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MRK

Merck

$62.21

0.57 (0.92%)

07:01
11/28/16
11/28
07:01
11/28/16
07:01

Merck's sBLA for Keytruda granted priority review by FDA

Merck announced that the U.S. FDA accepted for review the supplemental Biologics License Application for KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high cancer. The FDA granted Priority Review with a PDUFA, or target action date, of March 8, 2017; the sBLA will be reviewed under the FDA's Accelerated Approval program based on tumor response rate and durability of response. The FDA recently granted Breakthrough Therapy Designation to KEYTRUDA for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer. The application, which is seeking approval for KEYTRUDA at a fixed dose of 200 mg every three weeks, is based on data from five uncontrolled, open-label, multi-cohort, multi-site phase I/II trials investigating the activity of KEYTRUDA in MSI-H cancer.

  • 29

    Nov

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    Dec

MRK Merck
$62.21

0.57 (0.92%)

10/13/16
10/13/16
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Merck (MRK) upgraded to Buy from Neutral at BofA/Merrill with analyst Colin Bristow citing its opportunity in first line lung cancer. 2. Viacom (VIA, VIAB) upgraded to Market Perform from Underperform at Wells Fargo and to Buy from Underperform at BofA/Merrill. 3. TD Ameritrade (AMTD) and Charles Schwab (SCHW) were upgraded to Buy from Neutral at BofA/Merrill. 4. Talend (TLND) upgraded to Buy from Neutral at Goldman with analyst Jesse Hulsing saying the company will benefit from analytic workloads moving to the cloud. 5. CSC (CSC) upgraded to Buy from Neutral at Citi. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/19/16
LEER
10/19/16
NO CHANGE
LEER
Roche Tecentriq approval increases competition, says Leerink
Leerink analyst Seamus Fernandez says that the FDA approval of Roche's (RHHBY) Tecentriq in second-line non-small cell lung cancer patients regardless of PD-L1 expression comes as no surprise given its previously reported overall survival advantage. Nonetheless, the analyst believes it creates new competition for Bristol-Myers' (BMY) Opdivo and Merck's (MRK) Keytruda in this setting.
10/24/16
RHCO
10/24/16
NO CHANGE
RHCO
Merck Keytruda to have several positive catalysts, says SunTrust
SunTrust analyst John Boris says that several trials of Merck's Keytruda will be stopped early "across multiple tumor types," providing a positive catalyst. Boris says that Keytruda should be approved for 1LNSCLC on or before December 24 and KN-21 chemo combo compendium listing in 1H17. He keeps a $73 price target and Buy rating on Merck.
10/25/16
RHCO
10/25/16
NO CHANGE
RHCO
Merck shares should be bought after early FDA approval, says SunTrust
After Merck announced that the FDA had approved the company's Keytruda treatment for the first-line metastatic non-small cell lung cancer with tumor proportion scores of 50% or higher, SunTrust analyst John Boris says that such patients represent about 30% "of the prevalent first-line population." He adds that the approval was earlier than expected and gives Keytruda an approximately 15 month lead over competing drugs in NSCLC. The analyst thinks that the early approval will enable the company's 2021 revenue to beat expectations by a significant amount, and he recommends buying the stock on the news.

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JCP

J.C. Penney

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SAM

Boston Beer

$159.20

1.3 (0.82%)

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Boston Beer looks expensive, Barron's says »

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AXTA

Axalta Coating

$29.38

-0.09 (-0.31%)

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GPN

Global Payments

$78.97

0.76 (0.97%)

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RIG

Transocean

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-0.56 (-3.91%)

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Transocean could rally 35% or more over next several years, Barron's says »

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TV

Grupo Televisa

$26.44

0.69 (2.68%)

12:57
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HOG

Harley-Davidson

$56.56

-1.12 (-1.94%)

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LIFE

aTyr Pharma

$3.38

-0.05 (-1.46%)

12:29
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FDA grants Orphan designation for aTyr Pharma muscular dystrophy product »

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AGU

Agrium

$99.37

-1.19 (-1.18%)

, AAL

American Airlines

$46.28

0.18 (0.39%)

04:55
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04:55
Conference/Events
BMO Capital to hold a conference »

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AGU

Agrium

$99.37

-1.19 (-1.18%)

AAL

American Airlines

$46.28

0.18 (0.39%)

ABX

Barrick Gold

$19.54

-0.12 (-0.61%)

AEM

Agnico Eagle

$45.32

-0.06 (-0.13%)

ANTO

Use ANFGY

BLT

Blount

CCO

Clear Channel Outdoor

$4.65

0.1797 (4.02%)

FCX

Freeport McMoRan

$13.25

-0.23 (-1.71%)

FNV

Franco-Nevada

$65.89

-0.85 (-1.27%)

GEM

Pepsi-Gemex ADR

$29.39

-0.3 (-1.01%)

GG

Goldcorp

$16.57

-0.25 (-1.49%)

HBM

Hudbay Minerals

$8.00

0.25 (3.23%)

IVN

trades under IVPAF

NUE

Nucor

$60.86

-0.03 (-0.05%)

PDL

Project Design Labs

POT

Potash

$17.87

-0.2 (-1.11%)

