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MRK

Merck

$62.77

0.11 (0.18%)

16:08
10/09/16
10/09
16:08
10/09/16
16:08

Merck reports 18-month data from KEYNOTE-010, other Keytruda data sets

Merck announced that Keytruda demonstrated superiority in overall survival at 18 months compared to standard of care chemotherapy -- docetaxel -- in patients with metastatic non-small cell lung cancer previously treated with platinum-containing chemotherapy whose tumors expressed PD-L1, as well as patients with high levels of PD-L1 expression. The data, from the phase 2/3 KEYNOTE-010 trial, will be presented at the ESMO 2016 Congress. In addition, an analysis of patient-reported health-related quality of life outcomes showed more patients treated with Keytruda reported positive outcomes compared to patients treated with chemotherapy. Separately, researchers also presented an analysis of PD-L1 prevalence across three separate studies, including KEYNOTE-010. Overall, 66 percent of patients with metastatic NSCLC expressed any level of PD-L1, and 28 percent expressed high levels of PD-L1. Specifically, the new data from KEYNOTE-010 included six months of additional follow-up, with a median follow-up of 19.2 months, and showed superior outcomes of OS, PFS, and ORR with Keytruda compared to docetaxel in patients with PD-L1 expression as well as high levels of PD-L1 expression -- with consistency of outcomes across Keytruda doses. In patients with PD-L1 expression, OS at 18 months was 37 percent with Keytruda 2 mg/kg, 43 percent with Keytruda 10 mg/kg, and 24 percent with docetaxel. Among all patients, median OS was 10.5 months with Keytruda 2 mg/kg, 13.6 months with Keytruda 10 mg/kg, and 8.6 months with docetaxel. ORR was 19 percent with Keytruda 2 mg/kg, 20 percent with Keytruda 10 mg/kg and 10 percent with docetaxel. Responses to Keytruda continued to be durable; among patients with any level of PD-L1 expression who responded to treatment, 60 percent on each of the Keytruda treatment arms were alive, progression-free, and had not received additional therapy for their disease, compared to 15 percent in the docetaxel treatment arm. In patients with high levels of PD-L1 expression, OS at 18 months was 46 percent with Keytruda 2 mg/kg, 52 percent with Keytruda 10 mg/kg, and 24 percent with docetaxel. In this group, median OS was 15.8 months with Keytruda 2 mg/kg, 18.8 months with Keytruda 10 mg/kg, and 8.2 months with docetaxel. ORR was 29 percent with Keytruda 2 mg/kg, 32 percent with Keytruda 10 mg/kg, and nine percent with docetaxel. Responses to Keytruda continued to be durable; among patients with high levels of PD-L1 expression who responded to treatment, 68 and 63 percent on the Keytruda 2 mg/kg and 10 mg/kg treatment arms, respectively, were alive, progression-free, and had not received additional therapy for their disease, compared to 15 percent in the docetaxel treatment arm. Treatment-related adverse events remained lower with Keytruda compared to docetaxel. Also reported at the ESMO 2016 Congress were health-related quality of life outcomes from the KEYNOTE-010 trial. Overall, from baseline to the 12-week assessment, patients treated with Keytruda reported numeric improvements, some of which were significant, in HRQoL and prolonged time to deterioration of lung cancer symptoms compared with docetaxel. Additionally, results from a third NSCLC abstract at the ESMO 2016 Congress explored, for the first time, the prevalence of PD-L1 in patients screened across multiple studies. The analysis assessed 4,784 patients with NSCLC who had tumors evaluable for PD-L1 expression and were screened for eligibility in three registrational studies of Keytruda -- KEYNOTE-001, KEYNOTE-010, and KEYNOTE-024. Based on this pooled analysis, 66 percent of patients across all three trials were determined to express PD-L1 and 28 percent were determined to have high levels of PD-L1 expression. These findings were similar across demographic and disease characteristics examined, including prior lines of therapy, age, tumor source, and histology.

