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MRK

Merck

$61.19

-1 (-1.61%)

07:05
12/01/16
12/01
07:05
12/01/16
07:05

Merck says FDA grants priority review to sBLA for Keytruda in relapsed cHL

Merck announced that the U.S. FDA has accepted for review the supplemental Biologics License Application for KEYTRUDA, the company's anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for patients who have relapsed after three or more prior lines of therapy. The FDA granted Priority Review with a PDUFA, or target action, date of March 15, 2017. The sBLA will be reviewed under the FDA's Accelerated Approval program. In April 2016, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this indication. The application is seeking approval for KEYTRUDA at a fixed dose of 200 mg administered intravenously every three weeks and is based on data from the KEYNOTE-087 and KEYNOTE-013 trials, which studied patients with refractory cHL or who had relapsed after three or more prior lines of therapy. This is the first application for regulatory approval of KEYTRUDA in a hematologic malignancy. The KEYTRUDA clinical development program includes more than 30 tumor types in more than 360 clinical trials, including nearly 200 trials that combine KEYTRUDA with other cancer treatments. For hematologic malignancies specifically, Merck is conducting broad immuno-oncology research assessing the role of monotherapy and combination regimens with KEYTRUDA. The program includes nearly 40 ongoing studies - several of which are registration-enabling trials - across more than 20 hematologic subtypes, including leukemia, lymphomas and myeloma.

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MRK Merck
$61.19

-1 (-1.61%)

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

RHHBY

Roche

$27.67

0.47 (1.73%)

20:25
12/05/16
12/05
20:25
12/05/16
20:25
Conference/Events
Roche to hold an analyst meeting »

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  • 05

    Dec

AZO

AutoZone

$776.42

-7.32 (-0.93%)

, HDS

HD Supply

$39.75

0.67 (1.71%)

20:25
12/05/16
12/05
20:25
12/05/16
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

AZO

AutoZone

$776.42

-7.32 (-0.93%)

HDS

HD Supply

$39.75

0.67 (1.71%)

MIK

Michaels

$24.31

0.34 (1.42%)

TOL

Toll Brothers

$30.47

1.15 (3.92%)

BOBE

Bob Evans

$46.77

1.05 (2.30%)

CONN

Conn's

$11.20

0.4 (3.70%)

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GDDY

GoDaddy

$34.74

1.45 (4.36%)

20:14
12/05/16
12/05
20:14
12/05/16
20:14
Hot Stocks
GoDaddy acquires WP Curve »

WP Curve announced it has…

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BDC

Belden

$74.99

0.9 (1.21%)

20:10
12/05/16
12/05
20:10
12/05/16
20:10
Earnings
Belden sees FY17 adjusted EPS $5.00-$5.25, consensus $5.23 »

Sees FY17 revenue…

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  • 05

    Dec

SGMO

Sangamo

19:39
12/05/16
12/05
19:39
12/05/16
19:39
Hot Stocks
Sangamo reports preclinical, manufacturing data on SB-525, says IND on track »

Sangamo BioSciences…

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  • 05

    Dec

SGEN

Seattle Genetics

$66.26

-0.44 (-0.66%)

, BMY

Bristol-Myers

$55.55

-0.41 (-0.73%)

19:38
12/05/16
12/05
19:38
12/05/16
19:38
Hot Stocks
Seattle Genetics, Bristol-Myers: Data supports ADCETRIS, Opdivo combo »

Seattle Genetics (SGEN)…

SGEN

Seattle Genetics

$66.26

-0.44 (-0.66%)

BMY

Bristol-Myers

$55.55

-0.41 (-0.73%)

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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LGIH

LGI Homes

$32.34

0.45 (1.41%)

19:36
12/05/16
12/05
19:36
12/05/16
19:36
Hot Stocks
LGI Homes reports November home closings up 28.9% y/y »

LGI Homes announced 321…

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CELG

Celgene

$116.56

-1.07 (-0.91%)

19:36
12/05/16
12/05
19:36
12/05/16
19:36
Hot Stocks
Celgene reports analysis of three CC-486 studies »

Celgene announced results…

03/08/13
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  • 06

    Dec

BLUE

bluebird bio

$72.15

2.4 (3.44%)

19:35
12/05/16
12/05
19:35
12/05/16
19:35
Hot Stocks
bluebird bio provides updates on HSC gene therapy programs »

bluebird bio provided…

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AGIO

Agios Pharmaceuticals

$49.88

-7.09 (-12.45%)

19:33
12/05/16
12/05
19:33
12/05/16
19:33
Hot Stocks
Agios 'encouraged' by durable clinical activity of AG-120 »

Agios Pharmaceuticals…

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MRK

Merck

$60.25

-0.88 (-1.44%)