RIO

Rio Tinto

$41.69

-0.82 (-1.93%)

SLW

Silver Wheaton

$21.15

-0.36 (-1.67%)

STLD

Steel Dynamics

$35.59

0.07 (0.20%)

TECK

Teck Resources

$20.72

-0.09 (-0.43%)

NEM

Newmont Mining

$36.08

0.22 (0.61%)

MOS

Mosaic

$31.42

-0.41 (-1.29%)

AA

Alcoa

$34.48

0.16 (0.47%)

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AGU

Agrium

$99.37

-1.19 (-1.18%)

, AAL

American Airlines

$46.28

0.18 (0.39%)

16:10
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Conference/Events
BMO Capital to hold a conference »

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AGU

Agrium

$99.37

-1.19 (-1.18%)

AAL

American Airlines

$46.28

0.18 (0.39%)

ABX

Barrick Gold

$19.54

-0.12 (-0.61%)

AEM

Agnico Eagle

$45.32

-0.06 (-0.13%)

ANTO

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BLT

Blount

CCO

Clear Channel Outdoor

$4.65

0.1797 (4.02%)

FCX

Freeport McMoRan

$13.25

-0.23 (-1.71%)

FNV

Franco-Nevada

$65.89

-0.85 (-1.27%)

GEM

Pepsi-Gemex ADR

$29.39

-0.3 (-1.01%)

GG

Goldcorp

$16.57

-0.25 (-1.49%)

HBM

Hudbay Minerals

$8.00

0.25 (3.23%)

IVN

trades under IVPAF

NUE

Nucor

$60.86

-0.03 (-0.05%)

PDL

Project Design Labs

POT

Potash

$17.87

-0.2 (-1.11%)

RIO

Rio Tinto

$41.69

-0.82 (-1.93%)

SLW

Silver Wheaton

$21.15

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STLD

Steel Dynamics

$35.59

0.07 (0.20%)

TECK

Teck Resources

$20.72

-0.09 (-0.43%)

NEM

Newmont Mining

$36.08

0.22 (0.61%)

MOS

Mosaic

$31.42

-0.41 (-1.29%)

AA

Alcoa

$34.48

0.16 (0.47%)

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SO

Southern Company

$50.50

0.83 (1.67%)

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Southern Company participates in a conference call with Wolfe Research »

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DK

Delek US

$23.19

-0.21 (-0.90%)

15:04
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Conference/Events
Delek US management participates in a dinner meeting with Wolfe Research »

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  • 28

    Feb

ANTM

Anthem

$163.83

-0.09 (-0.05%)

15:00
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02/25
15:00
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Conference/Events
Anthem management to meet with Wolfe Research »

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  • 28

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MCO

Moody's

$113.29

0.06 (0.05%)

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  • 02

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ONCS

OncoSec

$1.39

-0.03 (-2.11%)

, NKTR

Nektar

$13.45

0.25 (1.89%)

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American Society of Clinical Oncology to hold a symposium »

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ONCS

OncoSec

$1.39

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NKTR

Nektar

$13.45

0.25 (1.89%)

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  • 28

    Feb

MMM

3M

$187.41

0.22 (0.12%)

, BIOL

BIOLASE

$1.49

-0.01 (-0.67%)

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Chicago Dental Society to hold a meeting »

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MMM

3M

$187.41

0.22 (0.12%)

BIOL

BIOLASE

$1.49

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COF

Capital One

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RNECY

Renesas

$4.14

-0.17 (-3.94%)

, ISIL

Intersil

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Renesas sees Intersil acquisition accretive to non-GAAP EPS, free cash flows »

Renesas Electronics…

RNECY

Renesas

$4.14

-0.17 (-3.94%)

ISIL

Intersil

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HSIC

Henry Schein

$173.53

1.61 (0.94%)

18:45
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Henry Schein management to meet with Jefferies »

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  • 24

    Feb

TWX

Time Warner

$97.28

0.6225 (0.64%)

18:38
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Periodicals
Turner, Univision to win U.S. Champions League rights, Bloomberg reports »

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  • 06

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TRUE

TrueCar

$14.28

0.18 (1.28%)

18:33
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TrueCar's ALG sees February total new vehicle sales 1.325M units, down 1.4% »

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  • 27

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GE

General Electric

$30.19

0.17 (0.57%)

18:24
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GE does not see after-tax charges from GE Capital exit plan to exceed $23B »

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  • 26

    Apr

CE

Celanese

$88.79

-0.88 (-0.98%)

18:02
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Celanese announces vinyl acetate-based emulsions price increases in Asia »

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  • 28

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ELNK

EarthLink

$5.63

-0.22 (-3.76%)

, WIN

Windstream

$7.27

-0.02 (-0.27%)

17:56
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EarthLink, Windstream holders approve merger »

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ELNK

EarthLink

$5.63

-0.22 (-3.76%)

WIN

Windstream

$7.27

-0.02 (-0.27%)

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PFE

Pfizer

$34.26

0.2 (0.59%)

17:43
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Periodicals
Pfizer subpoenaed in investigation of charity connections, Bloomberg says »

Pfizer has received two…

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