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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.

TODAY'S FREE FLY STORIES

BMY

Bristol-Myers

$62.28

0.45 (0.73%)

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EXEL

Exelixis

$28.00

0.14 (0.50%)

, RHHBY

Roche

$30.69

0.18 (0.59%)

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EXEL

Exelixis

$28.00

0.14 (0.50%)

RHHBY

Roche

$30.69

0.18 (0.59%)

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ARRY

Array BioPharma

$13.14

0.26 (2.02%)

15:17
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Array BioPharma updates results from BEACON Phase 3 trial »

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SO

Southern Company

$44.44

-0.46 (-1.02%)

15:13
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Southern Company accelerates restoration efforts in Puerto Rico »

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TECK

Teck Resources

$29.43

0.19 (0.65%)

15:10
01/20/18
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Teck Resources announces Elkview incident »

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TWTR

Twitter

$23.66

-0.38 (-1.58%)

14:03
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01/20
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14:03
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Twitter begins notifying users exposed to Russian propaganda during elections »

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SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

, SPX

S&P 500

13:58
01/20/18
01/20
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Government shuts down on anniversary of Trump presidency, Reuters reports »

President's Trump…

SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

SPX

S&P 500

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FB

Facebook

$181.29

1.49 (0.83%)

, NYT

New York Times

$21.90

1.7 (8.42%)

13:48
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Periodicals
NY Times stock jumps after Facebook's announcement, Recode reports »

Facebook (FB) CEO Mark…

FB

Facebook

$181.29

1.49 (0.83%)

NYT

New York Times

$21.90

1.7 (8.42%)

NWSA

News Corp.

$17.22

0.21 (1.23%)

FOXA

21st Century Fox

$36.65

0.47 (1.30%)

03/08/13
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WMT

Walmart

$104.59

0.29 (0.28%)

13:36
01/20/18
01/20
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13:36
Periodicals
Still time to shop Walmart shares as company makes changes, Barron's says »

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AAPL

Apple

$178.46

-0.8 (-0.45%)

, NFLX

Netflix

$220.46

0.13 (0.06%)

08:59
01/20/18
01/20
08:59
01/20/18
08:59
Periodicals
Netflix among likely candidates for an Apple purchase, Barron's says »

Especially for tech…

AAPL

Apple

$178.46

-0.8 (-0.45%)

NFLX

Netflix

$220.46

0.13 (0.06%)

03/08/13
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BA

Boeing

$337.73

-2.43 (-0.71%)

08:50
01/20/18
01/20
08:50
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08:50
Periodicals
Boeing not a sell just yet, Barron's says »

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AAPL

Apple

$178.46

-0.8 (-0.45%)

, EADSY

Airbus

$28.43

0.755 (2.73%)

08:24
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Hot Stocks
Week in review: How Trump's policies moved stocks »

Catch up on the top…

AAPL

Apple

$178.46

-0.8 (-0.45%)

EADSY

Airbus

$28.43

0.755 (2.73%)

BA

Boeing

$337.73

-2.43 (-0.71%)

VZ

Verizon

$51.91

0.36 (0.70%)

NYT

New York Times

$21.90

1.7 (8.42%)

TWX

Time Warner

$93.36

0.39 (0.42%)

DIS

Disney

$110.59

0.17 (0.15%)

TIME

Time Inc.

$18.55

0.05 (0.27%)

AMZN

Amazon.com

$1,294.58

1.26 (0.10%)

BAC

Bank of America

$31.72

0.24 (0.76%)

GS

Goldman Sachs

$256.12

5.15 (2.05%)

BK

BNY Mellon

$56.61

1.26 (2.28%)

WLKP

Westlake Chemical Partners

$24.45

-0.1 (-0.41%)

MON

Monsanto

$120.66

1.8 (1.51%)

DLTR

Dollar Tree

$114.73

1.83 (1.62%)

CE

Celanese

$112.96

1.93 (1.74%)

LYB

LyondellBasell

$119.92

3.03 (2.59%)

TSE

Trinseo

$79.45

2.2 (2.85%)

EYE

National Vision

$43.13

1.12 (2.67%)

ETFC

E-Trade

$54.28

0.63 (1.17%)

LPLA

LPL Financial

$59.03

0.53 (0.91%)

AMTD

TD Ameritrade

$55.17

0.21 (0.38%)

SCHW

Charles Schwab

$55.48

0.15 (0.27%)

ADS

Alliance Data

$261.82

5.88 (2.30%)

FISV

Fiserv

$138.11

0.17 (0.12%)

FLT

FleetCor

$206.65

3.4 (1.67%)

HAWK

Blackhawk

$45.25

0.1 (0.22%)

MTZ

MasTec

$53.30

1.25 (2.40%)

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CME

CME Group

$154.28

2.07 (1.36%)

, GS

Goldman Sachs

$256.12

5.15 (2.05%)

