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SIGA

Siga Technologies

$6.85

0.61 (9.78%)

15:49
07/13/18
07/13
15:49
07/13/18
15:49

FDA approves Siga Technologies' TPOXX treatment for smallpox

SIGA Technologies announced that the U.S. Food and Drug Administration has approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak. TPOXX, a small-molecule antiviral treatment for smallpox, is the first therapy specifically approved for this indication. On May 1, 2018, the FDA's Antimicrobial Drugs Advisory Committee voted unanimously, 17 to 0, that the benefits of TPOXX outweigh its risks. Concurrent with the approval, FDA granted SIGA's request for a Priority Review Voucher. A PRV is a voucher that may be used to obtain an accelerated FDA review of a future SIGA product, or sold to a third party, and this is the first PRV awarded under the Material Threat Countermeasure PRV program enacted by the 2016 21st Century Cures Act. In addition, FDA approved a seven-year expiry for TPOXX. Under SIGA's existing contract with the Biomedical Advanced Research and Development Authority (BARDA), the company will ask BARDA to exercise an option for a $50 million payment to the company based on this extended shelf-life determination. The exercise of this option is at the sole discretion of BARDA. With the approval, SIGA is entitled to a $41 million hold back payment under the existing contract with BARDA, provided that BARDA confirms that there is no difference between the approved product and the courses of TPOXX that have already been delivered to the Strategic National Stockpile. FDA approval is based on data from 12 clinical trials of oral TPOXX in over 700 healthy human volunteers, which showed no drug-related serious adverse events. Four pivotal trials in non-human primates (NHPs) and two pivotal trials in rabbits demonstrated that TPOXX significantly reduced both mortality and viral load in NHP infected with monkeypox virus (MPXV) and in rabbits infected with rabbitpox virus. The results of these studies were published in the July 5, 2018 issue of the New England Journal of Medicine.

  • 08

    Aug

TODAY'S FREE FLY STORIES

SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$280.34

-0.7 (-0.25%)

15:04
07/19/18
07/19
15:04
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15:04
Periodicals
Congress set to enact major changes to foreign investment reviews, WSJ says »

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S&P 500

$0.00

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SPDR S&P 500 ETF Trust

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ISRG

Intuitive Surgical

$525.06

-2.61 (-0.49%)

15:04
07/19/18
07/19
15:04
07/19/18
15:04
Options
Intuitive Surgical options imply 6.4% move in share price post-earnings, above median historical move »

Pre-earnings options…

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WSM

Williams-Sonoma

$62.96

1.63 (2.66%)

15:00
07/19/18
07/19
15:00
07/19/18
15:00
Options
Upside call buyers in Williams Sonoma as shares rally »

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14:50
07/19/18
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14:50
Conference/Events
Morgan Stanley economist/strategist to hold analyst/industry conference call »

Chief Economist Zentner,…

MRK

Merck

$62.68

-0.26 (-0.41%)

14:50
07/19/18
07/19
14:50
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14:50
Hot Stocks
Merck commits to not increase average net prices by more than inflation annually »

Merck noted that in 2017,…

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MSFT

Microsoft

$104.59

-0.49 (-0.47%)

14:49
07/19/18
07/19
14:49
07/19/18
14:49
Options
Microsoft options imply 4.8% move in share price post-earnings, above median historical move »

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ETP

Energy Transfer Partners

$20.14

0.74 (3.81%)

14:45
07/19/18
07/19
14:45
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14:45
Options
Energy Transfer Partners call volume above normal and directionally bullish »

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14:45
07/19/18
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General news
Canada CPI preview »

Canada CPI preview: CPI,…

14:45
07/19/18
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14:45
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14:45
General news
Canada retail sales preview »

Canada retail sales…

COF

Capital One

$95.79

-1.3 (-1.34%)

, SYF

Synchrony

$33.47

0.06 (0.18%)

14:41
07/19/18
07/19
14:41
07/19/18
14:41
Periodicals
Head of U.S. card partnerships leaving Capital One, Bloomberg says »

Jimmy Cannon, executive…

COF

Capital One

$95.79

-1.3 (-1.34%)

SYF

Synchrony

$33.47

0.06 (0.18%)

WMT

Walmart

$88.10

0.01 (0.01%)

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14:35
07/19/18
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14:35
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14:35
General news
FX Action: USD-JPY »

FX Action: USD-JPY found…

HQY

HealthEquity

$81.82

0.31 (0.38%)

14:32
07/19/18
07/19
14:32
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14:32
Recommendations
HealthEquity analyst commentary  »

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GE

General Electric

$13.80

0.05 (0.36%)

, HON

Honeywell

$147.50

-1.65 (-1.11%)

14:32
07/19/18
07/19
14:32
07/19/18
14:32
Earnings
Notable companies reporting before tomorrow's openGentex »

Notable companies…

GE

General Electric

$13.80

0.05 (0.36%)

HON

Honeywell

$147.50

-1.65 (-1.11%)

SLB

Schlumberger

$66.83

-0.24 (-0.36%)

BHGE

Baker Hughes

$32.10

-0.44 (-1.35%)

STT

State Street

$92.52

-2.82 (-2.96%)

VFC

VF Corp.

