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VVUS

VIVUS

$0.75

0.0163 (2.22%)

07:37
07/10/18
07/10
07:37
07/10/18
07:37

VIVUS announces 'positive' results from Phase 1 clinical trial of VI-0106

VIVUS announced positive preliminary results from a Phase 1 clinical study evaluating the pharmacokinetic profile of its VI-0106 in healthy volunteers. VIVUS is developing VI-0106, a proprietary soft capsule formulation of tacrolimus for the treatment of pulmonary arterial hypertension, a degenerative disease that makes it difficult for the heart to pump blood through the lungs to be oxygenated and may ultimately lead to heart failure. The U.S. Food and Drug Administration approved tacrolimus in 1994 for use in lowering the risk of organ rejection in patients undergoing kidney transplant, and the drug is currently indicated for use in additional organ transplant settings and to treat atopic dermatitis. Tacrolimus has been shown to increase signaling through the bone morphogenetic protein receptor 2 pathway, which is down-regulated in PAH patients. The single-center, UK-based Phase 1 PK study was conducted in two parts. Sixteen healthy volunteers were enrolled in Part 1 and each patient sequentially received single doses of three different tacrolimus prototype regimens administered at least 10 days apart. An interim analysis was conducted following the third dosing period to select a formulation prototype with the most desirable PK profile. Three subsequent periods assessed the selected formulation at different doses, or under different fed/fasted conditions. The second part of the study evaluated steady-state PK parameters in 12 healthy volunteers receiving daily doses of the selected prototype formulation. VIVUS is developing VI-0106 under the FDA's 505(B)(2) regulatory pathway, which will allow the Company to leverage the FDA's finding of safety and effectiveness for tacrolimus as well as a significant body of previously published tacrolimus safety and efficacy data. This is expected to reduce the time and cost to develop VI-0106 as a potential breakthrough therapy for the treatment of PAH. In September 2017, results of a university-run Phase 2a clinical study of tacrolimus in patients with PAH were published in the European Respiratory Journal. Study results demonstrate the safety of tacrolimus in patients with PAH. The currently approved formulation of VI-0106 tacrolimus was also provided for compassionate use in three class 3 or 4 PAH patients. The compassionate use demonstrated dramatically reduced rates of hospitalizations and functional class improvements were observed. VIVUS believes that VI-0106 could become an important new treatment option for PAH patients and intends to request both Fast Track and Breakthrough Therapy Designation from the FDA for VI-0106 in this indication.

  • 07

    Sep

TODAY'S FREE FLY STORIES

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General news
China's GDP slowed to a 6.5% y/y growth pace in Q3 »

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NI

NiSource

$25.25

0.22 (0.88%)

21:12
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PNW

Pinnacle West

$83.48

-0.235 (-0.28%)

21:04
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Pinnacle West rating change at Goldman Sachs »

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NVS

Novartis

$86.24

0.9 (1.05%)

20:26
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20:26
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Novartis granted orphan status for melanoma treatment »

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PG

Procter & Gamble

$80.31

-0.8628 (-1.06%)

, HON

Honeywell

$155.22

-2.73 (-1.73%)

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

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PG

Procter & Gamble

$80.31

-0.8628 (-1.06%)

HON

Honeywell

$155.22

-2.73 (-1.73%)

SLB

Schlumberger

$58.43

-0.81 (-1.37%)

VFC

VF Corp.

