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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

  • 03

    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.

TODAY'S FREE FLY STORIES

BMY

Bristol-Myers

$62.28

0.45 (0.73%)

15:26
01/20/18
01/20
15:26
01/20/18
15:26
Hot Stocks
Opdivo, Yervoy combo demonstrates activity in patients with dMMR, MSI-H mCRC »

Bristol-Myers Squibb…

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    Mar

EXEL

Exelixis

$28.00

0.14 (0.50%)

, RHHBY

Roche

$30.69

0.18 (0.59%)

15:22
01/20/18
01/20
15:22
01/20/18
15:22
Hot Stocks
Exelixis presents updated results from Phase 1b clinical trial in CRC »

Exelixis (EXEL) announced…

EXEL

Exelixis

$28.00

0.14 (0.50%)

RHHBY

Roche

$30.69

0.18 (0.59%)

03/08/13
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03/06/13
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ARRY

Array BioPharma

$13.14

0.26 (2.02%)

15:17
01/20/18
01/20
15:17
01/20/18
15:17
Hot Stocks
Array BioPharma updates results from BEACON Phase 3 trial »

Array BioPharma and…

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SO

Southern Company

$44.44

-0.46 (-1.02%)

15:13
01/20/18
01/20
15:13
01/20/18
15:13
Hot Stocks
Southern Company accelerates restoration efforts in Puerto Rico »

Southern Company…

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TECK

Teck Resources

$29.43

0.19 (0.65%)

15:10
01/20/18
01/20
15:10
01/20/18
15:10
Hot Stocks
Teck Resources announces Elkview incident »

Teck Resources announced…

03/08/13
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03/06/13
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  • 14

    Feb

TWTR

Twitter

$23.66

-0.38 (-1.58%)

14:03
01/20/18
01/20
14:03
01/20/18
14:03
Hot Stocks
Twitter begins notifying users exposed to Russian propaganda during elections »

Twitter, which is…

03/08/13
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03/08/13
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03/06/13
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  • 23

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    Feb

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    Feb

SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

, SPX

S&P 500

13:58
01/20/18
01/20
13:58
01/20/18
13:58
Periodicals
Government shuts down on anniversary of Trump presidency, Reuters reports »

President's Trump…

SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

SPX

S&P 500

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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FB

Facebook

$181.29

1.49 (0.83%)

, NYT

New York Times

$21.90

1.7 (8.42%)

13:48
01/20/18
01/20
13:48
01/20/18
13:48
Periodicals
NY Times stock jumps after Facebook's announcement, Recode reports »

Facebook (FB) CEO Mark…

FB

Facebook

$181.29

1.49 (0.83%)

NYT

New York Times

$21.90

1.7 (8.42%)

NWSA

News Corp.

$17.22

0.21 (1.23%)

FOXA

21st Century Fox

$36.65

0.47 (1.30%)

03/08/13
Wedge Partners
03/08/13
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03/06/13
Citigroup
03/06/13
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WMT

Walmart

$104.59

0.29 (0.28%)

13:36
01/20/18
01/20
13:36
01/20/18
13:36
Periodicals
Still time to shop Walmart shares as company makes changes, Barron's says »

In a follow-up story,…

03/08/13
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03/08/13
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03/06/13
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  • 20

    Feb

AAPL

Apple

$178.46

-0.8 (-0.45%)

, NFLX

Netflix

$220.46

0.13 (0.06%)

08:59
01/20/18
01/20
08:59
01/20/18
08:59
Periodicals
Netflix among likely candidates for an Apple purchase, Barron's says »

Especially for tech…

AAPL

Apple

$178.46

-0.8 (-0.45%)

NFLX

Netflix

$220.46

0.13 (0.06%)

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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  • 22

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BA

Boeing

$337.73

-2.43 (-0.71%)

08:50
01/20/18
01/20
08:50
01/20/18
08:50
Periodicals
Boeing not a sell just yet, Barron's says »

Boeing stock has come…

03/08/13
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  • 31

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AAPL

Apple

$178.46

-0.8 (-0.45%)

