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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

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BBSI

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MB

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ANET

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ANET

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TKTDY

Takata Corporation

$10.70

0.05 (0.47%)

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DV

DeVry

$31.90

0.9 (2.90%)

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  • 09

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CSOD

Cornerstone OnDemand

$39.10

-0.11 (-0.28%)

18:10
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CVM

CEL-SCI

$0.12

-0.0014 (-1.17%)

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XOM

Exxon Mobil

$89.00

0.68 (0.77%)

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Exxon CEO Tillerson emerges as top candidate for secretary of state, WSJ says »

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FUL

H.B. Fuller

$50.36

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BIIB

Biogen

$287.77

-1.77 (-0.61%)

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SNY

Sanofi

$40.40

0.63 (1.58%)

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CSOD

Cornerstone OnDemand

$39.10

-0.11 (-0.28%)

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TACO

Del Taco

$14.75

-0.39 (-2.58%)

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  • 09

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UNVR

Univar

$26.36

0.54 (2.09%)

, BXLT

Baxalta

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UNVR

Univar

$26.36

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BXLT

Baxalta

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PARN

Parnell

$1.42

-0.0031 (-0.22%)

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BSX

Boston Scientific

$20.81

0.2 (0.97%)

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Nevro

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BSX

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$20.81

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NVRO

Nevro

$76.38

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RTN

Raytheon

$146.30

0.14 (0.10%)

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CX

CEMEX

$8.77

-0.16 (-1.79%)

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PDEX

PRO-DEX

$4.48

0.034 (0.76%)

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PFBX

Peoples Financial

$14.50

-0.5 (-3.33%)

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QUIK

QuickLogic

$0.94

-0.0163 (-1.71%)

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Breaking Syndicate news story on QuickLogic »

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STRZA

Starz

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BEL

Belmond

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Breaking Syndicate news story on Belmond »

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PARN

Parnell

$1.42

-0.0031 (-0.22%)

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MS

Morgan Stanley

$43.73

0.15 (0.34%)

, SHAK

Shake Shack

$38.08

0.82 (2.20%)

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MS

Morgan Stanley

$43.73

0.15 (0.34%)

SHAK

Shake Shack

$38.08

0.82 (2.20%)

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