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RGRX

RegeneRx

$0.22

0.0001 (0.05%)

07:19
04/09/18
04/09
07:19
04/09/18
07:19

RegeneRx announces outcome of FDA discussions on RGN-259

RegeneRx announced the outcome of discussions between its U.S. joint venture, ReGenTree, and the FDA regarding the results of the completed phase 3 clinical trial and the future development requirements for a New Drug Application submission of RGN-259, a novel drug candidate to treat dry eye syndrome. "Although the FDA is requiring an additional phase 3 trial (ARISE-3) to further demonstrate efficacy in both signs and symptoms of dry eye in a larger patient population, all safety data from ARISE-1 and ARISE-2 were accepted by the FDA, no additional nonclinical efficacy and safety studies are required by the FDA, and the Company's chemistry and manufacturing control plans for the drug substance and drug product were considered complete and acceptable for NDA submission. ReGenTree is now planning to initiate the ARISE-3 trial this year," according to Won Yang, ReGenTree's president and CEO. "We are pleased that we are moving forward with development of RGN-259 for dry eye and that our partner has effectively completed the comprehensive and expensive ancillary work required for an NDA, including the numerous toxicology, stability and manufacturing studies required to bring a new drug to the market," stated J.J. Finkelstein, RegeneRx's president and CEO.

TODAY'S FREE FLY STORIES

IVC

Invacare

$16.50

0.15 (0.92%)

21:30
08/15/18
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21:30
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Invacare rating change  »

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  • 12

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PRO

Pros Holdings

$35.39

-1.91 (-5.12%)

20:39
08/15/18
08/15
20:39
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20:39
Syndicate
Pros Holdings 3.8M share Secondary priced at $34.00 »

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IIN

IntriCon

$63.85

-4.9 (-7.13%)

20:34
08/15/18
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20:34
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20:34
Syndicate
IntriCon 1.5M share Secondary priced at $55.00 »

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ADUS

Addus HomeCare

$59.35

-3.1 (-4.96%)

20:33
08/15/18
08/15
20:33
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20:33
Syndicate
Addus HomeCare 2.1M share Secondary priced at $59.00 »

Jefferies, RBC Capital…

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    Aug

LABL

Multi-Color

$63.90

-1 (-1.54%)

20:32
08/15/18
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20:32
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20:32
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WMT

Walmart

$90.24

-0.565 (-0.62%)

, JCP

J.C. Penney

$2.40

-0.24 (-9.09%)

20:25
08/15/18
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20:25
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20:25
Earnings
Notable companies reporting before tomorrow's open »

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WMT

Walmart

$90.24

-0.565 (-0.62%)

JCP

J.C. Penney

$2.40

-0.24 (-9.09%)

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  • 16

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WUBA

58.com

$58.59

-3.27 (-5.29%)

19:09
08/15/18
08/15
19:09
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19:09
Hot Stocks
Breaking Hot Stocks news story on 58.com »

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WUBA

58.com

$58.59

-3.27 (-5.29%)

19:08
08/15/18
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19:08
Earnings
58.com reports Q2 adjusted earnings per ADS 82c, consensus 68c »

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  • 16

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  • 10

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WAIR

Wesco Aircraft

$13.65

-0.3 (-2.15%)

19:07
08/15/18
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19:07
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19:07
Initiation
Wesco Aircraft initiated at UBS »

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TGI

Triumph Group

$21.10

-0.9 (-4.09%)

19:07
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19:07
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Initiation
Triumph Group initiated at UBS »

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HXL

Hexcel

$68.40

-1.13 (-1.63%)

19:06
08/15/18
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19:06
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19:06
Initiation
Hexcel initiated at UBS »

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  • 06

    Nov

ERJ

Embraer

$18.64

-0.495 (-2.59%)

19:05
08/15/18
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19:05
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19:05
Initiation
Embraer initiated at UBS »

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CW

Curtiss-Wright

$130.92

-2.42 (-1.81%)

19:04
08/15/18
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19:04
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19:04
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Curtiss-Wright initiated at UBS »

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LLL

L3 Technologies

$208.08

-1.73 (-0.82%)

19:03
08/15/18
08/15
19:03
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19:03
Initiation
L3 Technologies initiated at UBS »

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GD

General Dynamics

$192.29

-1.33 (-0.69%)

19:03
08/15/18
08/15
19:03
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19:03
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General Dynamics initiated at UBS »

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BDRBF

Bombardier

$0.00

(0.00%)

19:02
08/15/18
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19:02
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19:02
Initiation
Bombardier initiated at UBS »

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HEI

Heico

$76.50

-1.81 (-2.31%)

19:00
08/15/18
08/15
19:00
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Heico initiated at UBS »

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  • 28

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  • 06

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HRS

Harris

$162.73

-2.15 (-1.30%)

18:59
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18:59
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Harris initiated at UBS »

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NOC

Northrop Grumman

$291.52

-2.35 (-0.80%)

18:59
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18:59
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18:59
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Northrop Grumman initiated at UBS »

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PNC

PNC Financial

$142.03

-0.7 (-0.49%)

, WFC

Wells Fargo

$57.99

-0.08 (-0.14%)

18:57
08/15/18
08/15
18:57
08/15/18
18:57
Periodicals
PNC faces subpoenas over low-income housing tax credits, Bloomberg says »

PNC Financial (PNC) has…

PNC

PNC Financial

$142.03

-0.7 (-0.49%)

WFC

Wells Fargo

$57.99

-0.08 (-0.14%)

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  • 12

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UTX

United Technologies

$131.75

-0.65 (-0.49%)

18:57
08/15/18
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18:57
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18:57
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United Technologies initiated at UBS »

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  • 17

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B

Barnes Group

$65.59

-0.26 (-0.39%)

18:56
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18:56
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Barnes Group initiated at UBS »

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SPR

Spirit AeroSystems

$84.51

-1.6 (-1.86%)

18:55
08/15/18
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18:55
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Spirit AeroSystems initiated at UBS »

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TDG

TransDigm

$351.43

-5.195 (-1.46%)

18:54
08/15/18
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Initiation
TransDigm initiated at UBS »

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HII

Huntington Ingalls

$240.82

-2.5 (-1.03%)

18:54
08/15/18
08/15
18:54
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18:54
Initiation
Huntington Ingalls initiated at UBS »

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