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News For ELN;BIIB From The Last 14 Days
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September 29, 2015
12:33 EDTBIIBOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday as the market seeks to break its losing streak, helped by an improvement in consumer confidence that came despite the recent market volatility. ECONOMIC EVENTS: In the U.S., consumer confidence unexpectedly rose in September. Analysts expected the consumer confidence reading to pull back to 96.8 from the prior 101.5 figure, but it actually strengthened to 103.0. The S&P/Case-Shiller 20-city composite home price index was up a seasonally adjusted 0.2% month over month in July, versus the consensus forecast for a rise of 0.1%. Stocks sold off in much of Asia last night, with China's Shanghai composite index sliding 2% while Japan's Nikkei dropped 4%, erasing year-to-date gains in the process. COMPANY NEWS: Shares of Yahoo (YHOO) advanced 3% after its board authorized the company to continue to pursue its spin-off of Aabaco Holdings, a newly formed independent registered investment company that will hold all of Yahoo's remaining holdings in Alibaba Group (BABA). MAJOR MOVERS: Among the notable gainers was Radius Health (RDUS), which rose nearly 10% after Ben Harrington of the Betaville blog stated during an appearance on Tip TV that he has heard that "something will be happening" in terms of M&A involving the company over the "next few weeks." Also higher were several recently beaten down biotech stocks that were seeing some bounceback, including Vertex Pharmaceuticals (VRTX), which gained 5%, and Biogen (BIIB), which advanced 4%. Notably, both of them, along with Amgen (AMGN), were mentioned in a note to investors by Cowen analyst Ken Cacciatore as "hypothetical" targets for Allergan (AGN). Among the noteworthy losers was OvaScience (OVAS), which dropped 38% after saying it now longer expects to meet its 2015 goal of 1,000 Augment cycles. Esperion (ESPR) also fell 38% after the company warned that the FDA could require it to undertake new studies before its ETC-1002 is approved. INDEXES: Near midday, the Dow was up 7.27, or 0.05%, to 16,009.16, the Nasdaq was up 7.38, or 0.16%, to 4,551.35, and the S&P 500 was up 4.56, or 0.24%, to 1,886.33.
08:57 EDTBIIBCowen lists Vertex, Biogen and Amgen as hypothetical Allergan targets
Cowen analyst Ken Cacciatore noted that the price agreed for Allergan's (AGN) generic divestiture to Teva (TEVA) is fixed and that the cash value from this deal has not depreciated in any way while the corresponding valuations of potential targets have corrected, increasing the potential value creation available for Allergan as it decides how to deploy its capital. To illustrate the value creation that Allergan's capital deployment could generate, Cacciatore estimates the type of accretion potential that might be seen if the company were to buy Vertex with an acquisition price of $36.5B, if it were to acquire Biogen (BIIB) at a price of $91B or if it were to purchase Amgen (AMGN) with an acquisition price of $140B. Although the market correction has lowered Allergan's stock, the decline could be viewed as a near-term positive, given that a key component of its strategy and business model is to seek to aggressively deploy its capital, Cacciatore argues in a note to investors. The analyst keeps an Outperform rating and $400 price target on Allergan shares.
