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GSK

GlaxoSmithKline

$38.93

0.83 (2.18%)

10:29
11/25/16
11/25
10:29
11/25/16
10:29

GlaxoSmithKline announces EU regulatory submission for shingles vaccine

GlaxoSmithKline announced the regulatory submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval for its candidate shingles vaccine, Shingrix, for the prevention of herpes zoster in people aged 50 years or over. The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. The phase III clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia, a form of chronic pain associated with shingles. Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses, with a two-to-six month interval between doses. The regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively. The submission to the EMA follows regulatory submissions to the U.S. FDA in October of this year and to Canada regulatory authorities earlier this month, with a Japan submission planned for 2017.

  • 29

    Nov

GSK GlaxoSmithKline
$38.93

0.83 (2.18%)

09/23/16
09/23/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Morgan Stanley analyst Brian Nowak initiated Activision Blizzard (ATVI) and Electronic Arts (EA), both with Overweight ratings. The analyst is bullish on the digital gaming shift away from "units sold" to a business model based on users, engagement, and digital monetization. He sees digital in-game offerings resulting in recurring and growth user bases, increased per-game engagement, and further monetization opportunities. 2. AstraZeneca (AZN) and GlaxoSmithKline (GSK) both initiated with Overweight ratings by Piper Jaffray analyst Richard Purkiss. 3. Achillion (ACHN) initiated with an Outperform by Wedbush analyst Heather Behanna, who set a $13 price target on the shares. 4. Sysco (SYY) initiated with an Underweight at Barclays and $48 price target by analyst Karen Short. 5. Five Below (FIVE), Dollar Tree (DLTR) and Dollar General (DG) all initiated with Equal Weight ratings by Barclays analyst Karen Short. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/03/16
RBCM
10/03/16
NO CHANGE
Target $95
RBCM
Outperform
Gilead HIV franchise could see risk from competitor data, says RBC Capital
RBC Capital analyst Michael Yee said his conversations with doctors leads him to think two dolutegravir HIV "doublet" studies being conducted by GlaxoSmithKline (GSK) and ViiV Healthcare - Glaxo's joint venture with Pfizer (PFE) and Shionogi - are likely to work and present an underappreciated risk to Gilead's (GILD) HIV franchise. Talks with investors lead Yee to believe few are even aware of this risk and that the consensus view is underestimating the probability these non-inferiority trials will work. Arguing that the consensus view should factor in more conservative assumptions for Gilead's HIV business post 2018 due to this risk, Yee cut his price target on Gilead to $95 from $105, but keeps an Outperform rating on the shares.
10/06/16
PIPR
10/06/16
NO CHANGE
Target $46
PIPR
Overweight
Piper thinks Alnylam failure is positive for Ionis
Piper Jaffay analyst Joshua Schimmer thinks Alnylam Pharmaceuticals' (ALNY) "abrupt halt" of revusiran for TTR cardiomyopathy is likely a positive for Ionis Pharmaceuticals' (IONS) transthyretin program. The move "knocks out a competitive drug" while Ionis and GlaxoSmithKline (GSK) remain on their previously indicated timeline, Schimmer tells investors in a research note. The analyst at this point believes Alnylam's setback will be limited to revusiran and not read-through to other Gal-Nac programs or other TTR cardiomyopathy or polyneuropathy programs. He keeps an Overweight rating on Ionis with a $46 price target,
11/09/16
SBSH
11/09/16
NO CHANGE
SBSH
Citi sees Healthcare 'relief rally' after Trump win
Citi analyst Andrew Baum expects a "'relief rally" to drive near-term sector outperformance for names in the Healthcare space given the "inability of the Democrats to attain the Presidency, the House or Congress." Longer term, however, the analyst still sees "significant continued legislative risk" for pharma reimbursement. Baum prefers GlaxoSmithKline (GSK), AstraZeneca (AZN), Shire (SHPG) and Roche (RHHBY) among European majors and Bristol-Myers (BMY) and Eli Lilly (LLY) in the U.S.

