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EGLT

Egalet

$6.73

-0.09 (-1.32%)

13:55
12/01/16
12/01
13:55
12/01/16
13:55

Egalet submits FDA application to expand label for Oxaydo

Egalet announced it has submitted to the U.S. FDA a supplemental new drug application for Oxaydo tablets C-II to support an abuse-deterrent label claim for the intravenous route of abuse. Oxaydo is an immediate-release oral formulation of oxycodone HCl indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. The sNDA includes Category 1 in-vitro data that demonstrate Oxaydo resists extraction of oxycodone and, based on its gelling properties, is more difficult to draw into a syringe. "There are currently no abuse-deterrent, IR opioids on the market today," the company noted. "With the issue of abuse of immediate-release opioids receiving more attention recently, we look forward to working with the FDA," chief medical officer Jeffrey Dayno commented. The sNDA will be a standard FDA review which carries a six-month review timeline.

EGLT Egalet
$6.73

-0.09 (-1.32%)

05/11/16
JANY
05/11/16
NO CHANGE
JANY
Neutral
Egalet elimination of Chief Commercial Officer puzzling, says Janney Capital
Janney Capital analyst Ken Trbovich said the "lackluster" quarterly revenues reported by Egalet "ought to concern those looking for a major ramp" from its existing products, though he continues to think the stock's prospects are tied to the potential approval and launch of Arymo, not its Oxaydo and Sprix products. Additionally, the removal of its "once highly touted" Chief Commercial Officer is "puzzling," given her expertise in the pain space and the impending launch of Arymo, Trbovich tells investors. The analyst raised his estimates for Egalet, citing its lower expenses, but keeps a Neutral rating on the shares.
08/04/16
08/04/16
NO CHANGE

On The Fly: After Hours Movers
UP AFTER EARNINGS: Pacific Biosciences (PACB), up 17%... MasTec (MTZ), up 9.6%... Aratana Therapeutics (PETX), up 9.2%... Lion's Gate (LGF), up 6.4%... Priceline (PCLN), up 5.7%... Ubiquiti (UBNT), up 5.5%... MercadoLibre (MELI), up 4.1%... Organovo (ONVO), up 3.9%... Kraft Heinz (KHC), up 3.3%... EOG Resources (EOG), up 2.8%... Monster Beverage (MNST), up 1.2%... TASER (TASR), up 1.2%... Take-Two (TTWO), up 0.9%... Activision Blizzard (ATVI), up 1%... BioMarin (BMRN), up 0.4%. ALSO HIGHER: Egalet (EGLT), up 31.2% after the company announced that an FDA advisory committee recommended approval of its ARYMO ER drug... Rackspace (RAX), up 17.6% after the Wall Street Journal reported that the company was near a takeover deal with a private equity buyer... Osiris (OSIR), up 8.5% after it said that the manuscript from its prospective trial using Grafix was published. DOWN AFTER EARNINGS: Hortonworks (HDP), down 26.2%... PDL BioPharma (PDLI), down 17.5%... FireEye (FEYE), down 15.8%... Sierra Wireless (SWIR), down 15.6%... Aquinox (AQXP), down 14.7%... Zynga (ZNGA), down 9.4%... Universal Display (OLED), down 8.2%... Weight Watchers (WTW), down 7.6%... Zillow Group (Z, ZG), down 5.5%... Arista Networks (ANET), down 4.5%... Noodles & Company (NDLS), down 4.3%... Merrimack (MACK), down 1.7%... Bankrate (RATE), down 1.7%.
09/13/16
GABE
09/13/16
INITIATION
Target $9.5
GABE
Buy
Egalet initiated with a Buy at Gabelli
Gabelli initiated Egalet with a Buy and a $9.50 price target.
10/26/16
JANY
10/26/16
NO CHANGE
JANY
Neutral
Egalet's Arymo faces increased risk from Morphabond, says Janney Capital
Janney Capital analyst Ken Trbovich noted that privately held Inspirion Delivery Sciences entered into a collaboration agreement that gives Daiichi Sankyo rights to commercialize Morphabond, which means that product may be commercialized before Egalet's Arymo, which is "tied up in a delay of unknown duration" with the FDA. Morphabond being the first abuse-deterrent, extended-release morphine-based product to launch without a blackbox warning for co-ingestion with alcohol will make it more difficult for Egalet to gain traction with Arymo, said Trbovich, who keeps a Neutral rating on the shares.