06:06 EDTBIIBBiogen volatility at 52-week highs
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September 28, 2015
05:35 EDTBIIBBiogen implied volatility of 52 at upper end of index mean range
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September 25, 2015
12:38 EDTBIIBOptions with increasing implied volatility
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07:55 EDTBIIBBiogen, Sobi receive position opinion for Elocta from CHMP
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07:32 EDTBIIBBiogen, Sobi receive positive CHMP opinion for Elocta for Hemophilia A
Biogen and Swedish Orphan Biovitrum AB received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the marketing authorization of ELOCTA. ELOCTA is a recombinant factor VIII Fc fusion protein product for the treatment of hemophilia A that, if approved, would be the first hemophilia A treatment with prolonged circulation available in the European Union. The positive opinion was based on results from the pivotal, Phase 3 A-LONG clinical study, which examined the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe hemophilia A, and from the Phase 3 Kids A-LONG clinical study, which evaluated the efficacy and safety of rFVIIIFc in previously treated male children with hemophilia A under 12 years of age. The Committee's positive opinion is now referred to the EC, which grants marketing authorization for medicines in the EU. ELOCTA is the European trade name for rFVIIIFc, which is also known as ELOCTATE in the U.S., Canada, Australia, New Zealand and Japan, where it is approved for the treatment of hemophilia A. Commonly reported adverse drug reactions in the clinical studies were arthralgia, malaise, myalgia, headache and rash. Development of Factor VIII neutralizing antibodies may occur following administration of ELOCTA. Biogen and Sobi are collaboration partners in the development and commercialization of ELOCTA/ELOCTATE for hemophilia A. Last year, Sobi exercised its opt-in right to assume final development and commercialization of ELOCTA in the Sobi territories. Biogen leads development for ELOCTA/ELOCTATE, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
September 23, 2015
10:24 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility: SNCR PTCT SRPT AMZN CREE CMG ISRG QLIK SNKD BIIB JNPR
09:55 EDTBIIBActive calls on open: BIIB FCX X F INTC
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09:33 EDTBIIBActive equity options trading on open: AAPL BBRY BIDU BIIB
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September 22, 2015
20:02 EDTBIIBClinton vows $250 cap on monthly drug costs in blast against biotechs, insurers
Democratic presidential candidate Hillary Clinton railed against biotech companies as well as health insurers at a community health care forum in Iowa on Tuesday. Clinton began her speech by praising the Affordable Care Act, but quickly noted that she wants to strengthen it due to what she called the rising cost of prescription drugs. She explained, "Our pharmaceutical and biotechnology industries deserve credit... [But] too often, these drugs cost a fortune. Now, sometimes there is a good reason for that. Scientific breakthroughs are often the result of major investment... so it may makes sense, for a short period of time, to have to charge a lot of money for a drug. But when a drug has no competition, when there aren't any other treatments that can do what it does, pharmaceutical companies can charge astronomical fees far beyond anything that it would take to recoup their investment, and far beyond what they charge consumers anywhere else in the world outside of America." Referencing the recent criticism against Turing Pharmaceuticals, Clinton went on to say that "pharmaceutical companies that acquire an existing affordable drug that people rely on, and then turn around and charge a fortune for it, [are just betting] on the fact that desperate people will find some way to pay for it." Preemptively responding to questions of whether greater regulation will dampen investment, Clinton commented that "some people worry that my proposals will threaten innovation, but I have designed a plan that will do exactly the opposite... Under my plan, drug companies that want to keep getting federal support will have to redirect more of their profits into meaningful investments in research and development." Clinton also criticized incremental drug improvements, saying that "too often, so-called new drugs are really old drugs that have just been tweaked a little bit, but then they're marketed as breakthrough drugs and they're sold for high prices." The Democratic candidate went on to condemn advertising in the drug industry, remarking that "I also want to tackle direct to consumer advertising... Other countries ban these ads because they are so often misleading. But at the very least, we shouldn't be encouraging them with corporate write-offs... Under my plan, we will instead use that taxpayer money to fund innovation... I would also like to make sure any ads the drug industry does run are approved by the FDA." Moving more broadly onto Medicaid and health insurers, Clinton stated, "I believe Medicare should be able to negotiate for lower prices for its members... I will require drug companies to provide higher rebates for prescription drugs to low income Medicare patients, just like they have to do for Medicaid patients... I think the insurance companies need to be put on notice." Providing more concrete details of her plan, Clinton concluded, "I will cap out of pocket drug costs for working families. You won't have to pay more than $250 a month for covered medications... Particularly for people who have a chronic illness. Also under my plan, you will be able to import cheaper drugs from other countries legally. If the medicine you need costs less in Canada, you should be able to buy it from Canada or any other country that meets our safety standards... I will also make sure we have more generics on the market [by boosting funding for] the FDA's office of generic drugs."