19:31
12/05/16
12/05
19:31
12/05/16
19:31
Hot Stocks
Merck: KEYNOTE-087 trial data shows oORR of 69%, CRR of 22.4% »

Merck announced updated…

03/08/13
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TWX

Time Warner

$93.34

-0.46 (-0.49%)

, T

AT&T

$38.63

0.02 (0.05%)

19:29
12/05/16
12/05
19:29
12/05/16
19:29
Periodicals
Time Warner 'struggling to expand' HBO Now, NY Post says »

Time Warner (TWX) is…

TWX

Time Warner

$93.34

-0.46 (-0.49%)

T

AT&T

$38.63

0.02 (0.05%)

03/08/13
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BP

BP

, REPYY

Repsol

$13.88

0.25 (1.83%)

19:18
12/05/16
12/05
19:18
12/05/16
19:18
Periodicals
BP acquires Repsol stake in Indonesia LNG plant, Reuters says »

BP (BP) has purchased…

BP

BP

REPYY

Repsol

$13.88

0.25 (1.83%)

03/08/13
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FOSUF

Fosun

19:12
12/05/16
12/05
19:12
12/05/16
19:12
Hot Stocks
Liberty Mutual to acquire Fosun subsidiary Ironshore for roughly $3B »

Liberty Mutual Insurance…

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VZ

Verizon

$49.75

-0.06 (-0.12%)

, YHOO

Yahoo

$40.20

0.13 (0.32%)

18:54
12/05/16
12/05
18:54
12/05/16
18:54
Periodicals
AOL CEO 'cautiously optimistic' Verizon-Yahoo deal will go through, WSJ says »

AOL CEO Tim Armstrong…

VZ

Verizon

$49.75

-0.06 (-0.12%)

YHOO

Yahoo

$40.20

0.13 (0.32%)

03/08/13
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TUWOY

Tullow Oil

$2.06

0.109 (5.58%)

18:46
12/05/16
12/05
18:46
12/05/16
18:46
Downgrade
Tullow Oil rating change  »

Tullow Oil downgraded to…

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03/06/13
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GBNK

Guaranty Bancorp

$22.15

0.75 (3.50%)

18:43
12/05/16
12/05
18:43
12/05/16
18:43
Hot Stocks
Breaking Hot Stocks news story on Guaranty Bancorp »

Castle Creek raises stake…

03/08/13
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ATKR

Atkore

$20.48

-0.18 (-0.87%)

18:41
12/05/16
12/05
18:41
12/05/16
18:41
Syndicate
Atkore files to sell 8M shares of common stock for holders »

The offering is being…

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UTX

United Technologies

$107.42

-0.8 (-0.74%)

18:38
12/05/16
12/05
18:38
12/05/16
18:38
Hot Stocks
United Technologies CEO: No quid pro quo on taxes in Carrier deal with Trump »

Says Carrier agreement…

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IPDN

Professional Diversity Network

$9.75

-0.01 (-0.10%)

18:37
12/05/16
12/05
18:37
12/05/16
18:37
Hot Stocks
Breaking Hot Stocks news story on Professional Diversity Network »

North Star cuts passive…

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DHXM

DHX Media

$5.05

-0.36 (-6.65%)

18:33
12/05/16
12/05
18:33
12/05/16
18:33
Hot Stocks
Breaking Hot Stocks news story on DHX Media »

Luxor Capital cuts…

03/08/13
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TPHS

Trinity Place

$10.02

0.08 (0.80%)

18:24
12/05/16
12/05
18:24
12/05/16
18:24
Hot Stocks
Trinity Place Holdings, Pacolet Milliken acquire Brooklyn building for $68.8M »

Trinity Place Holdings…

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SU

Suncor

$32.46

0.23 (0.71%)

18:07
12/05/16
12/05
18:07
12/05/16
18:07
Hot Stocks
Suncor Energy resolves C$1.3B tax dispute with Canada Revenue Agency »

Suncor Energy reports…

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XLRN

Acceleron

$34.90

-1.39 (-3.83%)

, CELG

Celgene

$116.56

-1.07 (-0.91%)

18:07
12/05/16
12/05
18:07
12/05/16
18:07
Hot Stocks
Acceleron, Celgene report Phase 2 data on luspatercept in beta-thalassemia »

Acceleron Pharma (XLRN)…

XLRN

Acceleron

$34.90

-1.39 (-3.83%)

CELG

Celgene

$116.56

-1.07 (-0.91%)

03/08/13
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SNSS

Sunesis

$4.02

0.12 (3.08%)

17:54
12/05/16
12/05
17:54
12/05/16
17:54
Hot Stocks
Sunesis says new VALOR trial data show 'compelling durable survival outcomes' »

Sunesis Pharmaceuticals…

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