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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

NCSM

NCS Multistage

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CLDR

Cloudera

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General news
Japan's data dump revealed tepid inflation and mixed growth figures »

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AOS

A.O. Smith

$54.42

1.45 (2.74%)

20:16
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FB

Facebook

$147.70

1.14 (0.78%)

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Facebook improves 'Rights Manager' content protection system »

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AAWW

Atlas Air

$59.80

0.4 (0.67%)

20:11
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Atlas Air rating change at Stifel »

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UTHR

United Therapeutics

$120.50

0.51 (0.43%)

20:00
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United Therapeutics announces $250M repurchase program »

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  • 06

    Jun

CYTR

CytRx

$0.68

-0.121 (-15.02%)

19:56
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Hot Stocks
CytRx: Former 'SPA' for aldoxorubicin no longer applicable »

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  • 02

    Jun

EEX

Emerald Expositions Events

19:52
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Syndicate
Emerald Expositions Events 15.5M share IPO priced at $17.00 »

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  • 28

    Apr

GOOG

Alphabet

$874.25

2.52 (0.29%)

, GOOGL

Alphabet Class A

$891.44

2.3 (0.26%)

19:31
04/27/17
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Hot Stocks
Google introduces development kit for Google Assistant »

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GOOG

Alphabet

$874.25

2.52 (0.29%)

GOOGL

Alphabet Class A

$891.44

2.3 (0.26%)

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  • 27

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SRPT

Sarepta

$34.72

-0.14 (-0.40%)

19:26
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  • 27

    Apr

SRPT

Sarepta

$34.72

-0.14 (-0.40%)

19:22
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Sarepta: Guidance includes only U.S. sales »

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  • 27

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SRPT

Sarepta

$34.72

-0.14 (-0.40%)

19:20
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  • 27

    Apr

SRPT

Sarepta

$34.72

-0.14 (-0.40%)

19:18
04/27/17
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Hot Stocks
Sarepta confirms CEO Ed Kaye to resign from role at end of current term »

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  • 27

    Apr

BSAC

Santander Chile

$23.59

-0.36 (-1.50%)

19:02
04/27/17
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Earnings
Santander Chile reports Q1 EPS 46c, consensus 42c »

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  • 28

    Apr

BA

Boeing

$183.22

1.51 (0.83%)

, BDRBF

Bombardier

$1.63

-0.0278 (-1.67%)

19:01
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Canada gov't objects to Boeing allegations over Bombardier pricing in U.S. »

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BA

Boeing

$183.22

1.51 (0.83%)

BDRBF

Bombardier

$1.63

-0.0278 (-1.67%)

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  • 31

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BA

Boeing

$183.22

1.51 (0.83%)

, BDRBF

Bombardier

$1.63

-0.0278 (-1.67%)

18:56
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Periodicals
Boeing requests U.S. take action on Bombardier C series prices in U.S., FT says »

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BA

Boeing

$183.22

1.51 (0.83%)

BDRBF

Bombardier

$1.63

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  • 31

    May

SWN

Southwestern Energy

$7.67

-0.16 (-2.04%)

18:48
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Earnings
Southwestern Energy reports Q1 adjusted EPS 18c, consensus 18c »

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  • 28

    Apr

CRMD

CorMedix

$1.04

-0.07 (-6.31%)

18:43
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Syndicate
CorMedix files to sell common stock warrants, no amount given »

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  • 28

    Apr

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FET

Forum Energy

$18.10

-1.05 (-5.48%)

18:39
04/27/17
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Earnings
Breaking Earnings news story on Forum Energy »

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  • 28

    Apr

WDC

Western Digital

$85.71

1.1 (1.30%)

18:38
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  • 27

    Apr

FET

Forum Energy

$18.10

-1.05 (-5.48%)

18:38
04/27/17
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Earnings
Forum Energy reports Q1 adjusted EPS (14c), consensus (16c) »

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  • 28

    Apr

SJR

Shaw Communications

$21.30

0.07 (0.33%)

18:36
04/27/17
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Shaw Communications restores internet and phone services after brief outage »

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MTRX

Matrix Service

$16.88

-0.575 (-3.30%)

18:33
04/27/17
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Earnings
Breaking Earnings news story on Matrix Service »

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GIMO

Gigamon

$36.00

-0.6 (-1.64%)

18:33
04/27/17
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Earnings
Gigamon sees Q2 adjusted EPS 2c-7c, consensus 19c »

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