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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

KMX

CarMax

$68.84

0.17 (0.25%)

, FINL

Finish Line

$9.22

-0.21 (-2.23%)

20:25
09/21/17
09/21
20:25
09/21/17
20:25
Earnings
Notable companies reporting before tomorrow's open »

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KMX

CarMax

$68.84

0.17 (0.25%)

FINL

Finish Line

$9.22

-0.21 (-2.23%)

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HPE

HP Enterprise

$13.79

0.16 (1.17%)

18:47
09/21/17
09/21
18:47
09/21/17
18:47
Periodicals
HP Enterprise planning approximately 5,000 job cuts, Bloomberg reports »

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RP

RealPage

$39.35

-0.1 (-0.25%)

18:41
09/21/17
09/21
18:41
09/21/17
18:41
Hot Stocks
RealPage expects $3M-$4M of renter's insurance claims from hurricanes »

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HPE

HP Enterprise

$13.79

0.16 (1.17%)

18:39
09/21/17
09/21
18:39
09/21/17
18:39
Periodicals
Breaking Periodicals news story on HP Enterprise »

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  • 07

    Dec

  • 11

    Dec

YUM

Yum! Brands

$76.48

0.11 (0.14%)

18:37
09/21/17
09/21
18:37
09/21/17
18:37
Conference/Events
Yum! Brands management to meet with JPMorgan »

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  • 27

    Sep

MAR

Marriott

$107.57

-0.12 (-0.11%)

18:32
09/21/17
09/21
18:32
09/21/17
18:32
Conference/Events
Marriott management to meet with JPMorgan »

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  • 27

    Sep

ESPGY

Esprit Holdings

$1.21

0.018 (1.51%)

18:29
09/21/17
09/21
18:29
09/21/17
18:29
Conference/Events
Esprit Holdings management to meet with JPMorgan »

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  • 27

    Sep

BA

Boeing

$256.04

0.58 (0.23%)

18:18
09/21/17
09/21
18:18
09/21/17
18:18
Hot Stocks
Boeing: Turkish Airlines announces intent to order 40 787-9 Dreamliners »

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  • 23

    Sep

M

Macy's

$21.16

-0.32 (-1.49%)

18:18
09/21/17
09/21
18:18
09/21/17
18:18
Conference/Events
Macy's management to meet with JPMorgan »

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  • 26

    Sep

  • 27

    Sep

TAHO

Tahoe Resources

$5.60

0.02 (0.36%)

18:12
09/21/17
09/21
18:12
09/21/17
18:12
Hot Stocks
Tahoe Resources raises 2017 gold operations view to 400K-500K »

Tahoe Resources updated…

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ATKR

Atkore

$18.42

0.02 (0.11%)

18:11
09/21/17
09/21
18:11
09/21/17
18:11
Conference/Events
Atkore management to meet with JPMorgan »

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  • 26

    Sep

YOGA

YogaWorks

$4.00

-0.04 (-0.99%)

, TXN

Texas Instruments

$86.05

0.22 (0.26%)

18:11
09/21/17
09/21
18:11
09/21/17
18:11
Hot Stocks
On The Fly: After Hours Movers »

UP AFTER EARNINGS:…

YOGA

YogaWorks

$4.00

-0.04 (-0.99%)

TXN

Texas Instruments

$86.05

0.22 (0.26%)

PSDO

Presidio

$13.95

-0.06 (-0.43%)

VSAR

Versartis

$21.60

-0.25 (-1.14%)

ASND

Ascendis Pharma

$27.74

-1.55 (-5.29%)

03/08/13
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  • 21

    Sep

  • 21

    Sep

FTR

Frontier Communications

$11.69

-0.31 (-2.58%)

18:10
09/21/17
09/21
18:10
09/21/17
18:10
Hot Stocks
Frontier Communications operations in Florida return to near-normal levels »

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PLYA

Playa Hotels & Resorts

$10.66

-0.06 (-0.56%)

18:07
09/21/17
09/21
18:07
09/21/17
18:07
Hot Stocks
Playa Hotels & Resorts reports no significant damage from Maria »

Playa Hotels &…

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  • 08

    Nov

ASND

Ascendis Pharma

$27.74

-1.55 (-5.29%)

, VSAR

Versartis

$21.60

-0.25 (-1.14%)

18:07
09/21/17
09/21
18:07
09/21/17
18:07
Hot Stocks
Ascendis spikes higher after Versartis Velocity trial fails to meet endpoint »

Shares of Ascendis Pharma…

ASND

Ascendis Pharma

$27.74

-1.55 (-5.29%)

VSAR

Versartis

$21.60

-0.25 (-1.14%)

03/08/13
Wedge Partners
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03/06/13
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03/06/13
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CE

Celanese

$103.90

-0.04 (-0.04%)

18:04
09/21/17
09/21
18:04
09/21/17
18:04
Hot Stocks
Celanese increases price of acetyl intermediates »

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DNOW

NOW Inc.

$12.98

0.1 (0.78%)

18:03
09/21/17
09/21
18:03
09/21/17
18:03
Conference/Events
NOW Inc. management to meet with JPMorgan »

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  • 25

    Sep

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  • 27

    Sep

  • 01

    Nov

JOBS

51job

$58.50

0.01 (0.02%)

18:02
09/21/17
09/21
18:02
09/21/17
18:02
Hot Stocks
51job announces strategic investment in Lagou »

51job announced that the…

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HES

Hess Corp.

$43.63

0.17 (0.39%)

17:53
09/21/17
09/21
17:53
09/21/17
17:53
Conference/Events
Hess Corp. management to meet with JPMorgan »

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  • 25

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  • 27

    Sep

APC

Anadarko

$48.49

3.68 (8.21%)

17:43
09/21/17
09/21
17:43
09/21/17
17:43
Recommendations
Anadarko analyst commentary at MUFG »

Anadarko buyback a…

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  • 27

    Sep

HCC

Warrior Met Coal

$23.28

-1.05 (-4.32%)

17:42
09/21/17
09/21
17:42
09/21/17
17:42
Hot Stocks
Warrior Met Coal receives favorable IRS private letter ruling »

Warrior Met Coal reported…

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MAA

MAA

$107.27

-0.03 (-0.03%)

17:35
09/21/17
09/21
17:35
09/21/17
17:35
Hot Stocks
MAA announces estimated impact of Hurricanes Irma and Harvey »

MAA announced that the…

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NOC

Northrop Grumman

$280.42

0.38 (0.14%)

17:31
09/21/17
09/21
17:31
09/21/17
17:31
Hot Stocks
Northrop Grumman awarded $124.7M government contract »

Northrop Grumman Systems…

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GD

General Dynamics

$205.72

1.45 (0.71%)

17:29
09/21/17
09/21
17:29
09/21/17
17:29
Hot Stocks
General Dynamics Electric Boat awarded $5B government contract »

General Dynamics Electric…

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AAN

Aaron's

$38.83

-0.39 (-0.99%)

17:19
09/21/17
09/21
17:19
09/21/17
17:19
Hot Stocks
Aaron's provides update on impact of Hurricane Irma »

Aaron's plans to…

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