, EADSY

Airbus

$28.43

0.755 (2.73%)

08:24
01/20/18
01/20
08:24
01/20/18
08:24
Hot Stocks
Week in review: How Trump's policies moved stocks »

Catch up on the top…

AAPL

Apple

$178.46

-0.8 (-0.45%)

EADSY

Airbus

$28.43

0.755 (2.73%)

BA

Boeing

$337.73

-2.43 (-0.71%)

VZ

Verizon

$51.91

0.36 (0.70%)

NYT

New York Times

$21.90

1.7 (8.42%)

TWX

Time Warner

$93.36

0.39 (0.42%)

DIS

Disney

$110.59

0.17 (0.15%)

TIME

Time Inc.

$18.55

0.05 (0.27%)

AMZN

Amazon.com

$1,294.58

1.26 (0.10%)

BAC

Bank of America

$31.72

0.24 (0.76%)

GS

Goldman Sachs

$256.12

5.15 (2.05%)

BK

BNY Mellon

$56.61

1.26 (2.28%)

WLKP

Westlake Chemical Partners

$24.45

-0.1 (-0.41%)

MON

Monsanto

$120.66

1.8 (1.51%)

DLTR

Dollar Tree

$114.73

1.83 (1.62%)

CE

Celanese

$112.96

1.93 (1.74%)

LYB

LyondellBasell

$119.92

3.03 (2.59%)

TSE

Trinseo

$79.45

2.2 (2.85%)

EYE

National Vision

$43.13

1.12 (2.67%)

ETFC

E-Trade

$54.28

0.63 (1.17%)

LPLA

LPL Financial

$59.03

0.53 (0.91%)

AMTD

TD Ameritrade

$55.17

0.21 (0.38%)

SCHW

Charles Schwab

$55.48

0.15 (0.27%)

ADS

Alliance Data

$261.82

5.88 (2.30%)

FISV

Fiserv

$138.11

0.17 (0.12%)

FLT

FleetCor

$206.65

3.4 (1.67%)

HAWK

Blackhawk

$45.25

0.1 (0.22%)

MTZ

MasTec

$53.30

1.25 (2.40%)

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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CME

CME Group

$154.28

2.07 (1.36%)

, GS

Goldman Sachs

$256.12

5.15 (2.05%)

04:55
01/20/18
01/20
04:55
01/20/18
04:55
Conference/Events
American Bar Association to hold annual meeting »

Derivatives & Futures…

CME

CME Group

$154.28

2.07 (1.36%)

GS

Goldman Sachs

$256.12

5.15 (2.05%)

BP

BP

$42.40

-0.5 (-1.17%)

C

Citi

$78.30

0.91 (1.18%)

BAC

Bank of America

$31.72

0.24 (0.76%)

CS

Credit Suisse

$19.06

0.13 (0.69%)

CRL

Charles River

$107.89

1.22 (1.14%)

MS

Morgan Stanley

$57.46

1.62 (2.90%)

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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  • 20

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    Feb

AMGN

Amgen

$189.28

1.69 (0.90%)

, BAYRY

Bayer

$32.05

0.235 (0.74%)

04:55
01/20/18
01/20
04:55
01/20/18
04:55
Conference/Events
American Society of Clinical Oncology to hold a symposium »

2018 ASCO…

AMGN

Amgen

$189.28

1.69 (0.90%)

BAYRY

Bayer

$32.05

0.235 (0.74%)

BLRX

BioLineRx

$1.09

-0.02 (-1.80%)

BMY

Bristol-Myers

$62.28

0.45 (0.73%)

CELG

Celgene

$102.65

0.93 (0.91%)

DNA

Bought by RHHBY

ESALY

Eisai

$56.88

0.115 (0.20%)

EXEL

Exelixis

$28.00

0.14 (0.50%)

HALO

Halozyme

$17.98

0.13 (0.73%)

INCY

Incyte

$93.16

1.24 (1.35%)

IPSEY

Ipsen

$34.65

0.75 (2.21%)

LXRX

Lexicon

$10.44

0.2 (1.95%)