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    Nov

MRK Merck
$62.77

0.11 (0.18%)

09/21/16
FBCO
09/21/16
UPGRADE
Target $41
FBCO
Outperform
Clovis upgraded to Outperform from Neutral at Credit Suisse
Credit Suisse analyst Kennen MacKay upgraded Clovis Oncology (CLVS) to Outperform and raised his price target for the shares to $41 from $19. Clovis closed yesterday up 13%, or $3.92, to $34.83. The potential for a takeover "outweighs concerns surrounding patent life, limited experience in platinum resistant/refractory patients, and PARPi competition," MacKay tells investors in a research note. Clovis could be worth $35-$41 per share in a buyout on operational synergies, and $52-$55 per share with leveraged tax benefits, MacKay estimates. He points out that Eli Lilly (Lill)y, Merck (MRK), Japan's Takeda and others have expressed interest in acquiring U.S. oncology companies.
09/27/16
PIPR
09/27/16
NO CHANGE
Target $62
PIPR
Neutral
Bristol-Myers price target lowered to $62 from $65 at Piper Jaffray
Piper Jaffray analyst Richard Purkiss lowered his price target for Bristol-Myers Squibb (BMY) to $62 saying he sees the company ceding Opdivo's early-mover advantage in lung cancer to competitors. The analyst expects to see details from Roche's (RHHBY) positive OAK trial of Tecentriq vs. docetaxel in non-small cell lung cancer at the upcoming ESMO meeting. Purkiss also expects to see details from Merck's (MRK) positive KEYNOTE-024 trial of Keytruda. The analyst lowered his post-2016 Opdivo forecasts and reiterates a Neutral rating on Bristol shares.
10/03/16
LEER
10/03/16
NO CHANGE
LEER
Market Perform
AASLD abstracts hint at potential competitive threat to Gilead HCV, says Leerink
Leerink analyst Geoffrey Porges says abstracts for the American Association for the Study of Liver Diseases, or AASLD, meeting revealed very limited efficacy information about the new Hepatitis C regimens for Gilead (GILD), Merck (MRK) and AbbVie (ABBV). Nonetheless, the analyst believes the abstracts hint at the potential competitive threat to Gilead's HCV dominance. While the new 12-week HCV regimens may compete on price, the forthcoming 8-week regimens put the most pressure on Gilead's market share, Porges argues. He reiterates a Market Perform rating on Gilead's shares.
10/07/16
LEER
10/07/16
NO CHANGE
LEER
Outperform
Incyte Epacadostat Phase 1 Melanoma data maturing well, says Leerink
Leerink analyst Michael Schmidt says the data from ECHO-202 Phase 1 study evaluating the combination of Incyte's (INCY) IDO1 inhibitor epacadostat with Merck's (MRK) Keytruda confirms the previously published results and appears to be maturing well. The analyst reiterates an Outperform rating on Incyte's shares, saying Jakafi remains a compelling long-term growth driver for the company, expectations for baricitinib are still moderate, and its maturing oncology pipeline of 14 molecules including epacadostat represents a long-term value driver.

TODAY'S FREE FLY STORIES

CELC

Celcuity

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BSTI

BEST Inc

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GIS

General Mills

$55.38

-1.05 (-1.86%)

20:25
09/19/17
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20:25
Earnings
Notable companies reporting before tomorrow's open »

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PCRX

Pacira

$35.70

-0.6 (-1.65%)

20:00
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09/19
20:00
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20:00
Recommendations
Pacira analyst commentary at BMO Capital »

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    Sep

AVEVF

Aveva

19:56
09/19/17
09/19
19:56
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19:56
Upgrade
Aveva rating change at Goldman Sachs »

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ZLAB

Zai Lab

18:58
09/19/17
09/19
18:58
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18:58
Syndicate
Zai Lab announces upsizing of U.S. IPO of American depositary shares »

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  • 20

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OHI

Omega Healthcare

$32.53

-0.12 (-0.37%)

18:30
09/19/17
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Omega Healthcare provides hurricane update »

