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LPCN

Lipocine

$3.80

-0.35 (-8.43%)

08:03
10/17/16
10/17
08:03
10/17/16
08:03

Lipocine completes post action meeting with FDA for LPCN 1021 NDA

Lipocine announced the completion of a Post Action meeting with the FDA regarding its New Drug Application, or NDA, for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter, or CRL, and to determine actions needed to achieve approval of LPCN 1021. The CRL, issued June 28, 2016, identified deficiencies related to the dosing algorithm for the label. In response to the CRL, Lipocine proposed a dosing regimen based on analyses of existing data. The FDA noted that while Lipocine's proposed dosing regimen might be acceptable, validation in a clinical trial would be needed prior to resubmission. As a result, Lipocine has submitted the new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment. An SPA is an advanced declaration from the FDA that a planned trial's design, clinical endpoints, and statistical analyses could potentially result in data acceptable for FDA review towards approval for the proposed indication.

LPCN Lipocine
$3.80

-0.35 (-8.43%)

06/30/16
ROTH
06/30/16
NO CHANGE
Target $30
ROTH
Buy
Lipocine price target lowered to $30 from $40 at Roth Capital
Roth Capital analyst Michael Higgins lowered his price target for Lipocine to $30 from $40 after the FDA issued a Complete Response Letter on Lipocine's oral testosterone product, LPCN 1021, citing "deficiencies related to the dosing algorithm." Roth Capital has a Buy rating on the shares.
10/07/16
HCWC
10/07/16
INITIATION
Target $25
HCWC
Buy
Lipocine initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Corey Davis started Lipocine with a Buy rating and $25 price target.
10/11/16
ADAM
10/11/16
NO CHANGE
Target $15
ADAM
Buy
Lipocine price target raised to $15 from $6 at Canaccord
Canaccord analyst John Newman raised his price target on Lipocine to $15 from $6 as he believes its oral testosterone product has better safety and convenience versus currently marketed gels and injectables. The analyst sees rapid market share gains and a 20% market share by 2024. Newman reiterated his Buy rating on Lipocine shares.

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KHC

Kraft Heinz

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9.37 (10.74%)

, UN

Unilever; also tag UL

$48.79

6.47 (15.29%)

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AAPL

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Apple

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SNAP

Snap Inc

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AMZN

Amazon.com

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FB

Facebook

$133.53

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MSFT

Microsoft

$64.62

0.1 (0.15%)

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$845.07

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Microsoft

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KHC

Kraft Heinz

$96.65

9.37 (10.74%)

, UN

Unilever; also tag UL

$48.79

6.47 (15.29%)

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KHC

Kraft Heinz

$96.65

9.37 (10.74%)

UN

Unilever; also tag UL

$48.79

6.47 (15.29%)

UL

Unilever; also tag UN

$48.53

5.96 (14.00%)

MDLZ

Mondelez

$42.50

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K

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GIS

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CPB

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CL

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KMB

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CLX

Clorox

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DEPO

Depomed

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-0.38 (-2.26%)

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PTEN

Patterson-UTI

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Sabre

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EQM

EQT Midstream Partners

$81.91

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VZ

Verizon

$49.19

0.73 (1.51%)

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GOOG

Alphabet

$828.07

3.91 (0.47%)

, GOOGL

Alphabet Class A

$846.55

4.38 (0.52%)

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GOOG

Alphabet

$828.07

3.91 (0.47%)

GOOGL

Alphabet Class A

$846.55

4.38 (0.52%)

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TOSBF

Toshiba, also use TOSYY

$1.61

-0.182 (-10.17%)

, TOSYY

Toshiba, also use TOSBF

$9.55

-1.085 (-10.21%)

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Toshiba, also use TOSYY

$1.61

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Toshiba, also use TOSBF

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EFOI

Energy Focus

$4.50

-0.21 (-4.46%)

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WMT

Wal-Mart

$69.37

0.5 (0.73%)

, M

Macy's

$32.30

0.48 (1.51%)