$89.22

1.01 (1.15%)

STI

SunTrust

$69.16

-0.69 (-0.99%)

SWK

Stanley Black & Decker

$139.18

0.91 (0.66%)

RF

Regions Financial

$17.75

-0.3 (-1.66%)

CFG

Citizens Financial

$40.62

-0.405 (-0.99%)

KSU

Kansas City Southern

$107.87

1.32 (1.24%)

GNTX

Gentex

$23.63

-0.195 (-0.82%)

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SKX

Skechers

$33.23

0.6 (1.84%)

14:30
07/19/18
07/19
14:30
07/19/18
14:30
Options
Notable spread in Skechers ahead of earnings »

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  • 19

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ISRG

Intuitive Surgical

$525.36

-2.31 (-0.44%)

14:29
07/19/18
07/19
14:29
07/19/18
14:29
Earnings
On The Fly: What to watch in Intuitive Surgical earnings report »

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TSLA

Tesla

$321.44

-2.57 (-0.79%)

, PCRFY

Panasonic

$0.00

(0.00%)

14:28
07/19/18
07/19
14:28
07/19/18
14:28
Periodicals
Panasonic suspends supplier of cobalt used in Tesla batteries, Reuters reports »

Panasonic (PCRFY), the…

TSLA

Tesla

$321.44

-2.57 (-0.79%)

PCRFY

Panasonic

$0.00

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MSFT

Microsoft

$104.45

-0.63 (-0.60%)

, ISRG

Intuitive Surgical

$525.36

-2.31 (-0.44%)

14:27
07/19/18
07/19
14:27
07/19/18
14:27
Earnings
Notable companies reporting after market close »

Notable companies…

MSFT

Microsoft

$104.45

-0.63 (-0.60%)

ISRG

Intuitive Surgical

$525.36

-2.31 (-0.44%)

COF

Capital One

$95.69

-1.4 (-1.44%)

CTAS

Cintas

$193.16

0.62 (0.32%)

SWKS

Skyworks

$102.68

0.63 (0.62%)

ETFC

E-Trade

$61.35

-1.79 (-2.84%)

PBCT

People's United

$18.30

-0.04 (-0.22%)

SKX

Skechers

$33.25

0.62 (1.90%)

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ESV

Ensco

$7.02

-0.055 (-0.78%)

14:25
07/19/18
07/19
14:25
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14:25
Options
Ensco call volume above normal and directionally bullish »

Bullish option flow…

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  • 26

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

14:17
07/19/18
07/19
14:17
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14:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

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$NYE

NYSE Market Internals

$0.00

(0.00%)

14:16
07/19/18
07/19
14:16
07/19/18
14:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

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SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$280.59

-0.45 (-0.16%)

14:15
07/19/18
07/19
14:15
07/19/18
14:15
General news
White House says Trump not interfering with Fed policy decisions »

The White House told…

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S&P 500

$0.00

(0.00%)

SPY

SPDR S&P 500 ETF Trust

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-0.45 (-0.16%)

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MSFT

Microsoft

$104.73

-0.35 (-0.33%)

14:10
07/19/18
07/19
14:10
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14:10
Periodicals
Microsoft found hacking attempts against congressional candidates, Politico says »

Microsoft discovered and…

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GTLS

Chart Industries

$76.20

8.23 (12.11%)

14:10
07/19/18
07/19
14:10
07/19/18
14:10
Recommendations
Chart Industries analyst commentary  »

Chart Industries Q2…

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MSFT

Microsoft

$104.70

-0.38 (-0.36%)

, AMZN

Amazon.com

$1,828.13

-14.23 (-0.77%)

14:05
07/19/18
07/19
14:05
07/19/18
14:05
Earnings
On The Fly: What to watch in Microsoft earnings report »

Microsoft (MSFT) is…

MSFT

Microsoft

$104.70

-0.38 (-0.36%)

AMZN

Amazon.com

$1,828.13

-14.23 (-0.77%)

GOOGL

Alphabet Class A

$1,201.64

-11 (-0.91%)

GOOG

Alphabet

$1,188.06

-7.75 (-0.65%)

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HMNY

Helios and Matheson

$0.11

-0.0066 (-5.90%)

14:01
07/19/18
07/19
14:01
07/19/18
14:01
Periodicals
MoviePass competitor Sinemia now offering $3.99/month plans, Fortune says »

MoviePass competitor…

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