg Intelligence Says:Biogen’s updated data for aducanumab Phase III trials at the CTAD conference doesn’t convince us that they will be sufficient for regulatory approval. Rather, we believe the data are intriguing and suggestive of a need for a new Phase III trial at the higher 10mg dose. The drug’s efficacy needs solid proof, given that its side-effect profile isn’t benign.\-- Sam Fazeli, BI pharmaceuticals analystRead the reportAducanumab’s path is a reflection of the rollercoaster ride that researchers and drugmakers have been on for decades in trying to develop a way to combat Alzheimer’s disease, the most common form of dementia in adults. They have tried and failed with more than 200 medications, at a cost of billions in research dollars.“This is a pivotal time in the field, certainly with regard to the development of Alzheimer’s therapeutics,” said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota, who led the discussion of the study on behalf of the scientific organizers.“Certainly there have been a lot of ups and downs in recent months and years, unfortunately more downs than ups,” said Petersen. “In many senses the aducanumab data that we are discussing today sort of characterizes -- is almost a caricature -- of the course we have had in the field.”The move comes as researchers debate whether another study will be needed to confirm the drug’s benefits before it becomes widely available, a decision that will ultimately be the domain of the U.S. Food and Drug Administration and other regulators.Shocking MoveBiogen and Eisai shocked researchers in March when they opted to shelve aducanumab, saying that trial results had suggested the drug was unlikely to work. The move caused investors to flee and disappointed scientists and patients who’ve hoped for decades to find a treatment for the harrowing incurable disease.Then, in October, the companies reversed themselves, saying new data had come to light suggesting that aducanumab could be effective. The presentation on Thursday was the first detailed look at the data behind the dramatic decision to try to salvage the therapy.As details of the trial unfurled, the most important audience was regulators who eventually will have to decide whether to allow aducanumab on the market. While the need for a medicine to slow the currently inexorable disease is enormous, the evidence of benefit will have to hold up.“People are hoping of course, always hoping, that we will find something, but we aren’t going to approve drugs that aren’t effective,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, speaking generally in an interview on Wednesday, ahead of the data release. “People won’t send us applications if their trials fail; they will just terminate their programs. Obviously there is a tremendous need in Alzheimer’s, and we’ll just have to see about data.”Biogen and Eisai plan to file for FDA approval in early 2020. Woodcock, in an interview about the agency’s recent blistering pace for drug approvals, declined to comment specifically on Biogen’s program.(Updates with Eisai trading in first paragraph.)To contact the reporters on this story: Michelle Fay Cortez in Minneapolis at email@example.com;Robert Langreth in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Drew Armstrong at email@example.com, Timothy Annett, Mark SchoifetFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Companies with gene therapy capabilities are becoming more attractive to members of Big Pharma, who are eager to add the technology to their portfolios Continue reading...
It was a sluggish day in the stock market on Friday, as investors gear up for a non-farm payrolls report on Friday and digest a rocky start to December. Let's look at a few top stock trades. Top Stock Trades for Tomorrow No. 1: RH Inc (RH)Source: Chart courtesy of StockCharts.comMan, what a blowout quarter it was for RH (NYSE:RH), formerly known as Restoration Hardware. The quarterly figures sent shares to new all-time highs, while the stock is working on its seventh straight monthly gain.After a double-digit one-day move, it's likely a bit late to start chasing the name now, but keep an eye on it going forward.InvestorPlace - Stock Market News, Stock Advice & Trading Tips * 9 Stocks That Every 20-Year-Old Should Buy On a pullback, see if prior channel resistance (blue line) acts as support. Depending how it trades, the 20-day moving average may also represent a solid buying opportunity. This recent Warren Buffett buy is certainly a buy-the-dips candidates given how well it has moved this year. Top Stock Trades for Tomorrow No. 2: Dollar General (DG)Source: Chart courtesy of StockCharts.comDollar General (NYSE:DG) is working on slight gains after reporting earnings on Thursday. For now, the stock is giving investors a very measured level of risk.Simply put, DG is holding up at its prior gap-up level, the 100-day moving average and the backside of prior downtrend resistance (blue line). A break below this area -- call it $150 -- and DG could go on to fill its gap in the lower-$140s, technically speaking.If this area holds as support, look for a rebound up to the 50-day moving average. Above that and resistance near $162.50 may be on the table. Above that and the 52-week high of $166.98 is possible. Top Stock Trades for Tomorrow No. 