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FCSC

Fibrocell Science

$1.95

-0.07 (-3.47%)

08:28
10/25/18
10/25
08:28
10/25/18
08:28

Fibrocell Science completes Type C meeting with FDA on FCX-007 trial design

Fibrocell Science announced completion of a Type C meeting with the FDA to discuss the design of a Phase 3 clinical trial protocol of FCX-007, the company's gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa, or RDEB. The meeting was facilitated by the current data in Fibrocell's ongoing Phase 1/2 clinical trial of FCX-007 and the recent publication of draft guidance from the FDA in the areas of gene therapy and epidermolysis bullosa. The FDA provided guidance on various design aspects of Fibrocell's proposed Phase 3 clinical trial. In addition, Fibrocell received guidance on chemistry, manufacturing and control, or CMC, requirements for the proposed Phase 3 clinical trial and a potential future biologics license application, or BLA, for FCX-007. Based on the feedback from the meeting, Fibrocell plans to submit the protocol in the Q4 and will provide details on the clinical trial design once it is finalized.

FCSC Fibrocell Science
$1.95

-0.07 (-3.47%)

03/19/18
HCWC
03/19/18
NO CHANGE
Target $6
HCWC
Buy
Fibrocell upcoming catalysts warrant owning shares, says H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis believes upcoming catalysts warrant owning shares of Fibrocell Science. The analyst believes the May 19 data readout for FCX-007 will "represent the beginning of the tipping point for the shares." The readout should catalyze upcoming discussions with the FDA, resulting in what should be a "quick shift" to a pivotal program for the ongoing significant unmet medical need in recessive dystrophic epidermolysis bullosa, Pantginis tells investors in a research note. He reiterates a Buy rating on Fibrocell with a $6 price target.
05/22/18
CANT
05/22/18
NO CHANGE
Target $36
CANT
Overweight
Abeona recent weakness a buying opportunity, says Cantor Fitzgerald
Cantor Fitzgerald analyst Elemer Piros recommends using the recent weakness in shares of Abeona Therapeutics (ABEO) as a buying opportunity. Since May 17, the shares have declined by 25%, following updated presentations and data readouts from an EB-101 competitor, Fibrocell Science (FCSC), Piros tells investors in a research note. Although Fibrocell's initial FCX-007 data may be viewed positively, Abeona's EB-101 remains "best-in-class and first-in-class with positive data in 42 treated wounds, with data up to 36 months," the analyst contends. He reiterates an Overweight rating on Abeona with a $36 price target.

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OXY

Occidental Petroleum

$53.49

0.74 (1.40%)

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TIGR

UP Fintech

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TJX

TJX

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Home Depot

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Home Depot

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AutoZone

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KSS

Kohl's

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EV

Eaton Vance

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JCP

J.C. Penney

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JCOM

j2 Global

$86.48

-0.23 (-0.27%)

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ATTO

Atento

$3.24

-0.14 (-4.14%)

19:58
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Atento sees FY19 revenue flat to up single digits »

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ATTO

Atento

$3.24

-0.14 (-4.14%)

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Atento reports Q1 recurring EPS (6c), consensus 10c »

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ITCB

Itau Corpbanca

$12.95

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Itau Corpbanca dissolves subsidiary Corplegal »

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OCUL

Ocular Therapeutix

$3.36

-0.1 (-2.89%)

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Recommendations
Ocular Therapeutix analyst commentary at Piper Jaffray »

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YGYI

Youngevity

$6.57

0.13 (2.02%)

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360 Finance

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YGYI

Youngevity

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QFIN

360 Finance

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0.71 (4.51%)

ARWR

Arrowhead

$18.94

-0.52 (-2.67%)

TRIP

TripAdvisor

$44.93

-0.07 (-0.16%)

ASNA

Ascena Retail

$1.13

-0.125 (-9.96%)

KR

Kroger

$24.04

-0.18 (-0.74%)

SNAP

Snap

$11.19

-0.3 (-2.61%)

NDSN

Nordson

$130.42

-4.8 (-3.55%)

OCUL

Ocular Therapeutix

$3.36

-0.1 (-2.89%)

SWI

SolarWinds

$19.16

0.04 (0.21%)

MRCY

Mercury Systems

$72.85

-0.11 (-0.15%)

VNE

Veoneer

$18.89

0.02 (0.11%)

GH

Guardant Health

$78.29

2.13 (2.80%)

CVNA

Carvana

$67.17

-0.935 (-1.37%)

INSM

Insmed

$28.08

-1.08 (-3.70%)

VAR

Varian Medical

$130.48

-0.26 (-0.20%)

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TOL

Toll Brothers

$37.52

-0.88 (-2.29%)

18:47
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Toll Brothers acquires Sharp Residential, terms not disclosed »

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TTWO

Take-Two

$102.94

-3.82 (-3.58%)

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Take-Two CEO: Our job is to excite customers »

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AAL

American Airlines

$30.96

-0.8 (-2.52%)

18:40
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Periodicals
American Air asks court to halt alleged mechanics unions' slowdown, Reuters says »

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LWAY

Lifeway Foods

$2.75

0.05 (1.85%)

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Earnings
Lifeway Foods reports Q1 EPS (2c) vs. 0c last year »

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WHLR

Wheeler REIT

$2.25

0.025 (1.13%)

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Wheeler REIT chairman John Sweet to resign »

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WMT

Walmart

$101.54

0.66 (0.65%)

, TGT

Target

$72.10

1.22 (1.72%)

18:03
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Periodicals
Judge says Walmart, Target, Bed Bath must face suits over cotton, Reuters says »

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WMT

Walmart

$101.54

0.66 (0.65%)

TGT

Target

$72.10

1.22 (1.72%)

BBBY

Bed Bath & Beyond

$14.48

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QFIN

360 Finance

$16.46

0.71 (4.51%)

18:02
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Earnings
360 Finance reports Q1 net income $117.5M, up 382% from last year »

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MRK

Merck

$78.86

0.15 (0.19%)

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Merck falls after Keytruda trial does not meet OS primary endpoint »

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PRIM

Primoris

$20.26

-0.08 (-0.39%)

17:55
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Primoris director sells 99.8K shares of common stock »

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BK

BNY Mellon

$45.97

-0.11 (-0.24%)

, LM

Legg Mason

$35.68

0.295 (0.83%)

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Hot Stocks
BNY Mellon announces Ed Garden to step down from board of directors »

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BNY Mellon

$45.97

-0.11 (-0.24%)

LM

Legg Mason

$35.68

0.295 (0.83%)

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DHR

Danaher

$130.33

-0.81 (-0.62%)

17:44
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VP of Danaher Angela Lalor sells over $408K in company shares »

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SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$283.95

-2.03 (-0.71%)

17:43
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17:43
Periodicals
Judge dismisses Trump request to block accounting subpoena, WSJ says »

U.S. District Judge Amit…

SPX

S&P 500

$0.00

(0.00%)

SPY

SPDR S&P 500 ETF Trust

$283.95

-2.03 (-0.71%)

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LM

Legg Mason

$35.68

0.295 (0.83%)

17:40
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Legg Mason names Nelson Peltz, Ed Garden to board of directors »

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