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MRK

Merck

$79.26

-0.58 (-0.73%)

06:49
02/20/19
02/20
06:49
02/20/19
06:49

Merck: FDA grants priority review for sBLA for KEYTRUDA

Merck announced that the U.S. FDA has accepted and granted priority review for a new supplemental Biologics License Application for KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell lung cancer whose disease has progressed after two or more lines of prior therapy. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials. The FDA has set a Prescription Drug User Fee Act, or target action, date of June 17.

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MRK Merck
$79.26

-0.58 (-0.73%)

01/23/19
01/23/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Tesla (TSLA) downgraded to Underperform from Sector Perform at RBC Capital with analyst Joseph Spak saying the company's more "tactful messaging" conveys downward pressure to growth expectations and also sees the "realities" of Tesla becoming a volume player highlighting its "challenges to scale and deliver high volume at high ASPs/margins." 2. Lowe's (LOW) downgraded to Hold from Buy at Loop Capital with analyst Laura Champine saying she thinks she was previously too optimistic on Lowe's likely margin progression. 3. Williams-Sonoma (WSM) downgraded to Underweight from Equal Weight at Morgan Stanley with analyst Simeon Gutman saying he believes top and bottom-line pressures will intensify in 2019. 4. Merck (MRK) downgraded to Market Perform from Outperform at BMO Capital with analyst Alex Arfaei citing the company's over-dependence on Keytruda, the Street's high expectations, and his views on upcoming competitor trials combining for a more balanced risk-reward on Merck. 5. Pfizer (PFE) and Mylan (MYL) were downgraded to Neutral from Buy at UBS. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
02/01/19
PIPR
02/01/19
NO CHANGE
Target $3
PIPR
Overweight
Piper says OncoSec's TAVO resensitizing anti-PD-1 progressers 'impressive'
After OncoSec (ONCS) reported updated data for the registrational KEYNOTE-695 study evaluating TAVO plus Merck's (MRK) Keytruda, Piper Jaffray analyst Edward Tenthoff noted that TAVO's ORR improved and called the fact that TAVO resensitized anti-PD-1 progressers "impressive." He reiterates an Overweight and $3 price target on OncoSec shares.
02/05/19
BOFA
02/05/19
NO CHANGE
BOFA
Merck added to US 1 List, Allergan removed at BofA/Merrill
02/14/19
02/14/19
NO CHANGE

Merck initiating three Phase 3 trials with Keytruda for prostate cancer
Merck (announced the presentation of interim data from the Phase 1b/2 KEYNOTE-365 umbrella trial investigating Keytruda, Merck's anti-PD-1 therapy, in combination with various agents for the treatment of patients with metastatic castration-resistant prostate cancer. These early findings show anti-tumor activity across three cohorts of the study, which investigated Keytruda in combination with Lynparza for Cohort A, docetaxel and prednisone for Cohort B, and enzalutamide for Cohort C - with a safety profile consistent with each therapy alone. These results are being presented at the 2019 Genitourinary Cancers Symposium in San Francisco. Based on the findings, Merck is initiating three new pivotal Phase 3 trials with Keytruda in combination with Lynparza, docetaxel and prednisone and enzalutamide. With the initiation of KEYLYNK-010, KEYNOTE-921 and KEYNOTE-641, Merck now has the only program to evaluate overall survival as a co-primary endpoint across three Phase 3 trials.

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LEN

Lennar

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WHR

Whirlpool

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3.4 (2.29%)

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TELL

Tellurian

$8.33

-0.1 (-1.19%)

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Initiation
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NEXT

NextDecade

$6.30

-0.1 (-1.56%)

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LINX

Linx S.A.

