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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

ALNY

Alnylam

$42.25

1.445 (3.54%)

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Breaking Hot Stocks news story on Alnylam »

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  • 16

    Dec

$NYE

NYSE Market Internals

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Technical Analysis
NYSE market internals summary »

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CVO

Cenveo

$6.84

-0.16 (-2.29%)

16:16
12/09/16
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16:16
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Hot Stocks
Breaking Hot Stocks news story on Cenveo »

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$NSD

NASDAQ Market Internals

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Technical Analysis
NASDAQ market internals summary »

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CLRB

Cellectar Biosciences

$1.33

-0.04 (-2.92%)

16:15
12/09/16
12/09
16:15
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16:15
Hot Stocks
Cellectar, INC Research enter into Work Order »

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INSW

International Seaways

$14.40

0.86 (6.35%)

16:12
12/09/16
12/09
16:12
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16:12
Hot Stocks
Breaking Hot Stocks news story on International Seaways »

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BFS

Saul Centers

$66.45

-0.96 (-1.42%)

16:09
12/09/16
12/09
16:09
12/09/16
16:09
Hot Stocks
Saul Centers raises quarterly dividend 8.5% to 51c from 47c per share »

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03/08/13
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ASNA

Ascena Retail

$8.04

-0.07 (-0.86%)

16:08
12/09/16
12/09
16:08
12/09/16
16:08
Hot Stocks
Ascena Retail names David Jaffe chairman of the board »

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MORN

Morningstar

16:08
12/09/16
12/09
16:08
12/09/16
16:08
Hot Stocks
Morningstar raises quarterly dividend to 23c from 22c per share »

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03/06/13
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SAND

Sandstorm Gold

$3.83

-0.19 (-4.73%)

16:07
12/09/16
12/09
16:07
12/09/16
16:07
Syndicate
Breaking Syndicate news story on Sandstorm Gold »

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ACIU

AC Immune

$14.93

2.88 (23.90%)

, RHHBY

Roche

$27.86

0.78 (2.88%)

16:05
12/09/16
12/09
16:05
12/09/16
16:05
Hot Stocks
AC Immune partner Genentech presents 'important' data on Alzheimer's therapy »

AC Immune (ACIU)…

ACIU

AC Immune

$14.93

2.88 (23.90%)

RHHBY

Roche

$27.86

0.78 (2.88%)

03/08/13
Wedge Partners
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Credit Suisse
03/06/13
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03/06/13
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MDVX

Medovex

$1.50

0.03 (2.04%)

16:03
12/09/16
12/09
16:03
12/09/16
16:03
Hot Stocks
Breaking Hot Stocks news story on Medovex »

Sorrento Therapeutics…

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BDC

Belden

$78.79

-1.69 (-2.10%)

16:01
12/09/16
12/09
16:01
12/09/16
16:01
Hot Stocks
Belden extends shareholder rights agreement »

Belden announced that it…

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GENE

Genetic Technologies

$1.19

-0.01 (-0.83%)

15:59
12/09/16
12/09
15:59
12/09/16
15:59
Hot Stocks
Breaking Hot Stocks news story on Genetic Technologies »

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FLO

Flowers Foods

$19.26

2.2325 (13.11%)

15:53
12/09/16
12/09
15:53
12/09/16
15:53
Recommendations
Flowers Foods analyst commentary  »

Flowers Foods settlement…

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HAL

Halliburton

$54.22

-0.21 (-0.39%)

15:50
12/09/16
12/09
15:50
12/09/16
15:50
Options
Halliburton Dec 48.5 puts for a nickel per contract »

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  • 23

    Jan

BIIB

Biogen

$289.54

4.24 (1.49%)

15:43
12/09/16
12/09
15:43
12/09/16
15:43
Recommendations
Biogen analyst commentary  »

Piper says Biogen still…

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VLO

Valero

$67.84

-0.535 (-0.78%)

15:40
12/09/16
12/09
15:40
12/09/16
15:40
Options
Higher option volume in Valero driven by downside put purchases »

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SKLN

Skyline Medical

$2.94

-0.01 (-0.34%)

15:36
12/09/16
12/09
15:36
12/09/16
15:36
Syndicate
Skyline Medical files to sell 1.925M units »

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HMNY

Helios and Matheson

$4.26

-0.08 (-1.84%)

15:35
12/09/16
12/09
15:35
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15:35
Hot Stocks
Farnsworth acquires 1.74M Helios and Matheson shares as part of merger pact »

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FLO

Flowers Foods

$19.10

2.07 (12.16%)

15:32
12/09/16
12/09
15:32
12/09/16
15:32
Upgrade
Flowers Foods rating change  »

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WBA

Walgreens Boots Alliance

$84.28

-0.71 (-0.84%)

, RAD

Rite Aid

$8.20

0.045 (0.55%)

15:25
12/09/16
12/09
15:25
12/09/16
15:25
Periodicals
Walgreens near finalizing Rite Aid divestiture package, CTFN reports »

Walgreens (WBA) is…

WBA

Walgreens Boots Alliance

$84.28

-0.71 (-0.84%)

RAD

Rite Aid

$8.20

0.045 (0.55%)

03/08/13
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  • 05

    Jan

BAS

Basic Energy

$0.44

-0.0039 (-0.89%)

15:19
12/09/16
12/09
15:19
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15:19
Hot Stocks
Breaking Hot Stocks news story on Basic Energy »

Basic Energy trading…

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$NYE

NYSE Market Internals

15:16
12/09/16
12/09
15:16
12/09/16
15:16
Technical Analysis
NYSE market internals summary »

Breadth is mixed with…

03/08/13
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03/06/13
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$NSD

NASDAQ Market Internals

15:16
12/09/16
12/09
15:16
12/09/16
15:16
Technical Analysis
NASDAQ market internals summary »

Volume is heavy for this…

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