$87.07

-2.22 (-2.49%)

STT

State Street

$79.62

-2.5 (-3.04%)

STI

SunTrust

$61.46

-0.94 (-1.51%)

SYF

Synchrony

$29.63

-0.45 (-1.50%)

CFG

Citizens Financial

$34.92

-0.96 (-2.68%)

KSU

Kansas City Southern

$102.68

-1.31 (-1.26%)

IPG

Interpublic Group

$22.48

0.28 (1.26%)

EEFT

Euronet

$112.64

-2.96 (-2.56%)

MAN

Manpower

$78.38

-1.09 (-1.37%)

GNTX

Gentex

$18.62

-0.32 (-1.69%)

CLF

Cleveland-Cliffs

$11.47

-0.37 (-3.13%)

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CP

Canadian Pacific

$199.27

-6.68 (-3.24%)

20:24
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Canadian Pacific rating change at National Bank »

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  • 18

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DWDP

DowDuPont

$58.60

-0.98 (-1.64%)

19:57
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Hot Stocks
DowDuPont clarifies the charge is the result of previously reported conditions »

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VLP

Valero Energy Partners

$39.94

0.5 (1.27%)

19:35
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Valero Energy Partners rating change at RBC Capital »

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  • 25

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IVZ

Invesco

$21.26

0.32 (1.53%)

19:33
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Invesco rating change at Credit Suisse »

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  • 18

    Oct

LOGC

LogicBio Therapeutics

$0.00

(0.00%)

19:31
10/18/18
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Syndicate
LogicBio Therapeutics 7M share IPO priced at $10.00 »

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MDSO

Medidata

$70.91

1.54 (2.22%)

19:07
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19:07
Recommendations
Medidata analyst commentary at JPMorgan »

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  • 18

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TSLA

Tesla

$263.85

-8.09 (-2.97%)

18:58
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Periodicals
Tesla rolls out new Model 3 with 'mid-range' battery pack, Electrek reports »

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SKX

Skechers

$26.05

-0.64 (-2.40%)

, PYPL

PayPal

$77.50

-2.61 (-3.26%)

18:51
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Fly Intel: After Hours Movers »

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Skechers

$26.05

-0.64 (-2.40%)

PYPL

PayPal

$77.50

-2.61 (-3.26%)

CE

Celanese

$97.01

-2.76 (-2.77%)

CP

Canadian Pacific

$199.27

-6.68 (-3.24%)

ISRG

Intuitive Surgical

$522.41

-20.44 (-3.77%)

AXP

American Express

$102.86

-1.53 (-1.47%)

ETFC

E-Trade

$48.89

-1.68 (-3.32%)

VLP

Valero Energy Partners

$39.94

0.5 (1.27%)

VLO

Valero

$103.31

-0.36 (-0.35%)

FBC

Flagstar Bancorp

$29.26

-0.33 (-1.12%)

OZK

Bank OZK

$34.85

-1.57 (-4.31%)

LLNW

Limelight Networks

$5.07

0.12 (2.42%)

TEAM

Atlassian

$81.96

-1.67 (-2.00%)

AIG

AIG

$48.62

-0.99 (-2.00%)

SREV

ServiceSource

$2.60

-0.08 (-2.99%)

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X

U.S. Steel

$27.91

-0.27 (-0.96%)

, AKS

AK Steel

$4.69

-0.115 (-2.39%)

18:47
10/18/18
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Periodicals
U.S. requests WTO panel to examine metals tariffs retaliation, Reuters says »

The U.S. has asked the…

X

U.S. Steel

$27.91

-0.27 (-0.96%)

AKS

AK Steel

$4.69

-0.115 (-2.39%)

NUE

Nucor

$58.26

-0.85 (-1.44%)

STLD

Steel Dynamics

$41.32

0.77 (1.90%)

AA

Alcoa

$38.85

2.14 (5.83%)

CENX

Century Aluminum

$9.91

-0.23 (-2.27%)

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  • 02

    Nov

RLH

Red Lion Hotels

$12.62

-0.42 (-3.22%)

18:43
10/18/18
10/18
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18:43
Hot Stocks
Red Lion Hotels CFO Douglas Ludwig resigns due to personal health reasons »

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  • 15

    Nov

IDA

IDACORP

$96.78

0.035 (0.04%)

18:30
10/18/18
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18:30
Hot Stocks
IDACORP declares quarterly dividend of 63c per share »

