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ARGS

Argos Therapeutics

$1.10

-0.02 (-1.79%)

08:13
04/19/18
04/19
08:13
04/19/18
08:13

Argos Therapeutics to discontinue Phase 3 ADAPT trial of Rocapuldencel-T

Argos Therapeutics reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of newly diagnosed metastatic renal cell carcinoma. Based on these results, the company has decided to discontinue the trial. As previously reported, a total of 462 patients with previously untreated advanced or metastatic renal cell carcinoma were enrolled in the ADAPT trial and randomized 2:1 between combination treatment with Rocapuldencel-T and sunitinib vs. sunitinib monotherapy after undergoing cytoreductive nephrectomy. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration providing for four co-primary endpoints focused on various measures of survival. Based upon review of the interim data, the Company does not believe that it would achieve these endpoints if the trial were to be continued. After consulting with the principal investigators of the trial, the Company has therefore decided to discontinue the trial and has informed the FDA of its decision. The most recent interim analysis was conducted after 51 new events had occurred since the time of the February 2017 interim analysis. Median overall survival for the intent-to-treat patient population, one of the four co-primary endpoints, was estimated using the Kaplan-Meier method. The estimated median overall survival for the combination arm was 28.2 months compared to 31.2 months for the control arm. The hazard ratio was 1.10. The two other co-primary endpoints that were evaluated at this time, including overall survival for the patients who remained alive at the time of the February 2017 interim analysis and overall survival for all patients for whom at least 12 months of follow-up was available, also did not demonstrate a favorable result. A fourth endpoint, five-year survival, was not evaluated because there was insufficient data at this time to perform this analysis.

TODAY'S FREE FLY STORIES

ROST

Ross Stores

$82.95

0.35 (0.42%)

08:52
05/25/18
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Technical Take: Ross Stores falls after earnings »

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GPS

Gap

$32.97

1 (3.13%)

, FL

Foot Locker

$46.38

1.35 (3.00%)

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On The Fly: Pre-market Movers »

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GPS

Gap

$32.97

1 (3.13%)

FL

Foot Locker

$46.38

1.35 (3.00%)

DECK

Deckers Brands

$103.63

0.8 (0.78%)

HIBB

Hibbett Sports

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0.6 (2.12%)

AMRN

Amarin

$3.04

0.04 (1.33%)

TEVA

Teva

$21.64

0.485 (2.29%)

BMRN

BioMarin

$88.30

-0.2 (-0.23%)

ZOES

Zoe's Kitchen

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-0.41 (-2.75%)

EGHT

8x8, Inc.

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0.35 (1.62%)

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-0.2 (-0.17%)

CBB

Cincinnati Bell

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-0.225 (-1.39%)

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LOMA

Loma Negra

$11.52

-1.47 (-11.32%)

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Loma Negra

$11.52

-1.47 (-11.32%)

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SPY

SPDR S&P 500 ETF Trust

$272.87

-0.5 (-0.18%)

, SPX

S&P 500

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08:49
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General news
Trump says 'time will tell' after 'warm and productive' North Korean statement »

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SPY

SPDR S&P 500 ETF Trust

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-0.5 (-0.18%)

SPX

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HLF

Herbalife Nutrition

$53.85

-0.14 (-0.26%)

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FCAU

Fiat Chrysler

$22.26

-0.205 (-0.91%)

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Conference/Events
Federal Reserve Chairman Powell participates in a panel discussion »

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NOK

Nokia

$6.09

-0.01 (-0.16%)

, AAOI

Applied Optoelectronics

$33.91

0.24 (0.71%)

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Options
Largest borrow rate increases among liquid names »

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NOK

Nokia

$6.09

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AAOI

Applied Optoelectronics

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0.24 (0.71%)

MDXG

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GERN

Geron

$4.81

0.14 (3.00%)

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U.S. durable goods orders fell 1.7% in April »

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TIF

Tiffany

$126.44

0.3 (0.24%)

08:34
05/25/18
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08:34
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Tiffany analyst commentary  »

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DECK

Deckers Brands

$103.63

0.8 (0.78%)

08:34
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Technical Analysis
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USNA

USANA

$116.75

-2.85 (-2.38%)

08:34
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WB

Weibo

$102.36

-1.08 (-1.04%)

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HWC

Hancock Whitney Corporation

$51.60

-0.2 (-0.39%)

, BBRG

Bravo Brio Restaurant

$4.05

(0.00%)

08:30
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Options
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HWC

Hancock Whitney Corporation

$51.60

-0.2 (-0.39%)

BBRG

Bravo Brio Restaurant

$4.05

(0.00%)

HBHC

Symbol changed to HWC

$51.60

-0.2 (-0.39%)

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08:30
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Fed Chairman Powell will make an appearance »

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SPLK

Splunk

$116.35

-0.2 (-0.17%)

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FL

Foot Locker

$46.38

1.35 (3.00%)

08:27
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Technical Take: Foot Locker sharply higher after earning beat, outlook »

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WAL

Western Alliance

$61.53

-0.305 (-0.49%)

, FCB

FCB Financial

$61.60

0.2 (0.33%)

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Western Alliance, FCB Financial analyst commentary  »

Western Alliance unlikely…

WAL

Western Alliance

$61.53

-0.305 (-0.49%)

FCB

FCB Financial

$61.60

0.2 (0.33%)

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LH

LabCorp

$175.31

-0.27 (-0.15%)

, DGX

Quest Diagnostics

$100.89

-0.34 (-0.34%)

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LabCorp, Quest Diagnostics, UnitedHealth, Aetna analyst commentary  »

UnitedHealth news…

LH

LabCorp

$175.31

-0.27 (-0.15%)

DGX

Quest Diagnostics

$100.89

-0.34 (-0.34%)

UNH

UnitedHealth

$242.73

-1.48 (-0.61%)

AET

Aetna

$177.05

-0.31 (-0.17%)

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ZOES

Zoe's Kitchen

$14.48

-0.41 (-2.75%)

08:21
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05/25
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08:21
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Zoe's Kitchen rating change  »

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$DJT

DJ Transportation Average

$0.00

(0.00%)

08:21
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DJ Transportation Average: Pivot points »

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$DJU

DJ Utility Average

$0.00

(0.00%)

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DJ Utility Average: Pivot points »

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GPS

Gap

$32.97

1 (3.13%)

, LULU

Lululemon

$106.37

1.13 (1.07%)

08:20
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08:20
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Gap, Lululemon analyst commentary  »

Gap pullback a buying…

GPS

Gap

$32.97

1 (3.13%)

LULU

Lululemon

$106.37

1.13 (1.07%)

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