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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

HZNP

Horizon Pharma

$19.39

-0.82 (-4.06%)

06:57
12/08/16
12/08
06:57
12/08/16
06:57
Hot Stocks
Breaking Hot Stocks news story on Horizon Pharma »

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  • 08

    Dec

  • 14

    Dec

BLK

BlackRock

$377.52

5.84 (1.57%)

06:56
12/08/16
12/08
06:56
12/08/16
06:56
Periodicals
BlackRock signs preliminary deal to move to Manhattan's West Side, WSJ says »

BlackRock has signed a…

03/08/13
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AMD

AMD

$9.56

0.11 (1.16%)

06:56
12/08/16
12/08
06:56
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06:56
Upgrade
AMD rating change  »

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EVHC

Envision Healthcare

$69.19

-2.51 (-3.50%)

06:55
12/08/16
12/08
06:55
12/08/16
06:55
Initiation
Envision Healthcare initiated  »

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06:55
12/08/16
12/08
06:55
12/08/16
06:55
General news
NYMEX crude is showing a 0.8% gain »

NYMEX crude is showing a…

MEI

Methode Electronics

$39.00

0.45 (1.17%)

06:54
12/08/16
12/08
06:54
12/08/16
06:54
Earnings
Methode Electronics raises FY17 EPS view to $2.30-$2.45 from $2.11-$2.35 »

Consensus for FY17 EPS is…

03/08/13
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  • 08

    Dec

IGT

International Game

$25.49

0.36 (1.43%)

, SNE

Sony

$28.61

0.45 (1.60%)

06:54
12/08/16
12/08
06:54
12/08/16
06:54
Hot Stocks
International Game signs license agreement with Sony Pictures Television »

International Game…

IGT

International Game

$25.49

0.36 (1.43%)

SNE

Sony

$28.61

0.45 (1.60%)

03/08/13
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03/06/13
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03/06/13
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MEI

Methode Electronics

$39.00

0.45 (1.17%)

06:53
12/08/16
12/08
06:53
12/08/16
06:53
Earnings
Methode Electronics reports Q2 EPS 66c, consensus 55c »

Reports Q2 revenue…

03/08/13
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  • 08

    Dec

VRNT

Verint

$38.30

0.1 (0.26%)

06:52
12/08/16
12/08
06:52
12/08/16
06:52
Recommendations
Verint analyst commentary  »

Verint removed from Focus…

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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  • 08

    Dec

AMC

AMC Entertainment

$32.65

-1.15 (-3.40%)

, CKEC

Carmike Cinemas

$33.45

-0.4 (-1.18%)

06:49
12/08/16
12/08
06:49
12/08/16
06:49
Hot Stocks
AMC Entertainment and Carmike Cinemas announce election deadline »

AMC Theatres (AMC) and…

AMC

AMC Entertainment

$32.65

-1.15 (-3.40%)

CKEC

Carmike Cinemas

$33.45

-0.4 (-1.18%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
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SCBFF

Standard Chartered

$8.68

0.28 (3.33%)

06:47
12/08/16
12/08
06:47
12/08/16
06:47
Periodicals
StanChart sanctions investigation nearing completion, Bloomberg reports »

U.S. investigators have…

03/08/13
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HP

Helmerich & Payne

$80.86

0.94 (1.18%)

06:46
12/08/16
12/08
06:46
12/08/16
06:46
Downgrade
Helmerich & Payne rating change  »

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03/08/13
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03/06/13
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LULU

lululemon

$59.84

2.6 (4.54%)

06:45
12/08/16
12/08
06:45
12/08/16
06:45
Upgrade
lululemon rating change  »

lululemon upgraded to…

03/08/13
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  • 09

    Jan

PRGO

Perrigo

$83.94

-0.53 (-0.63%)

06:44
12/08/16
12/08
06:44
12/08/16
06:44
Hot Stocks
Perrigo announces portfolio review developments, intends to restructure BCH unit »

Perrigo announced its…

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03/06/13
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CEB

CEB

$59.50

0.35 (0.59%)

06:43
12/08/16
12/08
06:43
12/08/16
06:43
Downgrade
CEB rating change  »

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03/08/13
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UHS

Universal Health

$111.36

-15.01 (-11.88%)

06:42
12/08/16
12/08
06:42
12/08/16
06:42
Hot Stocks
Universal Health issues statement on recent BuzzFeed article »

Universal Health issued a…

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  • 08

    Dec

GOOGL

Alphabet Class A

$791.47

15.29 (1.97%)

, GOOG

Alphabet

$771.19

12.08 (1.59%)

06:42
12/08/16
12/08
06:42
12/08/16
06:42
Recommendations
Alphabet Class A, Alphabet, Facebook, Amazon.com analyst commentary  »

Citi replaces Amazon with…

GOOGL

Alphabet Class A

$791.47

15.29 (1.97%)

GOOG

Alphabet

$771.19

12.08 (1.59%)

FB

Facebook

$117.95

0.64 (0.55%)

AMZN

Amazon.com

$770.42

5.7 (0.75%)

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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  • 15

    Jan

SMG

Scotts Miracle-Gro

$92.84

2.01 (2.21%)

06:41
12/08/16
12/08
06:41
12/08/16
06:41
Upgrade
Scotts Miracle-Gro rating change  »

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ARAY

Accuray

06:40
12/08/16
12/08
06:40
12/08/16
06:40
Hot Stocks
Accuray reports first patients treated with new Radixact system »

Accuray announced that…

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  • 08

    Dec

TAX

Liberty Tax

$13.35

0.5 (3.89%)

06:38
12/08/16
12/08
06:38
12/08/16
06:38
Earnings
Liberty Tax reports Q2 EPS (72c), consensus (71c) »

Reports Q2 revenue $7.2M,…

03/08/13
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03/06/13
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  • 08

    Dec

ZEN

Zendesk

$21.15

-0.02 (-0.09%)

06:38
12/08/16
12/08
06:38
12/08/16
06:38
Conference/Events
Zendesk management to meet with William Blair »

Group luncheon with…

03/08/13
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  • 08

    Dec

AMZN

Amazon.com

$770.42

5.7 (0.75%)

06:38
12/08/16
12/08
06:38
12/08/16
06:38
Periodicals
Amazon seeks to help publishers profit more from ads, WSJ says »

Amazon is advancing…

03/08/13
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03/06/13
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03/06/13
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INFN

Infinera

$8.48

0.01 (0.12%)

06:37
12/08/16
12/08
06:37
12/08/16
06:37
Conference/Events
Infinera management to meet with William Blair »

Group luncheon with…

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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  • 08

    Dec

LLL

L-3 Communications

$161.56

3.1 (1.96%)

06:36
12/08/16
12/08
06:36
12/08/16
06:36
Downgrade
L-3 Communications rating change  »

L-3 Communications…

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BLL

Ball Corp.

$75.58

1.38 (1.86%)

06:34
12/08/16
12/08
06:34
12/08/16
06:34
Recommendations
Ball Corp. analyst commentary  »

Ball Corp. recent…

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  • 13

    Dec

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