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RCAR

RenovaCare

$7.37

-0.15 (-1.99%)

08:32
02/15/18
02/15
08:32
02/15/18
08:32

RenovaCare announces outcome of pre-submission FDA meeting

RenovaCare announced positive outcomes from its pre-submission meeting with the United States Food and Drug Administration regarding the RenovaCare SkinGun and CellMist System for isolating and spraying a patient's own stem cells onto burns and wounds for rapid self-healing. During the meeting, the FDA provided recommendations that are consistent with the device-specific testing RenovaCare has successfully undertaken and already completed. This testing is valuable to the current study design as well as the follow-on premarketing process. Importantly, the company and the FDA reached alignment on clinical risk mitigation measures, including protocol-specified guidelines and additional investigator and patient education regarding cell harvesting, processing, spraying, and patient follow-up. RenovaCare received targeted feedback from the FDA regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements. The company confirms that it will perform feasibility clinical studies designed in accordance with feedback and guidance from the pre-submission meeting with the FDA.

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AAPL

Apple

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6.93 (3.68%)

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Netflix

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2.94 (0.78%)

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AAPL

Apple

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6.93 (3.68%)

NFLX

Netflix

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2.94 (0.78%)

NYT

New York Times

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TIF

Tiffany

$100.07

3 (3.09%)

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Tiffany CEO: 'Softer trends in second half reflected external challenges' »

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DDAIF

Daimler AG

$0.00

(0.00%)

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Goldman to aid Daimler grow stake in its main China JV partner, Reuters says »

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TIF

Tiffany

$100.07

3 (3.09%)

06:42
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Earnings
Tiffany sees FY19 EPS up mid-single-digit percentage, consensus $4.93 »

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JKS

JinkoSolar

$19.65

-1.91 (-8.86%)

06:41
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TIF

Tiffany

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3 (3.09%)

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BKNG

Booking Holdings

$1,772.07

-1.48 (-0.08%)

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TIF

Tiffany

$100.07

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LW

Lamb Weston

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  • 02

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ICE

IntercontinentalExchange

$73.36

0.15 (0.20%)

, BTC

Bitcoin

$0.00

(0.00%)

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ICE's bitcoin futures launch stalls over CFTC regulation talks, WSJ reports »

Intercontinental Exchange…

ICE

IntercontinentalExchange

$73.36

0.15 (0.20%)

BTC

Bitcoin

$0.00

(0.00%)

BITCOIN

Bitcoin

$0.00

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CMG

Chipotle

$669.87

4.05 (0.61%)

06:39
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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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Hibbett Sports sees approximately 10-15 new store openings in FY20 »

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  • 22

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STG

Sunlands Online

$4.25

-0.03 (-0.70%)

06:37
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Earnings
Sunlands Online reports Q4 EPS ($3.88), one estimate (22c) »

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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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Hibbett Sports announces planned retirement of CEO Jeff Rosenthal »

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  • 22

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BIIB

Biogen

$226.71

-93.76 (-29.26%)

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NKE

Nike

$88.05

1.3597 (1.57%)

06:34
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Nike analyst commentary  »

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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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Earnings
Hibbett Sports sees FY20 adjusted EPS $1.80-$2.00, consensus $1.75 »

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  • 22

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RVEN

Reven Housing

$3.85

(0.00%)

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Reven Housing announces review of strategic alternatives »

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DB

Deutsche Bank

$8.44

-0.335 (-3.82%)

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Deutsche Bank's workers in the U.S get most of bonus share, Bloomberg says »

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BA

Boeing

$372.69

-3.72 (-0.99%)

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Garuda Indonesia looks to cancel Boeing 737 Max jet order, WSJ reports »

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  • 28

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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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Hot Stocks
Hibbett Sports initiates plan to close underperforming stores »

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  • 22

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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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HIBB

Hibbett Sports

$18.04

-0.46 (-2.49%)

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03/22/19
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Earnings
Hibbett Sports reports Q4 adjusted EPS 57c, consensus 39c »

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  • 22

    Mar

CMC

Commercial Metals

$17.35

1.29 (8.03%)

06:29
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06:29
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Commercial Metals rating change  »

Commercial Metals…

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CAG

Conagra Brands

$25.82

2.915 (12.73%)

06:28
03/22/19
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Recommendations
Conagra Brands analyst commentary  »

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