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BLPH

Bellerophon

$2.24

-0.14 (-5.88%)

08:55
08/07/18
08/07
08:55
08/07/18
08:55

Bellerophon says DMC recommends stopping Phase 3 INOvation-1 study of INOpulse

Bellerophon Therapeutics announced that the Data Monitoring Committee has completed its pre-specified interim analysis from the first 75 enrolled subjects completing 16-weeks of treatment in the Phase 3 INOvation-1 study evaluating INOpulse for the treatment of pulmonary arterial hypertension.The DMC has recommended that the trial be stopped for futility. INOpulse was well-tolerated and there were no safety concerns that led the DMC to recommend concluding the trial. The data showed improvement in pulmonary vascular resistance, however, the DMC deemed the overall change in 6 minute walk distance, the primary endpoint of the trial, insufficient to support the continuation of the study. As previously agreed upon with the U.S. Food and Drug Administration, the pre-specified interim analysis was conducted by the DMC after half of the planned subjects completed 16-weeks of blinded treatment. The DMC considered four potential recommendations relative to its review of the data: stopping the trial early for efficacy, continuing to enroll the study as planned, increasing the targeted enrollment size if the original design was slightly underpowered, and stopping the study for futility or safety concerns. "While we are disappointed in the overall efficacy results of this study, we are encouraged by the positive data in hemodynamics and pleased with the safety and tolerability profile of INOpulse. Over the next few weeks, we intend to further analyze the full data set available to us from this interim analysis in order to determine the next steps in our PAH program. On behalf of everyone at Bellerophon, I would like to thank all of the patients and physicians who participated in the INOvation-1 study," said CEO Fabian Tenenbaum. "Based on the results of our Phase 2 studies in pulmonary hypertension associated with interstitial lung disease and pulmonary hypertension associated with chronic obstructive pulmonary disease, we remain positive regarding the potential of our other INOpulse programs. Unlike PAH, patients with PH-ILD and PH-COPD have underlying lung disease for which systemic vasodilators have been ineffective and there are currently no approved therapies. Our ongoing Phase 2b trial in PH-ILD is progressing well, with top-line results expected around the end of 2018. PH-ILD is a significant unmet medical need which we believe represents a substantial potential market opportunity." Bellerophon has sufficient resources to support its currently planned activities into the first half of 2019.

TODAY'S FREE FLY STORIES

11:30
06/25/19
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General news
Treasury announced a $75 B batch of auctions for Thursday »

Treasury announced a $75…

ACER

Acer Therapeutics

$4.31

-14.86 (-77.52%)

11:25
06/25/19
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11:25
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Acer Therapeutics rating change  »

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CLDR

Cloudera

$5.53

0.005 (0.09%)

11:25
06/25/19
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11:25
Options
Cloudera call volume above normal and directionally bullish »

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CODI

Compass Diversified

$19.00

0.345 (1.85%)

11:25
06/25/19
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11:25
Conference/Events
Compass Diversified to host investor & analyst meeting »

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UMC

UMC

$2.14

-0.01 (-0.47%)

11:23
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11:23
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UMC rating change  »

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ACER

Acer Therapeutics

$4.30

-14.87 (-77.57%)

11:18
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Acer Therapeutics rating change  »

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IBKR

Interactive Brokers

$52.52

0.07 (0.13%)

, ETFC

E-Trade

$44.03

-0.54 (-1.21%)

11:17
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Conference/Events
Sandler O'Neill financial analyst to hold an analyst/industry conference call »

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Interactive Brokers

$52.52

0.07 (0.13%)

ETFC

E-Trade

$44.03

-0.54 (-1.21%)

SCHW

Charles Schwab

$39.09

-0.06 (-0.15%)

AMTD

TD Ameritrade

$47.90

-0.19 (-0.40%)

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

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Technical Analysis
NASDAQ market internals summary »

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$NYE

NYSE Market Internals

$0.00

(0.00%)

11:16
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NYSE market internals summary »

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DLTR

Dollar Tree

$110.51

-2.21 (-1.96%)

11:15
06/25/19
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11:15
Options
Dollar Tree put volume heavy and directionally bearish »

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PBR

Petrobras

$16.24

-0.34 (-2.05%)