04:55
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Conference/Events
American Bar Association to hold annual meeting »

Derivatives & Futures…

CME

CME Group

$154.28

2.07 (1.36%)

GS

Goldman Sachs

$256.12

5.15 (2.05%)

BP

BP

$42.40

-0.5 (-1.17%)

C

Citi

$78.30

0.91 (1.18%)

BAC

Bank of America

$31.72

0.24 (0.76%)

CS

Credit Suisse

$19.06

0.13 (0.69%)

CRL

Charles River

$107.89

1.22 (1.14%)

MS

Morgan Stanley

$57.46

1.62 (2.90%)

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AMGN

Amgen

$189.28

1.69 (0.90%)

, BAYRY

Bayer

$32.05

0.235 (0.74%)

04:55
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Conference/Events
American Society of Clinical Oncology to hold a symposium »

2018 ASCO…

AMGN

Amgen

$189.28

1.69 (0.90%)

BAYRY

Bayer

$32.05

0.235 (0.74%)

BLRX

BioLineRx

$1.09

-0.02 (-1.80%)

BMY

Bristol-Myers

$62.28

0.45 (0.73%)

CELG

Celgene

$102.65

0.93 (0.91%)

DNA

Bought by RHHBY

ESALY

Eisai

$56.88

0.115 (0.20%)

EXEL

Exelixis

$28.00

0.14 (0.50%)

HALO

Halozyme

$17.98

0.13 (0.73%)

INCY

Incyte

$93.16

1.24 (1.35%)

IPSEY

Ipsen

$34.65

0.75 (2.21%)

LXRX

Lexicon

$10.44

0.2 (1.95%)

MGNX

MacroGenics

$19.19

0.3 (1.59%)

MRK

Merck

$61.28

0.15 (0.25%)

NVS

Novartis

$86.94

0.53 (0.61%)

SNY

Sanofi

$44.60

0.09 (0.20%)

ONCY

Oncolytics

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WLFC

Willis Lease

$26.66

0.05 (0.19%)

18:59
01/19/18
01/19
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18:59
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Willis Lease announces $1,000 bonus for employees »

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DPS

Dr Pepper Snapple

$96.35

1.03 (1.08%)

18:13
01/19/18
01/19
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Hot Stocks
Dr Pepper to become official sponsor of esports team TSM »

Dr Pepper announced it is…

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RCII

Rent-A-Center

$11.70

0.09 (0.78%)

17:53
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Vintage Capital in standstill pact with Rent-A-Center »

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AR

Antero Resources

$18.74

-0.59 (-3.05%)

17:44
01/19/18
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17:44
Recommendations
Antero Resources analyst commentary at MUFG »

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T

AT&T

$37.21

0.06 (0.16%)

, TWX

Time Warner

$93.36

0.39 (0.42%)

17:44
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AT&T requesting docs from companies in Time Warner deal hearing, Reuters says »

AT&T (T) is…

T

AT&T

$37.21

0.06 (0.16%)

TWX

Time Warner

$93.36

0.39 (0.42%)

VZ

Verizon

$51.91

0.36 (0.70%)

CMCSA

Comcast

$42.50

0.65 (1.55%)

CMCSK

Comcast

DISH

Dish

$45.26

0.1 (0.22%)

CHTR

Charter

$366.05

0.8 (0.22%)

DIS

Disney

$110.59

0.17 (0.15%)

VIA

Viacom

$39.20

-0.5 (-1.26%)

VIAB

Viacom

$33.36

-0.59 (-1.74%)

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GRPN

Groupon

$5.57

0.46 (9.00%)

17:44
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Groupon announces Chief Product Officer Jay Sullivan resigns »

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CELG

Celgene

$102.65

0.93 (0.91%)

17:41
01/19/18
01/19
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17:41
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Celgene's Abraxane exceeds primary endpoint target in pancreatic cancer trial »

Celgene announced primary…

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VALU

Value Line

$19.60

0.3 (1.55%)

17:40
01/19/18
01/19
17:40
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17:40
Hot Stocks
Value Line reaffirms $3M stock repurchase program »

The Board of Directors…

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VALU

Value Line

$19.60

0.3 (1.55%)

17:39
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Value Line declares special dividend of 20c per share »

Payable on March 9 to…

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ZEAL

Zealand Pharma

$15.05

-0.78 (-4.93%)

17:34
01/19/18
01/19
17:34
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17:34
Hot Stocks
Zealand Pharma: FDA approves IND for Phase 3 trials of dasiglucagon in CHI »

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GNMSF

Genmab

$190.75

2.75 (1.46%)

, JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

17:29
01/19/18
01/19
17:29
01/19/18
17:29
Hot Stocks
Genmab says FDA grants priority review for daratumumab »

Genmab (GNMSF) announced…

GNMSF

Genmab

$190.75

2.75 (1.46%)

JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

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