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December 19, 2012
16:12 EDTFOLD, GSKAmicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed.
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August 26, 2014
08:47 EDTGSKGenetic Technologies says NC court denies GlaxoSmithKline motion to dismiss
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August 25, 2014
12:19 EDTGSKOn The Fly: Midday Wrap
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11:11 EDTFOLDOptions with decreasing implied volatility
Options with decreasing implied volatility: AMPE FOLD ITMN AEO DKS WUBA URBN SPLS YOKU GME
10:40 EDTGSKBiotechs rise after InterMune acquired by Roche
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06:11 EDTFOLDStocks with implied volatility movement; FOLD GILD
Stocks with implied volatility movement; Amicus Therapeutics (FOLD) 87, Gilead (GILD) 25 according to iVolatility.
August 22, 2014
14:19 EDTGSKViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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10:06 EDTFOLDOptions with decreasing implied volatility
Options with decreasing implied volatility: AMPE FOLD GME YOKU SPLS DKS WUBA ARWR ACHN
August 21, 2014
10:22 EDTFOLDOptions with decreasing implied volatility
Options with decreasing implied volatility: AMPE FOLD VHC ACHN JCP WB JD YPF
August 20, 2014
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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11:44 EDTGSKMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:42 EDTFOLDOptions with decreasing implied volatility
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11:09 EDTFOLDHigh option volume stocks
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10:31 EDTFOLDAmicus price target raised its price target to $14 from $9 at Cowen
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09:36 EDTFOLDActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL FOLD TSLA TWTR WHX FB TM NFLX X EOG
09:07 EDTFOLDOn The Fly: Pre-market Movers
UP AFTER EARNINGS: PetSmart (PETM), up 2,1%... Staples (SPLS), up 2%... E-House (EJ), up 2.5%. HIGHER: Fairchild (FCS), up 4% after Bloomberg says Infineon (IFNNY) is near a deal to buy a U.S. semiconductor company for $2B... Amicus Therapeutics (FOLD), up 18.4% after reporting positive Phase 3 data from the Fabry study. DOWN AFTER EARNINGS: Lowe's (LOW), down 3%... Tarena (TEDU), down 9%... Leju (LEJU), down 4.2%... JA Solar (JASO), down 5%. LOWER: Hertz (HTZ), down 12.7% after downgraded at JPMorgan and Deutsche Bank following the company's decision to withdraw its FY14 guidance... NovaBay (NBY), down 35.2% after primary, secondary endpoints were not met in its NVC-422 study... RGS Energy (RGSE), down 14.9% after downgraded at Roth Capital following Q2 earnings results.
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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06:34 EDTFOLDAmicus Therapeutics to host conference call
Conference call to discuss results of Phase 3 Fabry monotherapy study will be held on August 20 at 8 am. Webcast Link
06:08 EDTFOLDAmicus Therapeutics reports positive Phase 3 data from Fabry study
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