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FOX

21st Century Fox

$29.86

-0.07 (-0.23%)

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21st Century Fox

$30.54

-0.02 (-0.07%)

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FOX

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$29.86

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FOXA

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$30.54

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BX

Blackstone

$30.84

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TRCO

Tribune Media

$36.56

-0.28 (-0.76%)

SBGI

Sinclair Broadcast

$39.45

-0.9 (-2.23%)

TSLA

Tesla

$314.07

5.44 (1.76%)

TWTR

Twitter

$16.48

-0.13 (-0.78%)

CMCSA

Comcast

$39.19

-0.4 (-1.01%)

CMCSK

Comcast

DIS

Disney

$115.60

-0.24 (-0.21%)

CAT

Caterpillar

$102.26

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NEE

NextEra Energy

$133.56

0.04 (0.03%)

EPC

Edgewell Personal Care

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COH

Coach

$39.39

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LITE

Lumentum

$42.75

-1.05 (-2.40%)

OCLR

Oclaro

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0.08 (1.01%)

ESRX

Express Scripts

$61.34

-0.06 (-0.10%)

CMG

Chipotle

$474.47

-7.53 (-1.56%)

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AWI

Armstrong World

$46.75

-0.75 (-1.58%)

, L

Loews

$46.62

-0.71 (-1.50%)

20:25
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AWI

Armstrong World

$46.75

-0.75 (-1.58%)

L

Loews

$46.62

-0.71 (-1.50%)

ENSG

Ensign Group

$17.95

-1.17 (-6.12%)

DO

Diamond Offshore

$14.42

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DISH

Dish

$64.44

-0.56 (-0.86%)

BSFT

BroadSoft

$38.40

-0.05 (-0.13%)

CNA

CNA Financial

$45.26

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CMS

CMS Energy

$45.40

-0.09 (-0.20%)

BWP

Boardwalk Pipeline

$18.14

-0.02 (-0.11%)

CAH

Cardinal Health

$72.59

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TOSBF

Toshiba, also use TOSYY

$2.03

0.06 (3.05%)

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Toshiba, also use TOSBF

$12.14

0.25 (2.10%)

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TOSBF

Toshiba, also use TOSYY

$2.03

0.06 (3.05%)

TOSYY

Toshiba, also use TOSBF

$12.14

0.25 (2.10%)

WDC

Western Digital

$89.07

3.36 (3.92%)

KKR

KKR

$18.98

0.25 (1.33%)

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TRCO

Tribune Media

$36.56

-0.28 (-0.76%)

, FOX

21st Century Fox

$29.86

-0.07 (-0.23%)

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TRCO

Tribune Media

$36.56

-0.28 (-0.76%)

FOX

21st Century Fox

$29.86

-0.07 (-0.23%)

FOXA

21st Century Fox

$30.54

-0.02 (-0.07%)

BX

Blackstone

$30.84

-0.13 (-0.42%)

SBGI

Sinclair Broadcast

$39.45

-0.9 (-2.23%)

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HESM

Hess Midstream Partners

$25.58

0.08 (0.31%)

19:39
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SFTBF

SoftBank

$75.98

0.38 (0.50%)

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SoftBank poised to invest more than $1.5B in Paytm, WSJ says »

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NVO

Novo Nordisk

$38.68

-0.1 (-0.26%)

19:12
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Novo Nordisk settles probe of drug marketing practices, Bloomberg says »

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BDRBF

Bombardier

$1.56

-0.0722 (-4.42%)

, BA

Boeing

$184.83

1.61 (0.88%)

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BDRBF

Bombardier

$1.56

-0.0722 (-4.42%)

BA

Boeing

$184.83

1.61 (0.88%)

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AMZN

Amazon.com

$924.99

6.61 (0.72%)

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TSLA

Tesla

$314.07

5.44 (1.76%)

18:28
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SolarCity to curtail door-to-door sales tactic, Reuters says »

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DIS

Disney

$115.60

-0.24 (-0.21%)

, CMCSA

Comcast

$39.19

-0.4 (-1.01%)

18:16
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Hulu likely to unveil cable bundle at end of May, NY Post says »