TODAY'S FREE FLY STORIES

HIIQ

Health Insurance Innovations

$24.10

-1.35 (-5.30%)

, WLTW

Willis Towers Watson

$145.08

-0.28 (-0.19%)

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Conference/Events
William Blair to hold a conference »

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HIIQ

Health Insurance Innovations

$24.10

-1.35 (-5.30%)

WLTW

Willis Towers Watson

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WING

Wingstop

$31.33

0.39 (1.26%)

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ALDR

Alder Biopharmaceuticals

$18.70

-1 (-5.08%)

08:21
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Technical Analysis
Technical View: Alder Biopharmaceuticals heads for 52-week low »

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SUNW

Sunworks

$1.94

0.03 (1.57%)

08:21
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MGPI

MGP Ingredients

$49.51

-0.06 (-0.12%)

, CKH

Seacor

$32.30

-0.3 (-0.92%)

08:21
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MGP Ingredients reaches agreement to sell stake in ICP JV »

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MGPI

MGP Ingredients

$49.51

-0.06 (-0.12%)

CKH

Seacor

$32.30

-0.3 (-0.92%)

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  • 13

    Jul

$DJT

DJ Transportation Average

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DJ Transportation Average: Pivot points »

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TEVA

Teva

$32.95

0.34 (1.04%)

, XENE

Xenon Pharmaceuticals

$3.80

-0.3 (-7.32%)

08:20
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Hot Stocks
Teva, Xenon says phase 2 study of topical TV-45070 did not meet primary endpoint »

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TEVA

Teva

$32.95

0.34 (1.04%)

XENE

Xenon Pharmaceuticals

$3.80

-0.3 (-7.32%)

03/08/13
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  • 30

    Aug

RICE

Rice Energy

$26.42

0.77 (3.00%)

08:20
06/27/17
06/27
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08:20
Downgrade
Rice Energy rating change  »

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$DJU

DJ Utility Average

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Technical Analysis
DJ Utility Average: Pivot points »

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DJX

Dow Jones Industrial Average

08:20
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Technical Analysis
Dow Jones Industrial Average: Pivot points »

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IYT

iShares Transportation Average

$169.98

0.86 (0.51%)

08:20
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Technical Analysis
iShares Transportation Average: Pivot points »

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08:20
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General news
Fedspeak from Chair Yellen is atop the roster »

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XLK

Technology Select Sector SPDR

$56.00

-0.3 (-0.53%)

08:19
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XLE

Energy Select Sector SPDR

$64.24

-0.14 (-0.22%)

08:19
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Technical Analysis
Energy Select Sector SPDR: Pivot points »

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XLY

Consumer Discretionary Sector SPDR

$89.84

0.32 (0.36%)

08:19
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Technical Analysis
Consumer Discretionary Sector SPDR: Pivot points »

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XLB

S&P Select Materials SPDR

$54.01

0.16 (0.30%)

08:19
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AGRX

Agile Therapeutics

$3.80

-0.04 (-1.04%)

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XLU

Utilities SPDR

$53.57

0.36 (0.68%)

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Utilities SPDR: Pivot points »

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CMCSA

Comcast

$39.59

0.09 (0.23%)

, CHTR

Charter

$332.65

1.85 (0.56%)

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CMCSA

Comcast

$39.59

0.09 (0.23%)

CHTR

Charter

$332.65

1.85 (0.56%)

S

Sprint

$8.01

-0.04 (-0.50%)

03/08/13
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  • 27

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  • 03

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XLP

Consumer Staples Sector SPDR

$55.71

0.22 (0.40%)

08:18
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Technical Analysis
Consumer Staples Sector SPDR: Pivot points »

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TEVA

Teva

$32.95

0.34 (1.04%)

, XENE

Xenon Pharmaceuticals

$3.80

-0.3 (-7.32%)

08:18
06/27/17
06/27
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08:18
Hot Stocks
Breaking Hot Stocks news story on Teva, Xenon Pharmaceuticals »

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TEVA

Teva

$32.95

0.34 (1.04%)

XENE

Xenon Pharmaceuticals

$3.80

-0.3 (-7.32%)

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  • 30

    Aug

XLV

Health Care Select Sector SPDR

$80.39

-0.08 (-0.10%)

08:18
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Technical Analysis
Health Care Select Sector SPDR: Pivot points »

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IWM

iShares Trust Russell 2000 Index Fund

$141.08

0.17 (0.12%)

08:18
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Technical Analysis
iShares Trust Russell 2000 Index Fund: Pivot points »

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DIA

Diamonds Fund ETF

$213.87

0.13 (0.06%)

08:17
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Technical Analysis
Diamonds Fund ETF: Pivot points »

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SPY

SPDR S&P 500 ETF Trust

$243.29

0.16 (0.07%)

08:17
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Technical Analysis
SPDR S&P 500 ETF Trust: Pivot points »

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