17:35 EDTBIIBHillary Clinton vows to cap out-of-pocket drug costs at $250 per month
Presidential candidate Hillary Clinton said in a tweet that, "Under my plan, I'll cap out-of-pocket drug costs for families. You won't have to pay more than $250/month for covered medications." Reference Link
08:23 EDTBIIBAnalysts say buy select biotech stocks ahead of Clinton drug plan
Ahead of Presidential candidate Hillary Clinton laying out her plan to tackle "price gouging" in the specialty drug market at an event in Iowa later today, analysts at research firms Jefferies and Piper Jaffray are recommending select biotech stocks that they view as buys amid the weakness in the space. DEBATE: Biotech stocks broadly declined yesterday, with the NASDAQ Biotechnology index (IBB) sliding roughly 4.4%, after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on a 62-year-old drug that fights complication of AIDS and cancer. Furor around the sudden price hike for Turing's Daraprim reignited a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. The news also follows Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Pfizer's (PFE) Hospira, in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. Presidential candidate Hillary Clinton sent the debate to center stage yesterday by criticizing the "outrageous" prices of specialty drugs and promising to lay out a plan today to tackle "price gouging" in the specialty drug market. Clinton's proposal, which she'll outline in a speech in Iowa later today, would force pharmaceutical companies to reinvest their profits into research, allow for more generic and imported drugs and allow Medicare to negotiate lower drug costs and cap out-of-pocket expenses, according to details of the plan shared with USA Today. Zeke Emanuel, chair of medical ethics and health policy at the University of Pennsylvania, appeared on Nightly Business Report to discuss the problem of high drug prices and his suggested solutions. During his interview, Emanuel contended that giving Medicare the ability to negotiate drug prices may drive up prices for everyone else. DEFENSES: The Jefferies Biotechnology research team, led by Brian Abrahams, Eun Yang and Biren Amin, say their Washington D.C. consultants indicate the recent political rhetoric around drug pricing is unlikely to result in any substantive future policy changes that would impact biotech sector fundamentals. As such, they recommend using yesterday's selloff to buy select companies including Celgene (CELG), BioMarin (BMRN) and Alkermes (ALKS). Pricing concerns are nothing new, and will likely continue to be a headwind for the sector, the analysts tell investors in a research note. Hillary Clinton's proposal to combat drug pricing is likely to include "some combination of old and tried policies that have been out there for a few years," they write. The analysts also like shares of AMAG Pharmaceuticals (AMAG), Alder Biopharmaceuticals (ALDR) and Cempra (CEMP). Meanwhile, Piper Jaffray analyst Edward Tenthoff recommends buying shares of Vertex Pharmaceuticals (VRTX) following yesterday's selloff. Tenthoff believes that drugs like Vertex's Orkambi will maintain premium pricing because of the disease modifying value to patients and payors. Orkambi is approved to treat cystic fibrosis in patients 12 years and older. The analyst reiterates an Overweight rating on Vertex with a $163 price target. DOWNGRADE: Brean Capital analyst Difei Yang downgraded Horizon Pharma (HZNP) to Hold saying "unsettling recent developments" make the stock's premium valuation no longer justified. The public discussion on high drug prices is a negative for the company while its attempt to acquire Depomed (DEPO) is unlikely to result in a completed deal, Yang tells investors in a research note. Further, Horizon's prescription trends are showing weakness, said Yang, who views the stock as more risky than in the past. PRICE ACTION: Horizon closed yesterday down $2.93, or 9.2%, at $28.99, while Vertex dropped $5.97, or 4.8%, to $118.19. A number of the biggest stocks in biotechnology were also weak yesterday, with Gilead sliding about 2.5%, Amgen (AMGN) dropping 2.3%, Celgene declining 2.8% and Biogen (BIIB) falling more than 5.5%.
07:43 EDTBIIBDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTBIIBClinton to roll out plan to rein in prescription drug costs, USA Today reports
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05:09 EDTBIIBStocks with implied volatility movement; BIIB CELG
Stocks with implied volatility movement; Biogen (BIIB) 44m Celgene (CELG) 38 according to iVolatility.