20:25
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Earnings
Notable companies reporting before Tuesday's open »

Notable companies…

WMT

Wal-Mart

$69.37

0.5 (0.73%)

M

Macy's

$32.30

0.48 (1.51%)

HD

Home Depot

$143.00

1.46 (1.03%)

SNI

Scripps Networks

$76.04

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MDT

Medtronic

$78.88

0.89 (1.14%)

LL

Lumber Liquidators

$15.36

-0.3 (-1.92%)

GPC

Genuine Parts

$100.67

1.44 (1.45%)

ECL

Ecolab

$123.95

0.67 (0.54%)

CBRL

Cracker Barrel

$168.69

1.14 (0.68%)

AAP

Advance Auto Parts

$161.58

0.59 (0.37%)

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IOC

InterOil

$48.39

0.07 (0.14%)

, XOM

Exxon Mobil

$81.76

-0.54 (-0.66%)

20:22
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InterOil says Yukon approves Exxon Mobil transaction, sees completion this week »

InterOil (IOC) announced…

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InterOil

$48.39

0.07 (0.14%)

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Exxon Mobil

$81.76

-0.54 (-0.66%)

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TWX

Time Warner

$96.48

0.09 (0.09%)

, CMCSA

Comcast

$75.32

-0.67 (-0.88%)

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Against analyst estimates…

TWX

Time Warner

$96.48

0.09 (0.09%)

CMCSA

Comcast

$75.32

-0.67 (-0.88%)

CMCSK

Comcast

LGF.A

Lionsgate

$27.52

-0.18 (-0.65%)

LGF.B

Lionsgate

$25.81

-0.28 (-1.07%)

FOX

21st Century Fox

$29.92

-0.16 (-0.53%)

FOXA

21st Century Fox

$30.35

-0.16 (-0.52%)

DIS

Disney

$110.06

-0.65 (-0.59%)

SNE

Sony

$31.34

0.04 (0.13%)

VIA

Viacom

$47.00

-0.2 (-0.42%)

VIAB

Viacom

$43.99

-0.17 (-0.38%)

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HLX

Helix Energy

$7.41

-0.32 (-4.14%)

19:24
02/20/17
02/20
19:24
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19:24
Earnings
Helix Energy reports Q4 EPS with items (46c), may not compare to consensus (6c) »

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CSII

Cardiovascular Systems

$29.19

0.76 (2.67%)

19:21
02/20/17
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Cardiovascular Systems reports one-year data from COAST study »

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CRMT

America's Car-Mart

$38.85

-1.15 (-2.88%)

19:17
02/20/17
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19:17
Earnings
America's Car-Mart reports Q3 EPS 35c, may not compare to consensus 64c »

Reports Q3 revenue $139M,…

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ROG

Rogers Corporation

$78.80

-1.34 (-1.67%)

19:12
02/20/17
02/20
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19:12
Earnings
Rogers Corporation sees Q1 adjusted EPS $1.09-$1.19, consensus 99c »

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ROG

Rogers Corporation

$78.80

-1.34 (-1.67%)

19:11
02/20/17
02/20
19:11
02/20/17
19:11
Earnings
Rogers Corporation reports Q4 EPS 94c, consensus 82c »

Reports Q4 revenue $173M,…

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HBHC

Hancock Holding

$46.80

-0.2 (-0.43%)

, FNBC

First NBC Bank

$4.75

-0.25 (-5.00%)

19:04
02/20/17
02/20
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19:04
Hot Stocks
Hancock Holding says gets approval to close First NBC Bank transaction »

Hancock Holding (HBHC)…

HBHC

Hancock Holding

$46.80

-0.2 (-0.43%)

FNBC

First NBC Bank

$4.75

-0.25 (-5.00%)

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NDSN

Nordson

$119.95

0.77 (0.65%)

19:03
02/20/17
02/20
19:03
02/20/17
19:03
Earnings
Nordson sees Q2 EPS $1.21-$1.33, consensus $1.22 »

Sees Q2 revenue up 3%-7%.…

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