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June 10, 2014
08:24 EDTABBV, MRK, IDIXAbbVie shares defended at BMO Capital
After Abbvie's (ABBV) stock fell following Merck's (MRK) acquisition of Idenix (IDIX), BMO Capital still believes that the size and durability of the HCV market and Abbvie's franchise are unappreciated. The firm sees Merck as a significant competitor in HCV, but adds that the potential of the assets it acquired from Idenix is "uncertain and somewhat risky." BMO Capital continues to identify AbbVie as a top pick.
News For ABBV;IDIX;MRK From The Last 14 Days
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September 28, 2015
07:52 EDTABBV, MRKIIR Holdings to hold a conference
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07:31 EDTMRKMerck says Japan's PMDA approves Marizev DPP-4 inhibitor for Type 2 diabetes
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07:27 EDTABBVFDA and the Parental Drug Association to co-host a conference
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05:25 EDTABBVAbbVie's Viekirax receives approval in Japan
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September 27, 2015
16:47 EDTMRKMerck reports Phase 1b data on Keytruda for two gastrointestinal cancers
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14:58 EDTMRKMerck announces Phase 1b data on Keytruda for nasopharyngeal cancer
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September 25, 2015
16:35 EDTABBVStocks end week lower as biotechs sink, Volkswagen crashes
Stocks ended the week lower after concerns about drug prices were reignited, sinking biotech stocks, an emissions scandal engulfed Volkswagen (VLKAY), dragging down shares of automakers and their suppliers, and Caterpillar (CAT) announced that it may eliminate as many as 10,000 jobs in the next three years as commodity prices continue to slump. MACRO NEWS: Following the Federal Reserve's decision last week to wait before raising rates, the central bank made a concerted effort to give the market more clarity this week. Over last weekend, three Federal Reserve officials - San Francisco Fed President John Williams, St. Louis Fed President James Bullard and Richmond Fed President Jeffrey Lacker - all argued that an interest-rate increase is still warranted this year. Then, on Thursday night, Fed Chair Janet Yellen said during a speech at UMass Amherst that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago... In the U.S., Markit's flash manufacturing purchasing manager's index was flat at 53.0 in September, which was slightly better than the expectation for it to dip to 52.8. Durable goods orders for August declined 2.0%, versus expectations for a drop of 2.3%. When transportation items were removed, the core reading was breakeven, versus expectations for a rise of 0.1%. The third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... The Asian Development Bank cut its growth forecast for the region, citing a weaker outlook for China and India and a delayed recovery in the world's advanced economies. The bank now sees the Chinese economy growing 6.8% this year and 6.7% next year, down from its previous forecasts of 7.2% and 7%, respectively. Markit's flash manufacturing PMI for China fell to 47.0 in September from 47.3 last month. Meanwhile, Japanese Prime Minister Shinzo Abe unveiled new economic targets, including a goal for a 20% increase in the target size of the Japanese economy to 600T yen, though he gave no timeframe for achieving this aspiration... In Europe, Markit's composite PMI for the eurozone came in at 53.9 in the first look for September, down from 54.3 in August and below expectations for a reading of 54.1. COMPANY NEWS: Biotech stocks declined after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on its treatment for toxoplasmosis, reigniting 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. Presidential candidate Hillary Clinton sent the debate to center stage by criticizing the "outrageous" prices of specialty drugs and laying out a plan to tackle "price gouging" in the specialty drug market. The NASDAQ Biotechnology index fell roughly xxx% for the week amid the attention paid to Turing's drug and Clinton's response... Volkswagen (VLKAY) shares trading in New York fell sharply to begin the week and ended the week far from where they'd been last Friday before the EPA said it found manipulations that violate U.S. environmental standards while testing certain of the automaker's diesel cars. The EPA said Volkswagen may face civil penalties of $37,500 for each vehicle not in compliance with federal clean air rules, which could total as much as $18B, according to Reuters. In the wake of the scandal, Chief Executive Officer Martin Winterkorn resigned, with the company's supervisory board subsequently praising the decision and selecting Matthias Mueller, the former head of Porsche (POAHY), as Winterkorn's successor as the company's new CEO... Caterpillar (CAT) shares dropped after the heavy machinery maker announced plans for job cuts and lowered its revenue guidance for this year and next. Caterpillar said that it would lay off 4,000-5,000 of its employees between now and the end of 2016 and could lay off up to 10,000 employees by 2018. Caterpillar cut its fiscal year 2015 revenue forecast by $1B and said its sees its fiscal year 2016 revenue to be 5% below this year, adding that it expects revenue declines in all three large segments next year... Online and mobile deal provider Groupon (GRPN) said it plans to cut 1,100 jobs relating primarily to the company's international operations... Nike jumped after the athletic gear giant reported better than expected earnings and futures orders, prompting numerous price target hikes and at least one upgrade at Street research firms. Among other companies reporting earnings this week, BlackBerry (BBRY), ConAgra (CAG), Carnival (CCL), and CarMax (KMX) fell immediately following their quarterly reports... Apple (AAPL), which has previously been reported to be working on an electric car via its "Project Titan," is speeding up those efforts and setting 2019 as a target to ship its first vehicle, according to The Wall Street Journal... Against the backdrop of China's President Xi Jinping visiting the U.S., Boeing (BA) announced deals to sell 300 planes to three Chinese companies and set up an aircraft factory in in the Asian nation, while Cisco (CSCO) announced a partnership with Chinese server maker Inspur Group... Lloyd Blankfein, Goldman Sachs (GS) Chairman and CEO, disclosed that he was diagnosed with lymphoma. "Fortunately, my form of lymphoma is highly curable and my doctors' and my own expectation is that I will be cured," Blankfein stated in an open letter that was shared by the bank... GoPro (GPRO) finished the week about xxx% lower after Barron's contended in a feature article last weekend that the company's stock could plunge another 30% to $25 as Apple, Sony (SNE) and others pressure the company's "one-hit wonder" products... On the M&A front, Atmel (ATML) agreed to be acquired by German chipmaker Dialog Semiconductor in a deal valued at roughly $4.6B and Starwood Waypoint (SWAY) announced a stock-for-stock merger agreement with Colony American Homes. INDEXES: The Dow lost about 0.43% to close at 16,314.67, the S&P 500 fell about 1.35% to close at 1,931.34, and the Nasdaq declined about 2.89% to close at 4,686.50.
15:31 EDTMRKMerck volatility elevated as shares trend lower
Merck October weekly call option implied volatility is at 39, October is at 34, November is a 29; compared to its 52-week range of 15 to 34, suggesting large price movement after presidential candidate Hilary Clinton announced plans early this week to cap prescription drug prices.
08:15 EDTMRKMerck narrow Keytruda label may not matter as much as thought, says Bernstein
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07:22 EDTABBVEuropean Society for Medical Oncology to hold a conference
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07:16 EDTABBVAbbVie to advance onve-daily ABT-494 to Phase 3 by year-end
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07:15 EDTABBVAbbVie's ABT-494 meets primary endpoint in two Phase 2 studies
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September 24, 2015
17:04 EDTMRKMerck, Pfizer to collaborate with Agilent's Dako on Avelumab diagnostic
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16:03 EDTMRKNewLink Genetics awarded $8.1M from DTRA to advance Ebola vaccine
NewLink Genetics (NLNK) announced that the Defense Threat Reduction Agency of the Department of Defense has awarded a subsidiary of NewLink Genetics an $8.1M base contract with future options totaling $5.2M to support various development activities of the investigational rVSV-ZEBOV Ebola) vaccine candidate. NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck (MRK). In late 2014, Merck, known as MSD outside the United States and Canada, licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Clinical studies of the rVSV-ZEBOV are ongoing.
September 23, 2015
08:50 EDTMRKProvectus initiates Phase 1b/2 trial of PV-10 combo with Pembrolizumab
Provectus Biopharmaceuticals (PVCT) announced it has completed development of the protocol for Phase1b/2 testing of its investigational cancer drug PV-10 in combination with pembrolizumab in patients with Stage IV melanoma. Pembrolizumab, also known as Keytruda, a product of Merck (MRK), is an immune checkpoint inhibitor approved for treatment of patients with advanced or unresectable melanoma. PV-10 is Provectus's novel investigational drug for cancer that is injected into solid tumors. It is currently undergoing Phase 3 clinical testing in patients with Stage III melanoma. Clinical testing under the new Phase 1b/2 protocol is expected to commence before the end of the year. The FDA granted accelerated approval to pembrolizumab in September 2014, making it the first FDA-approved anti-PD-1 immune checkpoint inhibitor. Because pembrolizumab is already FDA-approved, Provectus can commence this study with or without assistance of a partner.
September 22, 2015
20:02 EDTABBVClinton 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 EDTABBVHillary 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 EDTABBVAnalysts 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 EDTMRKDrug stocks could be hurt by focus on pricing, says Oppenheimer
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06:19 EDTMRK, ABBVClinton to roll out plan to rein in prescription drug costs, USA Today reports
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