Hulu will likely unveil…

DIS

Disney

$115.60

-0.24 (-0.21%)

CMCSA

Comcast

$39.19

-0.4 (-1.01%)

CMCSK

Comcast

FOX

21st Century Fox

$29.86

-0.07 (-0.23%)

FOXA

21st Century Fox

$30.54

-0.02 (-0.07%)

TWX

Time Warner

$99.27

-0.63 (-0.63%)

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TCEHY

Tencent

$31.35

-0.11 (-0.35%)

, FB

Facebook

$150.25

2.55 (1.73%)

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Tencent plans to launch VR headset later this year, FT says »

Tencent (TCEHY) is…

TCEHY

Tencent

$31.35

-0.11 (-0.35%)

FB

Facebook

$150.25

2.55 (1.73%)

SSNLF

Samsung

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CYH

Community Health

$8.61

0.18 (2.14%)

, HCA

HCA Holdings

$84.21

0.77 (0.92%)

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CYH

Community Health

$8.61

0.18 (2.14%)

HCA

HCA Holdings

$84.21

0.77 (0.92%)

LPNT

LifePoint

$62.15

1.4 (2.30%)

THC

Tenet

$15.67

0.2 (1.29%)

UHS

Universal Health

$120.76

2.55 (2.16%)

UNH

UnitedHealth

$174.88

0.25 (0.14%)

KND

Kindred Healthcare

$9.60

0.25 (2.67%)

VTR

Ventas

$64.01

-0.11 (-0.17%)

AET

Aetna

$135.07

1.09 (0.81%)

ANTM

Anthem

$177.89

-0.41 (-0.23%)

CI

Cigna

$156.37

0.16 (0.10%)

HUM

Humana

$221.98

3.31 (1.51%)

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DAL

Delta Air Lines

$45.44

-0.3 (-0.66%)

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Delta pilot returns to duty after possibly striking brawling woman, NYT says »

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TSLA

Tesla

$314.07

5.44 (1.76%)

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TSLA

Tesla

$314.07

5.44 (1.76%)

17:03
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Tesla CEO releases teaser image of semi truck, Fortune says »

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CMCSA

Comcast

$39.19

-0.4 (-1.01%)

, CMCSK

Comcast

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CMCSA

Comcast

$39.19

-0.4 (-1.01%)

CMCSK

Comcast

LGF.A

Lionsgate

$26.17

-0.11 (-0.42%)

LGF.B

Lionsgate

$23.85

-0.15 (-0.63%)

FOX

21st Century Fox

$29.86

-0.07 (-0.23%)

FOXA

21st Century Fox

$30.54

-0.02 (-0.07%)

DIS

Disney

$115.60

-0.24 (-0.21%)

SNE

Sony

$34.52

0.8 (2.37%)

TWX

Time Warner

$99.27

-0.63 (-0.63%)

VIA

Viacom

$44.60

-0.8 (-1.76%)

VIAB

Viacom

$42.56

-0.75 (-1.73%)

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ELLO

Ellomay Capital

$8.05

0.0019 (0.02%)

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GLPG

Galapagos NV

$86.86

0.87 (1.01%)

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SO

Southern Company

$49.80

-0.27 (-0.54%)

, TOSBF

Toshiba, also use TOSYY

$2.03

0.06 (3.05%)

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SO

Southern Company

$49.80

-0.27 (-0.54%)

TOSBF

Toshiba, also use TOSYY

$2.03

0.06 (3.05%)

TOSYY

Toshiba, also use TOSBF

$12.14

0.25 (2.10%)

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CG

Carlyle Group

$17.70

0.2 (1.14%)

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Sequa completes recapitalization with participation from Carlyle Group »

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IBM

IBM

$160.29

-0.03 (-0.02%)

14:07
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IBM says granted patent for drone package transfer »

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GRAM

Grana y Montero

$3.37

0.07 (2.12%)

14:05
04/30/17
04/30
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14:05
Hot Stocks
Grana y Montero completes sale of PRINSUR stake for $25M »

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KO

Coca-Cola

$43.15

0.14 (0.33%)

13:49
04/30/17
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13:49
Hot Stocks
Coca-Cola Bottling UNITED says closes Georgia transaction with Coca-Cola »

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