3: Kroger (KR)Source: Chart courtesy of StockCharts.comUnlike DG, Kroger (NYSE:KR) is struggling after reporting its quarterly results. However, not all hope is lost with Thursday's decline.If Kroger stock can hold up over $26.50 -- essentially, the September high and recent support -- then reclaiming the 20-day moving average is possible. Should it rebound further, see if KR can hurdle $28 and break out to the upside.If Kroger can't hold $26.50, then we need to consider some downside targets. First is the 50-day moving average and uptrend support (blue line). If it goes below that, $25.50 is possible. Top Stock Trades for Tomorrow No. 4: Biogen (BIIB)Source: Chart courtesy of StockCharts.comMan, Biogen (NASDAQ:BIIB) has been a wild mover since October. But guess what? The stock has been in an amazing trading range -- one that saw its highs and lows tested on Thursday.One could certainly make the case that this is a "go with" trade on a break of either range support or resistance. That is, buying the breakout over resistance or selling the break below support.For traders that do take the trade though, be vigilant. This one is a wild mover with plenty of volatility. Top Stock Trades for Tomorrow No. 5: Signet Jewelers (SIG)Source: Chart courtesy of StockCharts.comSignet Jewelers (NYSE:SIG) ripped higher by more than 6% on Thursday, but resistance kept it in check.That came from both the $18 level and the declining 200-day moving average. Fortunately though, the setup is now pretty straightforward.A move over the 200-day triggers a long entry. The first upside target is Thursday's high. Above that and $21 is possible. Below $18, and support between $16 and $17 may be called upon. There it has the 20-day and 50-day moving averages, as well as uptrend support.Dip-buyers may feel comfortable nibbling on a decline into this area, but below uptrend support could send SIG stock to $15 or lower.Bret Kenwell is the manager and author of Future Blue Chips and is on Twitter @BretKenwell. As of this writing, Bret Kenwell did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Retail Stocks to Buy That Dominated Thanksgiving Shopping * 6 Manufacturing Stocks to Buy as the Economy Recovers * The 7 Best Cryptocurrencies to Buy as Blockchain Heats Up The post 5 Top Stock Trades for Friday: RH, DG, KR, BIIB appeared first on InvestorPlace.
Biogen stock popped Thursday after the biotech company presented somewhat mixed results for its Alzheimer's treatment. In a subset of patients, the high dose showed a benefit.
Biogen doesn’t seem to have answered all the questions around its Alzheimer’s disease drug aducanumab, at a scientific conference presentation on Thursday, but it was enough for investors.
(Bloomberg) -- Thursday marked another wild day for biotechnology firms as a highly-anticipated presentation from Biogen Inc. took the spotlight and results from neurology-focused peers triggered huge stock swings amid a flurry of reports.When the dust settled in afternoon trading, the presentation from Biogen, combined with key study data from Sage Therapeutics Inc. and Acadia Pharmaceuticals Inc., resulted in a combined $7.6 billion shift in value for the three companies. The huge moves were yet another reminder of how biotechnology investing -- and, more specifically, betting on drug development for diseases affecting the brain -- can often resemble a roulette wheel.Biogen’s standing-room-only presentation of detailed results for its Alzheimer’s disease drug at a California medical meeting initially sank its shares by 5%. The stock later rallied to add about $2 billion to the company’s market value. Despite Biogen’s advance, some analysts on Wall Street were skeptical, including Mizuho’s Salim Syed, who called the data “not that impressive” and added that “old questions remain, new ones raised.”For Sage, Thursday’s trading action was a day to forget. The Cambridge, Massachusetts-based company saw its shares plummet about 60%. That was worth a whopping $4.6 billion as some investors quickly pointed out that sales of the company’s lone drug on the market are projected to top out at less than $500 million annually, Bloomberg data show.Acadia, a company focused on developing drugs to address unmet medical needs in central nervous system disorders, was among the day’s big winners after data drew praise across Wall Street. The company added a cool $1 billion to its value after presenting better than anticipated data at a conference Wednesday night for patients with dementia.Small-cap drug developer Aurinia Pharmaceuticals Inc., while not focused on neurological diseases, briefly doubled Thursday after promising data.To contact the reporter on this story: Bailey Lipschultz in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Catherine Larkin at email@example.com, Scott SchnipperFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Shares of Biogen rose 4.5% in afternoon trading in response to new data that indicates its recently resurrected experimental Alzheimer’s disease treatment can reduce cognitive decline.
Biogen 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 with the FDA. The analysis was based on a larger dataset from two Phase 3 studies dubbed EMERGE and ENGAGE, which the company had discontinued in March following failed futility analysis.
