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News Breaks
February 14, 2013
09:11 EDTSHPG, TEVATeva's generic version of Shire's Adderall XR approved by FDA
Teva (TEVA) announced that the FDA has approved its Abbreviated New Drug Application for the generic version of Shire (SHPG)ís Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR had annual sales, including brand and generic sales, of approximately $2B in the United States.
News For TEVA;SHPG From The Last 14 Days
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February 11, 2016
07:03 EDTTEVATeva sees Q1 adjusted EPS $1.32-$1.36, consensus $1.21
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07:01 EDTTEVATeva reports Q4 adjusted EPS $1.32, consensus $1.29
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05:44 EDTTEVAOptions expected to be active
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February 10, 2016
17:28 EDTSHPGShire partner Shionogi submits NDA in Japan for ADHD treatment for children
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14:32 EDTTEVANotable companies reporting before tomorrow's open
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10:02 EDTSHPGOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Aralez (ARLZ) initiated with a Buy at Guggenheim... Atlassian (TEAM) initiated with a Neutral at Baird... CareDx (CDNA) initiated with a Buy at Janney Capital... Denison Mines (DNN) initiated with a Buy at Roth Capital... Deutsche Boerse (DBOEY) initiated with a Neutral at Exane BNP Paribas... Instructure (INST) initiated with an Outperform at Oppenheimer... Kirkland's (KIRK) initiated with a Buy at B. Riley... Mesa Labs (MLAB) initiated with a Buy at Janney Capital... Natural Grocers (NGVC) initiated with a Hold at Deutsche Bank... Nordex (NRDXF) initiated with an Overweight at Barclays... Old Line Bancshares (OLBK) initiated with a Market Perform at Keefe Bruyette... Shire (SHPG) initiated with a Neutral at Guggenheim... T2 Biosystems (TTOO) initiated with a Buy at Cantor... iRobot (IRBT) initiated with a Buy at Chardan.
09:19 EDTSHPGOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Akamai (AKAM), up 16.5%... Prospect Capital (PSEC), up 10.7%... Panera Bread (PNRA), up 2%. ALSO HIGHER: Deutsche Bank (DB), up 6.1% after the Financial Times reported that the company is considering a multibillion bond buyback... Fitbit (FIT), up 3.7% after Marc Benioff reported a 5% stake in the company... FireEye (FEYE), up 3.9% after being upgraded to Buy from Neutral at BTIG... Shire (SHPG), up 1.7% after being upgraded to Outperform from Sector Perform at RBC Capital. DOWN AFTER EARNINGS: Time Warner (TWX), down 7.6%... Disney (DIS), down 5.1%... SolarCity (SCTY), down 27.8%. ALSO LOWER: CTI BioPharma (CTIC), down 38% after the FDA placed pacritinib IND on full clinical hold... Mast Therapeutics (MSTX), down 40.1% after 29.1M share Spot Unit offering priced at $0.275.
09:01 EDTTEVATeva volatility elevated into Q4 and outlook
Teva February weekly call option implied volatility is at 81, February is at 51, March is at 37; compared to its 52-week range of 20 to 41, suggesting large near term price movement into the expected release of Q4 results on February 11.
08:25 EDTSHPGShire upgraded on valuation at RBC Capital
As noted earlier, RBC Capital upgraded Shire to Outperform from Sector Perform. The firm believes that the recent decline in the stock more than accounts for any competitive risks facing the company's Baxalta drug. Target $240.
07:19 EDTSHPGShire says David Kappler to step down as deputy chairman
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06:28 EDTSHPGShire upgraded to Outperform from Sector Perform at RBC Capital
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February 9, 2016
16:14 EDTSHPGShire initiated with a Neutral at Guggenheim
09:56 EDTSHPGIntercept higher following report of vague takeover chatter
Shares of Intercept Pharmaceuticals (ICPT) are moving after United Kingdom blog Proactive Investors discussed "reheated rumours" of a takeover. "Vague talk" has Intercept teaming up with CenterView Partners to advise on a sale, the blog states. It mentions AstraZeneca (AZN) as a possible suitor now that Shire (SHPG) has reached an agreement to acquire Baxalta (BXLT). Shares of Intercept, which is developing treatments for chronic liver diseases, are up 4% to $97.39 in early trading.
February 8, 2016
09:34 EDTTEVAPfizer sees decision about potential separation by no later than end 2018
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February 4, 2016
16:00 EDTSHPGShire's NDA for lifitegrast for dry eye resubmssion acknowledged by FDA
Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22.
February 3, 2016
08:07 EDTSHPGMedgenics names Brian Piper to succeed John Leaman as CFO
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February 2, 2016
09:46 EDTSHPGIntercept rumored to draw interest from many suitors, Daily Mail says
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08:12 EDTTEVATeva enters into collaborative research agreement with AbCellera
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08:01 EDTTEVATeva, AbCellera enter agreement to discover rare monoclonal antibodies
Teva and AbCellera have entered into a collaborative research agreement whereby AbCellera will apply its high-throughput single cell antibody platform for the discovery of rare monoclonal antibodies. Under the terms of the agreement, AbCellera will receive an upfront payment, research payments, and is eligible to receive undisclosed downstream milestones associated with the development and approval of therapeutic antibodies.
February 1, 2016
08:04 EDTTEVATeva Mylan not seeing same negative trends as Sandoz, says Bernstein
After Novartis (NVS) reported weak results for its generics unit, Sandoz, and blamed it on industry trends, Bernstein quotes Mylan (MYL) and Teva (TEVA) as saying that they are seeing only "slight adjustments back to normal levels" from "mildly favorable" results in 2014 and 2015. Bernstein says that Sandoz has lost a number of fairly profitable products and has had fewer approvals than its peers. Bernstein keeps Outperform ratings on Teva and Mylan.
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