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KRYS

Krystal Biotech

$20.70

-0.59 (-2.77%)

18:08
10/18/18
10/18
18:08
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18:08
Syndicate
Krystal Biotech 3M share Secondary priced at $20.00 per share »

Cowen, William Blair and…

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  • 18

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FBC

Flagstar Bancorp

$29.26

-0.33 (-1.12%)

, SVU

Supervalu

$32.49

0.02 (0.06%)

18:05
10/18/18
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18:05
Hot Stocks
S&P announces changes to S&P SmallCap 600 index »

S&P Dow Jones Indices…

FBC

Flagstar Bancorp

$29.26

-0.33 (-1.12%)

SVU

Supervalu

$32.49

0.02 (0.06%)

UNFI

United Natural Foods

$26.94

0.2 (0.75%)

TTGT

TechTarget

$19.53

-0.35 (-1.76%)

PERY

Perry Ellis

$27.48

0.02 (0.07%)

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SXT

Sensient

$76.67

-1.15 (-1.48%)

18:02
10/18/18
10/18
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18:02
Hot Stocks
Sensient raises quarterly dividend to 36c from 33c per share »

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  • 19

    Oct

DWDP

DowDuPont

$58.60

-0.98 (-1.64%)

18:02
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10/18
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Hot Stocks
DowDuPont says Sept. quarter results won't be impacted by $4.5B goodwill charge »

On October 18, 2018, E.…

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NOG

Northern Oil and Gas

$3.54

-0.13 (-3.54%)

17:55
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17:55
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Northern Oil and Gas sees Q4 production 58% greater than Q2 »

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  • 13

    Nov

SHPG

Shire

$176.90

-0.4 (-0.23%)

17:47
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Hot Stocks
FDA advisory committee recommends Shire's Prucalopride for CIC »

Shire announced that the…

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  • 18

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    Dec

ACN

Accenture

$156.20

-2.76 (-1.74%)

, T

AT&T

$32.50

-0.06 (-0.18%)

17:37
10/18/18
10/18
17:37
10/18/18
17:37
Hot Stocks
CACI, IBM, Northrop Grumman and more compete for orders on $37.4B Army contract »

Accenture Federal…

ACN

Accenture

$156.20

-2.76 (-1.74%)

T

AT&T

$32.50

-0.06 (-0.18%)

CACI

CACI

$181.34

-2.07 (-1.13%)

HII

Huntington Ingalls

$233.27

0.15 (0.06%)

CMTL

Comtech

$32.05

-0.95 (-2.88%)

IBM

IBM

$130.52

-3.53 (-2.63%)

JEC

Jacobs Engineering

$73.01

-0.89 (-1.20%)

KFRC

Kforce

$35.15

-0.49 (-1.37%)

LLL

L3 Technologies

$218.17

-1.965 (-0.89%)

LDOS

Leidos

$66.72

-0.97 (-1.43%)

NOC

Northrop Grumman

$308.21

-1.04 (-0.34%)

RTN

Raytheon

$191.62

-1.48 (-0.77%)

KEYW

KEYW

$8.31

-0.27 (-3.15%)

VSEC

VSE Corp.

$30.75

-1.13 (-3.54%)

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UBSFY

Ubisoft

$0.00

(0.00%)

, BBY

Best Buy

$72.63

-1.2 (-1.63%)

17:31
10/18/18
10/18
17:31
10/18/18
17:31
Periodicals
Certain boxes of new Ubisoft game from Best Buy didn't include game, Kotaku says »

A number of Best Buy…

UBSFY

Ubisoft

$0.00

(0.00%)

BBY

Best Buy

$72.63

-1.2 (-1.63%)

NTDOY

Nintendo

$0.00

(0.00%)

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  • 18

    Oct

AXP

American Express

$102.86

-1.53 (-1.47%)

17:28
10/18/18
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17:28
Hot Stocks
American Express says revenue growth 'directly' linked to company decisions »

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