$7.74

0.22 (2.93%)

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Recommendations
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Conference/Events
Morgan Stanley steel analyst to hold an analyst/industry conference call »

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GIS

General Mills

$55.03

0.48 (0.88%)

20:25
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Earnings
Notable companies reporting before tomorrow's open »

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ROAD

Construction Partners

$14.39

-0.42 (-2.84%)

20:10
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20:10
Syndicate
Construction Partners 5M share Secondary priced at $14.25 »

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NVST

Envista

$0.00

(0.00%)

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Syndicate
Envista 26.77M share IPO priced at $22.00 »

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INVH

Invitation Homes

$28.49

0.31 (1.10%)

19:51
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Syndicate
Invitation Homes 44M share Spot Secondary priced at $28.25 »

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AMC

AMC Entertainment

$11.46

-0.46 (-3.86%)

, NCMI

National CineMedia

$8.35

0.25 (3.09%)

19:49
09/17/19
09/17
19:49
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19:49
Hot Stocks
AMC Entertainment corrects 'inaccurate' statement by National CineMedia »

AMC Entertainment (AMC)…

AMC

AMC Entertainment

$11.46

-0.46 (-3.86%)

NCMI

National CineMedia

$8.35

0.25 (3.09%)

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  • 09

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BA

Boeing

$384.61

5.74 (1.52%)

19:01
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Hot Stocks
House panel invites Boeing CEO to testify on 737 MAX »

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O

Realty Income

$75.76

1.81 (2.45%)

18:56
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Hot Stocks
Realty Income raises monthly cash dividend to 22.7c per share from 22.65c »

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NLNK

NewLink Genetics

$1.90

-0.03 (-1.55%)

, CDW

CDW

$113.91

0.94 (0.83%)

18:54
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Hot Stocks
Fly Intel: After Hours Movers »

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NLNK

NewLink Genetics

$1.90

-0.03 (-1.55%)

CDW

CDW

$113.91

0.94 (0.83%)

TELL

Tellurian

$8.33

-0.1 (-1.19%)

NEXT

NextDecade

$6.30

-0.1 (-1.56%)

FDX

FedEx

$173.53

-0.14 (-0.08%)

XPO

XPO Logistics

$73.83

-0.76 (-1.02%)

CHWY

Chewy

$30.20

-0.2 (-0.66%)

ADBE

Adobe

$284.59

1.54 (0.54%)

IOTS

Adesto Technologies

$10.63

-0.66 (-5.85%)

PTCT

PTC Therapeutics

$43.26

0.27 (0.63%)

TBIO

Translate Bio

$11.01

0.405 (3.82%)

ACAD

Acadia

$42.60

-1.45 (-3.29%)

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YUMA

Yuma Energy

$5.08

-0.05 (-0.97%)

18:51
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Yuma Energy enters forbearance agreement with lender YE Investment »

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ADBE

Adobe

$284.59

1.54 (0.54%)

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Adobe CEO: We experienced growth across all of our segments »

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ARAY

Accuray

$3.09

-0.03 (-0.96%)

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FBK

FB Financial

$38.33

-0.36 (-0.93%)

18:29
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FB Financial acquires FNB Financial »

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GM

General Motors

$38.28

1.07 (2.88%)

18:28
09/17/19
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18:28
Periodicals
GM stops paying health insurance costs for union workers on strike, Reuters says »

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TOT

Total

$52.85

0.08 (0.15%)

18:25
09/17/19
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Periodicals
Total CEO says Saudi oil facility strikes will have consequences, Reuters says »

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SMMF

Summit Financial Group

$25.96

-0.29 (-1.10%)

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STLD

Steel Dynamics

$30.93

-0.89 (-2.80%)

18:01
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Earnings
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FDX

FedEx

$173.53

-0.14 (-0.08%)

18:00
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Hot Stocks
Breaking Hot Stocks news story on FedEx »

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FDX

FedEx

$173.53

-0.14 (-0.08%)

17:59
09/17/19
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FedEx says new FY20 EPS forecast assumes no further weakening in economic growth »

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BTI

British American Tobacco

$36.84

0.825 (2.29%)

, PM

Philip Morris

$71.98

-0.54 (-0.74%)

17:57
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17:57
General News
NY State implements first-in-nation ban on flavored e-cigarettes »

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BTI

British American Tobacco

$36.84

0.825 (2.29%)

PM

Philip Morris

$71.98

-0.54 (-0.74%)

MO

Altria Group

$41.31

-0.1 (-0.24%)

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