MGNX

MacroGenics

$19.19

0.3 (1.59%)

MRK

Merck

$61.28

0.15 (0.25%)

NVS

Novartis

$86.94

0.53 (0.61%)

SNY

Sanofi

$44.60

0.09 (0.20%)

ONCY

Oncolytics

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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WLFC

Willis Lease

$26.66

0.05 (0.19%)

18:59
01/19/18
01/19
18:59
01/19/18
18:59
Hot Stocks
Willis Lease announces $1,000 bonus for employees »

Willis Lease announced…

03/08/13
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DPS

Dr Pepper Snapple

$96.35

1.03 (1.08%)

18:13
01/19/18
01/19
18:13
01/19/18
18:13
Hot Stocks
Dr Pepper to become official sponsor of esports team TSM »

Dr Pepper announced it is…

03/08/13
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RCII

Rent-A-Center

$11.70

0.09 (0.78%)

17:53
01/19/18
01/19
17:53
01/19/18
17:53
Hot Stocks
Vintage Capital in standstill pact with Rent-A-Center »

On January 17, Vintage…

03/08/13
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AR

Antero Resources

$18.74

-0.59 (-3.05%)

17:44
01/19/18
01/19
17:44
01/19/18
17:44
Recommendations
Antero Resources analyst commentary at MUFG »

Antero Resources price…

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T

AT&T

$37.21

0.06 (0.16%)

, TWX

Time Warner

$93.36

0.39 (0.42%)

17:44
01/19/18
01/19
17:44
01/19/18
17:44
Periodicals
AT&T requesting docs from companies in Time Warner deal hearing, Reuters says »

AT&T (T) is…

T

AT&T

$37.21

0.06 (0.16%)

TWX

Time Warner

$93.36

0.39 (0.42%)

VZ

Verizon

$51.91

0.36 (0.70%)

CMCSA

Comcast

$42.50

0.65 (1.55%)

CMCSK

Comcast

DISH

Dish

$45.26

0.1 (0.22%)

CHTR

Charter

$366.05

0.8 (0.22%)

DIS

Disney

$110.59

0.17 (0.15%)

VIA

Viacom

$39.20

-0.5 (-1.26%)

VIAB

Viacom

$33.36

-0.59 (-1.74%)

03/08/13
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03/08/13
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03/06/13
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    Feb

GRPN

Groupon

$5.57

0.46 (9.00%)

17:44
01/19/18
01/19
17:44
01/19/18
17:44
Hot Stocks
Groupon announces Chief Product Officer Jay Sullivan resigns »

On January 17, Jay…

03/08/13
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CELG

Celgene

$102.65

0.93 (0.91%)

17:41
01/19/18
01/19
17:41
01/19/18
17:41
Hot Stocks
Celgene's Abraxane exceeds primary endpoint target in pancreatic cancer trial »

Celgene announced primary…

03/08/13
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03/06/13
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VALU

Value Line

$19.60

0.3 (1.55%)

17:40
01/19/18
01/19
17:40
01/19/18
17:40
Hot Stocks
Value Line reaffirms $3M stock repurchase program »

The Board of Directors…

03/08/13
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VALU

Value Line

$19.60

0.3 (1.55%)

17:39
01/19/18
01/19
17:39
01/19/18
17:39
Hot Stocks
Value Line declares special dividend of 20c per share »

Payable on March 9 to…

03/08/13
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ZEAL

Zealand Pharma

$15.05

-0.78 (-4.93%)

17:34
01/19/18
01/19
17:34
01/19/18
17:34
Hot Stocks
Zealand Pharma: FDA approves IND for Phase 3 trials of dasiglucagon in CHI »

The U.S. FDA has approved…

03/08/13
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GNMSF

Genmab

$190.75

2.75 (1.46%)

, JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

17:29
01/19/18
01/19
17:29
01/19/18
17:29
Hot Stocks
Genmab says FDA grants priority review for daratumumab »

Genmab (GNMSF) announced…

GNMSF

Genmab

$190.75

2.75 (1.46%)

JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

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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