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GSK

GlaxoSmithKline

$38.11

-0.34 (-0.88%)

, INVA

Innoviva

$10.91

-0.15 (-1.36%)

05:39
11/21/16
11/21
05:39
11/21/16
05:39

GSK, Innoviva files regulatory submission in U.S. for closed triple combination

GlaxoSmithKline (GSK) and Innoviva (INVA) announced the filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol, or FF/UMEC/VI 100/62.5/25 mcg, for patients with chronic obstructive pulmonary disease, or COPD. This follows the announcement earlier this year of plans to bring forward the timing of the US filing from the first half of 2018. The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid, or ICS, umeclidinium, a long-acting muscarinic antagonist, or LAMA, and vilanterol, a long-acting beta2-adrenergic agonist, or LABA, delivered once-daily in GSK's Ellipta dry powder inhaler. The U.S. 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.

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

DBOEY

Deutsche Boerse

$8.60

-0.045 (-0.52%)

18:26
02/26/17
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Deutsche Boerse sees European Commission merger decision by end of March »

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MESO

Mesoblast

$6.40

-0.14 (-2.14%)

18:23
02/26/17
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18:23
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Mesoblast outlines expected 2017 milestones »

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LIOX

Lionbridge

16:58
02/26/17
02/26
16:58
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16:58
Conference/Events
Lionbridge to host special shareholder meeting »

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CMCSA

Comcast

$37.89

0.24 (0.64%)

, CMCSK

Comcast

16:54
02/26/17
02/26
16:54
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16:54
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Box Office Battle: Comedy horror 'Get Out' thrills in $31M opening »

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CMCSA

Comcast

$37.89

0.24 (0.64%)

CMCSK

Comcast

TWX

Time Warner

$97.28

0.6225 (0.64%)

LGF.A

Lionsgate

$27.18

-0.08 (-0.29%)

LGF.B

Lionsgate

$25.16

-0.19 (-0.75%)

DIS

Disney

$110.32

0.59 (0.54%)

FOX

21st Century Fox

$30.23

0.23 (0.77%)

FOXA

21st Century Fox

$30.61

0.27 (0.89%)

VIA

Viacom

VIAB

Viacom

$43.89

0.03 (0.07%)

03/08/13
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03/08/13
Credit Suisse
03/06/13
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03/06/13
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  • 27

    Feb

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  • 06

    Mar

WAT

Waters

$156.40

1.51 (0.97%)

16:38
02/26/17
02/26
16:38
02/26/17
16:38
Conference/Events
Waters to host investor day »

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  • 02

    Mar

  • 01

    Apr

CR

Crane

$73.21

1.18 (1.64%)

16:36
02/26/17
02/26
16:36
02/26/17
16:36
Conference/Events
Crane to host investor day »

Investor Day to be held…

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  • 02

    Mar

DBOEY

Deutsche Boerse

$8.60

-0.045 (-0.52%)

16:34
02/26/17
02/26
16:34
02/26/17
16:34
Hot Stocks
LSE rejects European Commission merger demand, says unlikely to approve deal »

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BCO

Brink's

$52.00

0.7 (1.36%)

16:33
02/26/17
02/26
16:33
02/26/17
16:33
Conference/Events
Brink's to host investor day »

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  • 02

    Mar

XOM

Exxon Mobil

$81.08

-0.7 (-0.86%)

16:28
02/26/17
02/26
16:28
02/26/17
16:28
Conference/Events
Exxon Mobil to host analyst meeting with a conference call hook-up »

Analyst meeting to be…

03/08/13
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03/08/13
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03/06/13
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TXMD

TherapeuticsMD

$5.84

0.2 (3.55%)

16:22
02/26/17
02/26
16:22
02/26/17
16:22
Conference/Events
TherapeuticsMD to host investor day »

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03/08/13
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03/06/13
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  • 01

    Mar

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    Mar

  • 07

    May

MYL

Mylan

$42.16

-0.17 (-0.40%)

