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GSK

GlaxoSmithKline

$38.11

-0.34 (-0.88%)

, INVA

Innoviva

$10.91

-0.15 (-1.36%)

07:06
11/21/16
11/21
07:06
11/21/16
07:06

GlaxoSmithKline files regulatory submission for FF/UMEC/VI

GlaxoSmithKline (GSK) and Innoviva (INVA) announced the filing by GSK of a regulatory submission with the US FDA for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol for patients with chronic obstructive pulmonary disease. This follows the announcement earlier this year of plans to bring forward the timing of the U.S. filing from the first half of 2018. The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long- acting beta2-adrenergic agonist, delivered once-daily in GSK's Ellipta dry powder inhaler. The US regulatory submission of the closed triple therapy comprises a New Drug Application for the maintenance treatment of patients with COPD, including chronic bronchitis and emphysema. It is based on data from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination. A regulatory filing in the EU is planned in the coming weeks and is expected to be followed by submissions in other countries beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.

GSK

GlaxoSmithKline

$38.11

-0.34 (-0.88%)

INVA

Innoviva

$10.91

-0.15 (-1.36%)

  • 29

    Nov

GSK GlaxoSmithKline
$38.11

-0.34 (-0.88%)

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.
INVA Innoviva
$10.91

-0.15 (-1.36%)

10/31/16
COWN
10/31/16
UPGRADE
Target $15
COWN
Outperform
Innoviva upgraded to Outperform from Market Perform at Cowen
Cowen analyst Tyler Van Buren upgraded Innoviva to Outperform and raised its price target to $15 from $13 citing valuation discount and said the commercial prospects for Breo and Anoro remain stronger than ever heading into next year.

TODAY'S FREE FLY STORIES

AAPL

Apple

$176.19

-0.9 (-0.51%)

13:21
01/17/18
01/17
13:21
01/17/18
13:21
Hot Stocks
Apple to announce new U.S. campus location later this year »

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  • 01

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ICHR

Ichor Holdings

$25.60

0.86 (3.48%)

13:18
01/17/18
01/17
13:18
01/17/18
13:18
Recommendations
Ichor Holdings analyst commentary  »

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IPSEY

Ipsen

13:18
01/17/18
01/17
13:18
01/17/18
13:18
Hot Stocks
Ipsen: Onivyde+-FU/LV improved overall survival in Phase 3 study »

Ipsen Biopharmaceuticals,…

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  • 18

    Jan

$NSD

NASDAQ Market Internals

13:17
01/17/18
01/17
13:17
01/17/18
13:17
Technical Analysis
NASDAQ market internals summary »

Volume is above average…

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$NYE

NYSE Market Internals

13:16
01/17/18
01/17
13:16
01/17/18
13:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

03/08/13
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WFC

Wells Fargo

$63.42

0.92 (1.47%)

13:15
01/17/18
01/17
13:15
01/17/18
13:15
Hot Stocks
Wells Fargo announces retirement of chief risk officer Mike Loughlin »

Wells Fargo & Company…

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ACLS

Axcelis

$30.30

1.15 (3.95%)

, AMAT

Applied Materials

$54.50

1.05 (1.96%)

13:14
01/17/18
01/17
13:14
01/17/18
13:14
Recommendations
Axcelis, Applied Materials analyst commentary  »

Axcelis presentation an…

ACLS

Axcelis

$30.30

1.15 (3.95%)

AMAT

Applied Materials

$54.50

1.05 (1.96%)

03/08/13
Wedge Partners
03/08/13
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03/06/13
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03/06/13
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  • 17

    Jan

AVGO

Broadcom

$263.25

-1.04 (-0.39%)

13:12
01/17/18
01/17
13:12
01/17/18
13:12
Periodicals
Broadcom probed by FTC over negotiations with customers, WSJ reports »

The FTC is probing…

03/08/13
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SLM

Sallie Mae

$11.47

-0.24 (-2.05%)

13:08
01/17/18
01/17
13:08
01/17/18
13:08
Technical Analysis
Technical Earnings Preview: SLM Corp in middle of range before news »

Shares have been trading…

03/08/13
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  • 18

    Jan

AAPL

Apple

$176.19

-0.9 (-0.51%)

13:08
01/17/18
01/17
13:08
01/17/18
13:08
Hot Stocks
Apple announces new U.S. investments, sees $38B of repatriation taxes »

Apple announced a new set…

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  • 01

    Feb

13:05
01/17/18
01/17
13:05
01/17/18
13:05
General news
Treasury Action: early March bills continue to underperform »

Treasury Action: early…

FOX

21st Century Fox

$35.79

-0.58 (-1.59%)

, FOXA

21st Century Fox

$36.29

-0.44 (-1.20%)