(Bloomberg Opinion) -- No drug for Alzheimer’s disease does anything but treat symptoms of the degenerative ailment. The first medicine that can do more will be an enormous breakthrough. Biogen Inc. thinks it has that drug in aducanumab. It’s a treatment the company previously announced was a failure in March, but in a highly unusual move, it is trying to resurrect the medicine and gambling that it can win Food and Drug Administration approval. The company presented an expanded case for the medication at a medical meeting on Thursday.The argument over whether the drug works and is approvable may be the sector’s biggest battleground. Biotech investing is full of so-called binary events — data releases or regulatory decisions that make or break a stock. Most come for startups. Biogen employs 7,800 people, and its market cap has swung by more than $10 billion twice on aducanumab updates. Unfortunately for bulls, Thursday’s presentation did little to suggest that the drug has much of a chance.The evidence that Biogen’s medicine works is more confusing than convincing. The company halted two identically designed trials earlier this year after a preplanned analysis found that aducanumab was unlikely to succeed. After looking at new data that came in after the cutoff point for that first analysis, however, Biogen found that aducanumab had a statistically significant impact on cognitive decline in one trial. Even though the second test was still a messy failure, the company decided to push for approval anyway. This reversal adds all sorts of statistical muddiness to even the positive trial.If regulators are somehow convinced to ignore those issues, the drug’s impact looks small even in Biogen’s favored set of patients. Add in the failed trial, and the benefit is even more uncertain. The FDA might be more comfortable with that ambiguity if the drug had no side effects. That’s not the case for aducanumab, which can cause brain swelling and microhemorrhages. The burden of proof should be especially high because every other medicine testing the same mechanism for treating Alzheimer’s has failed. The company further developed its arguments for FDA leniency on Thursday with a significant focus on a theory that a mid-study dosing change and a staggered start time explains the divergence in the two studies. Fancy charts and post-hoc data slicing can’t change the fact that this is a messy trial with inconsistent results. At best, Biogen made a case for running a new clean trial to test its dosing hypothesis, not for putting this drug on the market. An approval of aducanumab would have a bigger impact than most FDA decisions. It could lead to the spending of billions of dollars in a rapid and widespread uptake of a drug that might not work and could even harm patients. It would also make mincemeat of the FDA’s approval standards and encourage more companies to press forward with questionable data.Some investors, including those that sent Biogen’s stock up about 4.5% in the aftermath of the presentation, will continue to hope. The FDA is indeed increasingly flexible when patients don’t have options, and there may be no more significant unmet need than Alzheimer’s. The agency also isn’t immune to political and patient pressure, which will be immense in this case. Biogen’s Chief Scientific Officer Al Sandrock hinted at hard-sell tactics to come, suggesting at a recent conference that the FDA would doom more people to dementia if it required another clinical trial before approval. The upside from approval would be enormous; the world needs a treatment for Alzheimer’s disease and pent-up demand from millions of patients would most likely generate huge sales. The downside is just as significant, however. If the drug fails, investors will flee a company with flat-lining growth, a weak pipeline and a tarnished management team. Statistics and high standards are likely to win out in the end. Neither are on Biogen’s side.To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Daniel Niemi at email@example.comThis column does not necessarily reflect the opinion of the editorial board or 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/opinion©2019 Bloomberg L.P.
STOCKSTOWATCHTODAY BLOG Reversal. The three major U.S. stock mark indexes slipped into negative territory after beginning the day in the green amid continued optimism about trade. Near midday, the Dow Jones Industrial Average was down 33 points, or 0.
Shares of Biogen are up 3% after it released additional data about its recently resurrected Alzheimer's disease drug candidate. A fresh take on data from two Phase 3 trials for aducanumab showed that patients in the Emerge trial who received a high dose of the therapy reported reduced clinical decline, meeting the trial's first and secondary endpoints. The Engage trial did not report a reduction in clinical decline. The biotechnology company had said in March that it would scrap trials for aducanumab after a futility analysis indicated that the drug would not meet the studies' primary endpoints. The stock sunk to its lowest point, $216.71, in 2019 the day after that announcement. But then in a surprise move, Biogen said in October it would seek Food and Drug Administration approval for aducanumab early next year following discussions with the regulator using a larger dataset than what was used in the futility analysis. Biogen shares have fallen about 3% year-to-date, compared to the S&P 500 , which is up about 24%.
Novartis research head Jay Bradner said on Thursday the Swiss drugmaker is focusing efforts against spinal muscular atrophy (SMA) on gene therapy Zolgensma and retreating from oral therapy like its molecule LMI070, also called branaplam. Bradner's comment to an investor conference in London comes as cross-town rival Roche has won the U.S. Food and Drug Administration's accelerated priority review for its oral SMA therapy that could result in a decision by May 2020. Analysts as well as Roche have pegged risdiplam as a potential blockbuster with more than $1 billion in annual sales, as it competes with Biogen's Spinraza and Zolgensma, the $2.1 million-per-patient gene therapy for which Novartis won approval last May.
Aurinia's (AUPH) lupus candidate, voclosporin, met primary endpoint of renal response rate in a late-stage study. An NDA is expected in the first half of 2020.
Biogen is rising Thursday after the biotech presented new data on its experimental Alzheimer's drug aducanumab that did not reveal any new safety concerns.