16:19
02/26/17
02/26
16:19
02/26/17
16:19
Conference/Events
Mylan to host investor day with a conference call hook-up »

CEO Bresch holds an…

03/08/13
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03/06/13
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03/06/13
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  • 01

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    Mar

  • 28

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  • 03

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  • 09

    Oct

MCD

McDonald's

$128.65

0.38 (0.30%)

16:16
02/26/17
02/26
16:16
02/26/17
16:16
Conference/Events
McDonald's to host investor meeting »

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HSY

Hershey

$108.90

0.25 (0.23%)

16:13
02/26/17
02/26
16:13
02/26/17
16:13
Conference/Events
Hershey to hold a webcast »

Incoming CEO Michelle…

03/08/13
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  • 01

    Mar

SSNLF

Samsung

, FB

Facebook

$135.44

0.08 (0.06%)

16:10
02/26/17
02/26
16:10
02/26/17
16:10
Hot Stocks
Samsung introduces Gear VR with controller »

Samsung (SSNLF) announced…

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Samsung

FB

Facebook

$135.44

0.08 (0.06%)

03/08/13
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03/06/13
Citigroup
03/06/13
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  • 27

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SSNLF

Samsung

16:08
02/26/17
02/26
16:08
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Hot Stocks
Samsung announces Galaxy Tab S3, Galaxy Book tablets »

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  • 19

    Mar

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SSNLF

Samsung

, HAR

Harman

$111.44

0.34 (0.31%)

16:06
02/26/17
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Hot Stocks
Samsung, Harman announce audio collaboration for Galaxy devices »

Samsung (SSNLF) and…

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Samsung

HAR

Harman

$111.44

0.34 (0.31%)

03/08/13
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  • 19

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EFX

Equifax

$129.38

0.16 (0.12%)

16:06
02/26/17
02/26
16:06
02/26/17
16:06
Conference/Events
Equifax management to meet with investors »

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  • 28

    Feb

  • 01

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MRK

Merck

$66.16

0.31 (0.47%)

16:03
02/26/17
02/26
16:03
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16:03
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Merck says Phase 3 letermovir study meets primary efficacy goal »

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  • 02

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  • 15

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  • 27

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    Jun

EFX

Equifax

$129.38

0.16 (0.12%)

16:03
02/26/17
02/26
16:03
02/26/17
16:03
Conference/Events
Equifax management to meet with investors »

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03/08/13
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  • 28

    Feb

NOK

Nokia

$5.14

-0.01 (-0.19%)

15:58
02/26/17
02/26
15:58
02/26/17
15:58
Hot Stocks
Nokia announces expanded portfolio of digital health products, solutions »

Nokia announced that the…

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  • 27

    Feb

  • 23

    May

TGT

Target

$66.51

1.53 (2.35%)

15:45
02/26/17
02/26
15:45
02/26/17
15:45
Conference/Events
Target to hold a financial community meeting »

Management holds 2017…

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  • 27

    Feb

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  • 19

    Mar

GPRO

GoPro

$9.43

-0.14 (-1.46%)

15:42
02/26/17
02/26
15:42
02/26/17
15:42
Hot Stocks
GoPro says 'Quik' app chosen by Huawei for latest devices »

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  • 28

    Feb

LGND

Ligand

$100.38

-2.46 (-2.39%)

15:40
02/26/17
02/26
15:40
02/26/17
15:40
Conference/Events
Ligand to host analyst day »

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  • 28

    Feb

  • 02

    Mar

HURN

Huron

$44.30

-0.8 (-1.77%)

15:39
02/26/17
02/26
15:39
02/26/17
15:39
Conference/Events
Huron to host investor day »

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03/08/13
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  • 28

    Feb

ENS

EnerSys

$75.98

-0.77 (-1.00%)

15:36
02/26/17
02/26
15:36
02/26/17
15:36
Conference/Events
EnerSys to host investor day »

Investor Day to be held…

03/08/13
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  • 28

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