11:05
06/25/19
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11:05
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11:05
Options
Petrobras call volume above normal and directionally bullish »

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  • 26

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RDS.B

Royal Dutch Shell

$66.83

0.04 (0.06%)

11:02
06/25/19
06/25
11:02
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11:02
Conference/Events
Royal Dutch Shell management to meet with JPMorgan »

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MSADY

MS&AD Insurance

$0.00

(0.00%)

11:00
06/25/19
06/25
11:00
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11:00
Conference/Events
MS&AD Insurance management to meet with JPMorgan »

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DNKN

Dunkin' Brands

$79.51

-1.5 (-1.85%)

, GRUB

GrubHub

$75.00

2.95 (4.09%)

11:00
06/25/19
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11:00
06/25/19
11:00
On The Fly
Grubhub upgrade, Brighthouse downgrades among today's top analyst actions »

Check out today's top…

DNKN

Dunkin' Brands

$79.51

-1.5 (-1.85%)

GRUB

GrubHub

$75.00

2.95 (4.09%)

BHF

Brighthouse Financial

$34.28

-3.82 (-10.03%)

MSFT

Microsoft

$135.30

-2.5 (-1.81%)

AMZN

Amazon.com

$1,887.85

-25.58 (-1.34%)

SHAK

Shake Shack

$67.38

0.7 (1.05%)

CMG

Chipotle

$735.05

10.91 (1.51%)

SBUX

Starbucks

$84.19

0.54 (0.65%)

MCD

McDonald's

$204.99

1.07 (0.52%)

YUM

Yum! Brands

$110.44

-0.18 (-0.16%)

WEN

Wendy's

$19.21

0.06 (0.31%)

JACK

Jack in the Box

$81.61

-1.22 (-1.47%)

TIF

Tiffany

$90.50

-1.36 (-1.48%)

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    Nov

11:00
06/25/19
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11:00
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General news
The U.S. consumer confidence drop to a 2-year low »

The U.S. consumer…

HR

Healthcare Realty Trust

$32.43

0.23 (0.71%)

10:59
06/25/19
06/25
10:59
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10:59
Conference/Events
Healthcare Realty Trust management to meet with JPMorgan »

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UN

Unilever; also tag UL

$61.77

-0.11 (-0.18%)

, UL

Unilever; also tag UN

$62.81

-0.11 (-0.17%)

10:59
06/25/19
06/25
10:59
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10:59
Periodicals
Unilever to close Nevada plant, impacting about 300 jobs, Reuters reports »

Unilever plans to close…

UN

Unilever; also tag UL

$61.77

-0.11 (-0.18%)

UL

Unilever; also tag UN

$62.81

-0.11 (-0.17%)

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BCKIF

Babcock

$0.00

(0.00%)

10:57
06/25/19
06/25
10:57
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10:57
Conference/Events
Babcock management to meet with JPMorgan »

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ALKS

Alkermes

$21.78

0.19 (0.88%)

10:55
06/25/19
06/25
10:55
06/25/19
10:55
Conference/Events
Alkermes management to meet with JPMorgan »

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  • 25

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HRL

Hormel Foods

$41.11

-1.04 (-2.47%)

10:55
06/25/19
06/25
10:55
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10:55
Options
Hormel Foods put volume heavy and directionally bearish »

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10:55
06/25/19
06/25
10:55
06/25/19
10:55
General news
Treasury 2-year auction outlook: today's auction will be a test »

Treasury 2-year auction…

EEFT

Euronet

$161.01

-1.51 (-0.93%)

10:55
06/25/19
06/25
10:55
06/25/19
10:55
Conference/Events
Euronet management to meet with William Blair »

Group Luncheon Meeting to…

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    Nov

UBER

Uber

$43.35

0.35 (0.81%)

10:52
06/25/19
06/25
10:52
06/25/19
10:52
Initiation
Uber initiated at Daiwa »

Uber initiated with a…

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  • 09

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10:45
06/25/19
06/25
10:45
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10:45
General news
Breaking General news story  »

8-Week Bill Announcement…

10:45
06/25/19
06/25
10:45
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10:45
General news
Breaking General news story  »

4-Week Bill Announcement…

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