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F

Ford

$11.72

0.09 (0.77%)

18:30
09/19/17
09/19
18:30
09/19/17
18:30
Periodicals
Ford to slash production at five North American assembly plants, Reuters says »

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FDX

FedEx

$216.00

0.92 (0.43%)

18:26
09/19/17
09/19
18:26
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18:26
Hot Stocks
FedEx says without cyberattack FY18 guidance would not have changed »

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EE

El Paso Electric

$54.85

0.05 (0.09%)

18:25
09/19/17
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18:25
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18:25
Hot Stocks
El Paso Electric announces City of El Paso approved settlement terms »

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BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

18:17
09/19/17
09/19
18:17
09/19/17
18:17
Hot Stocks
Bed Bath & Beyond says biggest component in drop of FY17 EPS view is operations »

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  • 19

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CPRT

Copart

$32.54

-0.32 (-0.97%)

18:11
09/19/17
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18:11
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18:11
Earnings
Copart reports Q4 EPS 30c, consensus 29c »

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  • 20

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STLD

Steel Dynamics

$33.83

0.03 (0.09%)

18:04
09/19/17
09/19
18:04
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18:04
Earnings
Steel Dynamics sees Q3 adjusted EPS 63c-67c, consensus 70c »

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XBKS

Xenith Bankshares

$29.96

0.42 (1.42%)

17:58
09/19/17
09/19
17:58
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17:58
Hot Stocks
Treasury exits stake in Xenith Bankshares »

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BMY

Bristol-Myers

$62.93

0.23 (0.37%)

17:54
09/19/17
09/19
17:54
09/19/17
17:54
Periodicals
Breaking Periodicals news story on Bristol-Myers »

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BBBY

Bed Bath & Beyond

17:54
09/19/17
09/19
17:54
09/19/17
17:54
Hot Stocks
Breaking Hot Stocks news story on Bed Bath & Beyond »

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  • 19

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DESP

Despegar.com

17:52
09/19/17
09/19
17:52
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17:52
Syndicate
Despegar.com 12.7M share IPO priced at $26.00 »

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  • 20

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WAC

Walter Investment

$0.65

0.186 (40.09%)

17:50
09/19/17
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17:50
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Walter Investment says Barclays to increase financing available »

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CBAY

CymaBay

17:49
09/19/17
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Initiation
CymaBay initiated at Cantor »

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BBBY

Bed Bath & Beyond

17:46
09/19/17
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Hot Stocks
Bed Bath & Beyond sees net drop in Bed Bath & Beyond stores in FY17 »

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  • 19

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EVH

Evolent Health

$15.65

-0.8 (-4.86%)

17:45
09/19/17
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17:45
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17:45
Initiation
Evolent Health initiated at KeyBanc »

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  • 25

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BPL

Buckeye Partners

$56.33

0.64 (1.15%)

17:44
09/19/17
09/19
17:44
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17:44
Syndicate
Buckeye Partners announces $210M in limited partnership unit sales »

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RL

Ralph Lauren

$91.03

0.87 (0.96%)

17:43
09/19/17
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17:43
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17:43
Initiation
Ralph Lauren initiated at Barclays »

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PVH

PVH Corp.

$127.47

-0.54 (-0.42%)

17:43
09/19/17
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17:43
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17:43
Initiation
PVH Corp. initiated at Barclays »

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  • 19

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GEMP

Gemphire Therapeutics

$9.65

0.54 (5.93%)

, ORIG

Ocean Rig UDW

$0.16

-0.0083 (-4.90%)

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On The Fly: After Hours Movers »

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GEMP

Gemphire Therapeutics

$9.65

0.54 (5.93%)

ORIG

Ocean Rig UDW

$0.16

-0.0083 (-4.90%)

IOVA

Iovance Biotherapeutics

$8.55

0.3 (3.64%)

BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

FDX

FedEx

$216.00

0.92 (0.43%)

ADBE

Adobe

$156.60

0.83 (0.53%)

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