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Stock Market & Financial Investment News

News For ACT;TEVA;ENDP;COV;ABT From The Last 14 Days
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October 8, 2014
08:05 EDTTEVATeva initiates NDA submission to FDA for CEP-33237
Teva Pharmaceutical announced the initiation of a rolling New Drug Application submission to the U.S. Food and Drug Administration for hydrocodone bitartrate extended-release tablets designed with Teva’s proprietary technology providing potential abuse-deterrent properties CEP-33237 as allowed for fast track designated products. Teva expects to complete the NDA submission by the end of 2014. Teva also announced positive results from a nasal Human Abuse Liability study which supports the NDA. The nasal HAL study found that in nondependent, recreational opioid users, abuse potential for crushed intranasal CEP-33237 was significantly lower than intranasal immediate-release hydrocodone. Teva has now completed positive HAL studies in the two most common routes of hydrocodone abuse, oral and intranasal. CEP-33237 demonstrated a safety profile in the Phase III study that is consistent with the known safety profile of hydrocodone and other opioid analgesic therapies. Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence and dizziness.
06:47 EDTACT, TEVALawmakers may push for new regulations on generic drug makers, NY Times says
After the prices of some generic drugs soared more than 1,000% over the last year, two influential members of Congress are probing the sector and threatening to look to impose new regulations on it, according to The New York Times. Generic drug makers include Teva (TEVA), Mylan (MYL), Actavis (ACT), and Lannett (LCI).Reference Link
06:23 EDTACTActavis more inclined to pursue Allergan over Salix, says Citigroup
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October 7, 2014
15:21 EDTACTAllergan warms to sale as Actavis plans new approach, Reuters says
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15:01 EDTACTAllergan up 1.5% following report on Actavis planned approach on merger
14:59 EDTACTActavis plans new approach to Allergan, Reuters reports
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10:43 EDTCOVOptions with decreasing implied volatility
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07:48 EDTACTSalix reinstated with a Buy at Jefferies
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October 6, 2014
16:20 EDTACTOn The Fly: Closing Wrap
Stocks on Wall Street opened in positive territory and appeared ready to ride the wave of optimism from Friday’s jobs report into the new week. However, with little on the economic calendar to sustain the momentum, each of the major equity indexes had given up their gains by noon. The Dow and S&P 500 made it back to flat late in the session, but weakened into the close to end the day slightly lower. The tech-heavy Nasdaq was the laggard throughout and ended the day with the most significant decline. ECONOMIC EVENTS: In the U.S., no major economic data was reported. COMPANY NEWS: Hewlett-Packard (HPQ) climbed $1.67, or 4.74%, to $36.87 after it confirmed plans to split itself into two publicly traded companies by the end of its fiscal 2015. One company will include HP's technology infrastructure, software and services businesses, to be known as "Hewlett-Packard Enterprise," while the other will include the company's PC and printing businesses and be called "HP Inc." After the announcement, HP shares were upgraded to Outperform from Neutral at Credit Suisse, while analysts at Cantor called the split "a bold and smart move" that will give HP the financial flexibility needed to sell off one or both of the PC and printing businesses if an attractive offer emerges for either or both. MAJOR MOVERS: Among the notable gainers was Durata Therapeutics (DRTX), which surged $10.36, or 74.64%, to $24.24 after the company agreed to be acquired by larger drugmaker Actavis (ACT) for $23.00 per share in cash, or approximately $675M, and contingent value rights for additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product are achieved. Also higher was CareFusion (CFN), which jumped $10.58, or 22.92%, to $56.75 after agreeing to be acquired by Becton Dickinson (BDX) for $49 in cash and 0.0777 of a share of BD for each share of CareFusion, or about $12.2B. Becton Dickinson rose $9.14, or 7.89%, to $124.98 after its deal, while Actavis slipped $2.12, or 0.86%, to $243.95, after its own, much smaller purchase. GT Advanced Technologies (GTAT) plunged $10.22, or 92.46%, to 83c after the company announced that it and some of its units had commenced voluntary cases under chapter 11 of the bankruptcy code, which Raymond James believes implies a "fundamental, severe breakdown" of the company's relationship with Apple (AAPL). Also lower were shares of Sunesis (SNSS), which dropped $5.18, or 78.01%, to $1.46 and was downgraded at RBC Capital and Wells Fargo after a trial of a combination therapy for patients with first relapsed or refractory acute myeloid leukemia did not meet its primary endpoint. INDEXES: The Dow slid 17.78, or 0.1%, to 16,991.91, the Nasdaq fell 20.82, or 0.47%, to 4,454.80, and the S&P 500 slipped 3.08, or 0.16%, to 1,964.82.