September 21, 2015
14:04 EDTBIIBClinton vow to end drug price gouging sinks biotechs
Biotech stocks have declined across the board in afternoon trading following a tweet by Presidential candidate Hillary Clinton criticizing the "outrageous" prices of specialty drugs. TURING STEPS UP PRICING: Clinton's tweet directly referenced Turing Pharmaceuticals' Daraprim treatment for toxoplasmosis, which recently had its price hiked from just $13.50 per pill to $750 after the privately-held company acquired the drug from Impax Laboratories (IPXL). Importantly, Daraprim was first approved by the FDA in 1953 and its patents have long since expired. No generic versions of the drug currently exist, perhaps in part due to Turing executive chairman Martin Shkreli's strategy of tightly controlling distribution, according to a New York Post article on the issue. In a Bloomberg TV interview this morning, Shkreli claimed that the drug remains underpriced compared to what he called its peers in the rare disease space. However, note that a World Health Organization analysis from 2013 reported that over 190,000 cases of toxoplasmosis occur globally every year and Daraprim continues to be listed on the organization's list of essential medicines for a basic health-care system. INDUSTRY CRITICISM: Turing's Daraprim pricing prompted a response from the Infectious Diseases Society of America and the HIV Medicine Association, which criticized the "unjustifiable" new cost of the drug and urged a "rational" pricing strategy. The news surrounding Daraprim also comes on the heels of Presidential candidate Bernie Sanders issuing a letter in August to Valeant (VRX) and Hospira (HSP), in which he requested information on the "enormous" price increases of two drugs Valeant acquired earlier in the year. REPUBLICAN CONGRESS: In a research note released this afternoon, RBC Capital analyst Michael Yee reminded investors that Republicans still control Congress, offering a sobering reminder that campaign trail promises often fall by the wayside once the candidate steps into office. Yee explained that, though drug pricing debates during next year's election will probably generate headline risk for the biotech space, the Republican-controlled Congress is unlikely to sign into law any material changes on the issue. BIOTECH STOCK ACTION: Hillary Clinton's promise to "lay out a plan" tomorrow to tackle "price gouging" in the specialty drug market sent numerous biotech stocks plunging. Aerie Pharmaceuticals (AERI) has crashed 12.6% at time of writing, while Retrophin (RTRX), Ultragenyx (RARE), and PTC Therapeutics (PTCT) are down 14.7%, 13.4%, and 11%, respectively. Biotech giants AbbVie (ABBV), Gilead (GILD), Bristol-Myers Squibb (BMY) and Biogen (BIIB) have also slipped in intraday trading, while the NASDAQ Biotechnology index is down roughly 4%.
13:17 EDTBIIBBiogen volatility increases into Clinton prescription drug plan
Biogen current 30-day call option implied volatility is at 41, compared to a one-month ago level of 22, suggesting large price movement into Hillary Clinton announcing her prescription drug plan on Tuesday.
13:17 EDTBIIBRBC reminds biotech investors that Republicans still control Congress
RBC Capital analyst Michael Yee notes that biotech indices are under pressure after Hillary Clinton tweeted about an upcoming plan to fight specialty drug pricing. The news follows a Wall Street Journal story about a private company dramatically increasing the price of their drug and another confirmed progressive multifocal leukoencephalopathy case for Biogen (BIIB), Yee tells investors in an intraday research note. Next year's election is likely to turn up the noise around drug pricing, creating headline risk for the biotech space, the analyst cautions. However, he reminds investors that Republicans control Congress, making it unlikely that "anything material" will get signed into law. Biotech names moving lower in today's trading include Biogen, AbbVie (ABBV), Gilead (GILD), Alkermes (ALKS), BioMarin (BMRN), Amicus (FOLD) and PTC Therapeutics (PTCT).
09:07 EDTBIIBBioMotiv, Biogen form strategic partnership
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