13:04
01/17/18
01/17
13:04
01/17/18
13:04
Periodicals
FoxNext acquires game developer Cold Iron Studios, Polygon says »

FoxNext Games, the video…

FOX

21st Century Fox

$35.79

-0.58 (-1.59%)

FOXA

21st Century Fox

$36.29

-0.44 (-1.20%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
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  • 18

    Jan

  • 07

    Feb

  • 07

    Feb

AAPL

Apple

$176.19

-0.9 (-0.51%)

13:02
01/17/18
01/17
13:02
01/17/18
13:02
Hot Stocks
Breaking Hot Stocks news story on Apple »

Apple breaking ground…

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  • 01

    Feb

AAPL

Apple

$176.19

-0.9 (-0.51%)

13:01
01/17/18
01/17
13:01
01/17/18
13:01
Hot Stocks
Breaking Hot Stocks news story on Apple »

Apple sees investing over…

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03/08/13
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  • 01

    Feb

AAPL

Apple

$176.19

-0.9 (-0.51%)

13:01
01/17/18
01/17
13:01
01/17/18
13:01
Hot Stocks
Breaking Hot Stocks news story on Apple »

Apple announces new set…

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  • 01

    Feb

UPS

UPS

$133.62

0.74 (0.56%)

13:00
01/17/18
01/17
13:00
01/17/18
13:00
Options
Notable call spread in UPS as shares deliver profits »

Notable call spread in…

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AA

Alcoa

$56.35

0.11 (0.20%)

12:57
01/17/18
01/17
12:57
01/17/18
12:57
Technical Analysis
Technical Earnings Preview: Alcoa near 52-week high before news »

Ahead of earnings, the…

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  • 17

    Jan

AAPL

Apple

$176.19

-0.9 (-0.51%)

, BMWYY

BMW

$37.64

1.125 (3.08%)

12:51
01/17/18
01/17
12:51
01/17/18
12:51
Periodicals
BMW to offer CarPlay as subscription-based service next year, The Verge says »

BMW (BMWYY) plans to…

AAPL

Apple

$176.19

-0.9 (-0.51%)

BMWYY

BMW

$37.64

1.125 (3.08%)

03/08/13
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03/08/13
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03/06/13
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03/06/13
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  • 01

    Feb

TBT

ProShares UltraShort 20+ yr Trsry

$34.72

-0.06 (-0.17%)

12:50
01/17/18
01/17
12:50
01/17/18
12:50
Options
Closing puts in the ProShares UltraShort Longer-term Bond ETF »

Closing puts in the…

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12:50
01/17/18
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12:50
01/17/18
12:50
General news
U.S. equities extended their bounce »

U.S. equities extended…

ERJ

Embraer

$24.67

-0.1125 (-0.45%)

, BA

Boeing

$347.06

11.9016 (3.55%)

12:48
01/17/18
01/17
12:48
01/17/18
12:48
Periodicals
Embraer tells Bloomberg no guarantee Boeing talks with result in deal »

Embraer (ERJ), in an…

ERJ

Embraer

$24.67

-0.1125 (-0.45%)

BA

Boeing

$347.06

11.9016 (3.55%)

03/08/13
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  • 31

    Jan

  • 21

    Feb

ASML

ASML

$186.38

5.51 (3.05%)

, LRCX

Lam Research

$190.39

1.88 (1.00%)

12:46
01/17/18
01/17
12:46
01/17/18
12:46
Hot Stocks
ASML results pull semiconductor equipment maker shares higher »

Shares of semiconductor…

ASML

ASML

$186.38

5.51 (3.05%)

LRCX

Lam Research

$190.39

1.88 (1.00%)

KLAC

KLA-Tencor

$107.66

0.37 (0.34%)

AMAT

Applied Materials

$54.50

1.05 (1.96%)

TER

Teradyne

$46.51

1.2 (2.65%)

03/08/13
Wedge Partners
03/08/13
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03/06/13
Citigroup
03/06/13
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  • 17

    Jan

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    Jan

  • 25

    Jan

BCS

Barclays

$11.01

0.045 (0.41%)

12:45
01/17/18
01/17
12:45
01/17/18
12:45
Periodicals
Barclays slashes up to 100 senior investment bank staff, Bloomberg says »

Barclays is cutting up to…

03/08/13
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03/06/13
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KMI

Kinder Morgan

12:41
01/17/18
01/17
12:41
01/17/18
12:41
Technical Analysis
Technical Earnings Preview: Kinder Morgan in uptrend before results »

The stock has been…

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  • 17

    Jan

FB

Facebook

$178.39

-0.98 (-0.55%)

12:41
01/17/18
01/17
12:41
01/17/18
12:41
Hot Stocks
Facebook initiates new probe into possible Russian meddling around Brexit vote »

Facebook's U.K.…

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  • 17

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