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EGLT

Egalet

$7.52

0.11 (1.48%)

18:06
10/13/16
10/13
18:06
10/13/16
18:06

Egalet says FDA will not meet PDUFA goal data for ARYMO ER

Egalet Corporation announced that the U.S. Food and Drug Administration will not meet the previously announced October 14 prescription drug user fee act date for ARYMO ER. "Today we were informed that the FDA has identified no particular issue with our application for ARYMO ER and that the Agency is working on the product label," said Bob Radie, president and chief executive officer. "The FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDAs, and confirmed that no additional scientific information or data is needed for our application. We will continue to work closely with the FDA to bring this important product to those living with chronic pain and the healthcare professionals who treat them."

EGLT Egalet
$7.52

0.11 (1.48%)

03/15/16
JANY
03/15/16
INITIATION
JANY
Neutral
Egalet initiated with a Neutral at Janney Capital (last night)
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.

TODAY'S FREE FLY STORIES

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BBBY

Bed Bath & Beyond

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BBU

Brookfield Business Partners

$31.08

0.08 (0.26%)

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Brookfield

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MXWL

Maxwell

$6.29

-0.24 (-3.68%)

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Maxwell files to sell $50M of convertible senior notes due 2022 »

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IOVA

Iovance Biotherapeutics

$8.55

0.3 (3.64%)

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Syndicate
Iovance Biotherapeutics files to sell $50M of common stock »

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FB

Facebook

$172.52

2.51 (1.48%)

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ELS

Equity Lifestyle

$87.87

-0.23 (-0.26%)

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BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

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MXWL

Maxwell

$6.29

-0.24 (-3.68%)

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Maxwell enters into Amended and Restated Agreement with Viex »

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MRCY

Mercury Systems

$48.29

0.84 (1.77%)

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HF

HFF Inc.

$37.12

0.12 (0.32%)

16:30
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Hot Stocks
HFF Inc. announces sale of office in Raleigh-Durham, NC for $105.5M »

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16:30
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Options
Preliminary option volume of 13.8M today »

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RYAM

Rayonier Advanced Materials

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ALOG

Analogic

$75.95

-1.35 (-1.75%)

16:28
09/19/17
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Earnings
Analogic sees FY18 EPS $2.70 to $2.90, two estimates consensus $2.80 »

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  • 19

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AMZN

Amazon.com

$969.86

-4.33 (-0.44%)

, TMUS

T-Mobile

$65.42

3.62 (5.86%)

16:28
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General news
On The Fly: Top stock stories for Tuesday »

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AMZN

Amazon.com

$969.86

-4.33 (-0.44%)

TMUS

T-Mobile

$65.42

3.62 (5.86%)

S

Sprint

$8.20

0.52 (6.77%)

VZ

Verizon

$49.34

1.25 (2.60%)

SFTBF

SoftBank

$82.75

4.45 (5.68%)

DTEGY

Deutsche Telekom

$18.75

0.68 (3.76%)

BOBE

Bob Evans

$77.41

4.48 (6.14%)

POST

Post Holdings

$86.36

0.52 (0.61%)

RAD

Rite Aid

$2.40

-0.33 (-12.09%)

WBA

Walgreens Boots Alliance

$81.21

-1.39 (-1.68%)

KSS

Kohl's

$45.38

0.49 (1.09%)

AZO

AutoZone

$535.19

-28.21 (-5.01%)

SNCR

Synchronoss

$9.82

-6.93 (-41.37%)

REV

Revlon

$17.05

1.05 (6.56%)

BBY

Best Buy

$52.76

-4.59 (-8.00%)

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FDX

FedEx

$216.00

0.92 (0.43%)

16:26
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Earnings
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CSTM

Constellium

$10.00

0.4 (4.17%)

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GEMP

Gemphire Therapeutics

$9.65

0.54 (5.93%)

16:25
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Conference/Events
Gemphire Therapeutics to hold a conference call »

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SERV

ServiceMaster

$47.06

0.1 (0.21%)

16:23
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Initiation
ServiceMaster initiated  »

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HSC

Harsco

$19.90

0.4 (2.05%)

16:22
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SBRA

Sabra Health Care

$22.97

-0.47 (-2.01%)

, TPGI

Now owned by PKY

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Sabra to acquire 49% equity interest in senior housing managed by Enlivant »

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SBRA

Sabra Health Care

$22.97

-0.47 (-2.01%)

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  • 26

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SBRA

Sabra Health Care

$22.97

-0.47 (-2.01%)

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Now owned by PKY

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  • 26

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BBBY

Bed Bath & Beyond

16:21
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Hot Stocks
Bed Bath & Beyond reports Q2 SSS from customer-facing digital channels up 20%+ »

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  • 19

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BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

16:20
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Bed Bath & Beyond sees over $150M in savings from transformational initiatives »

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  • 19

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BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

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Hot Stocks
Bed Bath & Beyond repurchased about $56M of common stock in Q2 »

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