12:41 EDTACTOn The Fly: Midday Wrap
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11:58 EDTTEVATeva simplifaction plans expected but positive, says BMO Capital
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11:15 EDTACTDurata surges after Actavis takeover
Shares of Durata Therapeutics (DRTX) are surging after the drugmaker agreed to be acquired by its larger industry peer, Actavis (ACT). WHAT'S NEW: Actavis announced it will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 per share in cash, or approximately $675M in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product Dalvance are achieved. If Dalvance is approved in Europe for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI, holders of the CVR will receive $1.00 per share. If Dalvance is approved for single dose administration by the FDA, holders of the CVR will receive $1.00 per share. If a net global Dalvance revenue threshold is met over a designated time period, holders of the CVR will receive $3.00 per share. Actavis expects the acquisition to be accretive by the end of the first year, it stated. WHAT'S NOTABLE: The acquisition comes after Durata Therapeutics was granted a Special Protocol Agreement by the FDA for its Phase 3 study of Dalvance on October 3. The study was designed to study Dalvance for the treatment of patients with community-acquired pneumonia and pediatric osteomyelitis. ANALYST REACTION: BMO Capital views the acquisition as a "good deal" for Actavis that is in line with CEO Brent Saunders' goal of making investments that complement its existing business. BMO believes the acquisition does not extend Actavis' balance sheet too far, and therefore does not prevent the company from doing additional deals. The firm expects there could be more deal-related news ahead for Actavis. The Fly notes Bloomberg reported on October 2 that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis after failing to reach a deal with Allergan (AGN). PRICE ACTION: During morning trading, Durata Therapeutics gained $9.93, or 71.5%, to $23.81, Actavis slipped $1.95, or 0.8% to $244.12, and Salix fell $4.02, or 2.6%, to $148.85.
11:00 EDTCOVOptions with decreasing implied volatilit
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09:49 EDTACTActavis purchase of Durata leaves room for future deals, says BMO Capital
BMO Capital views Actavis' (ACT) deal to buy Durata Therapeutics (DRTX) as in line with its strategy of making investments that complement its existing business and as small enough that it does not prevent the company from doing additional deals. BMO expects there could be more deal-related news ahead for Actavis and keeps its Outperform rating on the stock. The Fly notes that that Bloomberg reported last week that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis.
08:32 EDTTEVATeva identifies 14 pipeline projects for discontinuation or divestment
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08:32 EDTTEVATeva announces results of strategic review of core specialty therapeutic areas
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08:07 EDTACTSalix slips in pre-market trade after Actavis strikes deal for Durata
Note that Bloomberg reported on October 2, citing people with knowledge of the matter, that Salix Pharmaceuticals (SLXP) was discussing selling itself to Actavis (ACT) after failing to reach a deal with Allergan (AGN). Actavis announced this morning that it has reached a deal to acquire Durata Therapeutics (DRTX) for $675M, or $23.00 per share. In pre-market trading, shares of Salix are down nearly 2% to $150 per share.
08:05 EDTACTActavis to acquire Durata Therapeutics for $23.00 per share or $675M
Actavis (ACT) and Durata Therapeutics (DRTX) announced that they have entered into a definitive merger agreement under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 per share in cash, or approximately $675M in the aggregate, and contingent value rights entitling the holder to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product DALVANCETM are achieved. Actavis expects the acquisition to be accretive by the end of the first year. DALVANCETM was approved by the FDA on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product. A Marketing Authorization Application for dalbavancin is under review with the European Medicines Agency, with a decision anticipated in the first half of 2015. A single-dose regimen of DALVANCETM is also in late-stage development for ABSSSI, with a supplemental New Drug Application filing expected by mid-2015. Durata also has plans to continue the development of DALVANCETM for additional indications, such as hospitalized community-acquired pneumonia and pediatric osteomyelitis. Under the terms of the definitive merger agreement, it is anticipated that Actavis will promptly commence the cash tender offer to purchase all of the outstanding shares of Durata common stock for $23.00 per share in cash, plus CVRs of up to an additional $5.00 per share in the event certain developmental or commercial milestones are met. If DALVANCETM is approved in Europe for ABSSSI, holders of the CVR will receive $1.00 per share. If DALVANCETM is approved for single dose administration by the FDA, holders of the CVR will receive $1.00 per share. If a net global DALVANCETM revenue threshold is met over a designated time period, holders of the CVR will receive $3.00 per share.
08:04 EDTACTActavis to acquire Durata Therapeutics for $23.00 per share or $675M
07:12 EDTCOVThe MedTech Conference holds a conference
AdvaMed 2014 is being held in Chicago on October 6-8.
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