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NVCN

Neovasc

$4.02

-0.36 (-8.22%)

08:58
07/12/19
07/12
08:58
07/12/19
08:58

Neovasc to explore HDE approval pathway, alternate trial designs for Reducer

Neovasc announced that the FDA has provided guidance to the company following its Sprint Discussion on June 26, together with the company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer, to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need. In its guidance, the FDA has recommended that the company consider potential alternate approaches such as: the Humanitarian Device Exemption pathway for class IV refractory angina patients and/or alternate clinical trial designs for a broader refractory angina patient population. Based on the FDA's feedback, the company has decided to explore a two-pronged approach. First, the company will work with the FDA to pursue the option for the Reducer to be classified as a Humanitarian Use Device seeking an HDE approval pathway in order to bring this treatment option to those patients in the U.S. with the worst angina symptoms as soon as possible. Second, the company, in close consultation with the FDA and key opinion leaders, will evaluate an alternate investigational device exemption clinical trial design for class III and IV patients.

NVCN Neovasc
$4.02

-0.36 (-8.22%)

03/22/19
ADAM
03/22/19
NO CHANGE
Target $1.1
ADAM
Buy
Neovasc court win in Germany removes overhang, says Canaccord
Canaccord analyst Jason Mills said the ruling yesterday from a German court in dismissing the claim to co-inventorship of the Tiara device made by Edwards Lifesciences' (EW) CardiAQ removes a litigation overhang for Neovasc (NVCN). Mills continues to view Neovasc as an "attractive, albeit admittedly risky," play on the Transcatheter Mitral Valve Repair sector and keeps a Buy rating and $1.10 price target on the shares.

TODAY'S FREE FLY STORIES

01:55
07/19/19
07/19
01:55
07/19/19
01:55
General news
Fed's Williams: Central banks near zero lower bound should act swiftly. »

Fed's Williams:…

SPY

SPDR S&P 500 ETF Trust

$298.86

1.07 (0.36%)

, SPX

S&P 500

$0.00

(0.00%)

20:32
07/18/19
07/18
20:32
07/18/19
20:32
General News
Trump to nominate Gene Scalia as Secretary of Labor »

President Trump tweeted:…

SPY

SPDR S&P 500 ETF Trust

$298.86

1.07 (0.36%)

SPX

S&P 500

$0.00

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AXP

American Express

$128.40

1.355 (1.07%)

, BLK

BlackRock

$474.98

4.06 (0.86%)

20:25
07/18/19
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20:25
07/18/19
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

AXP

American Express

$128.40

1.355 (1.07%)

BLK

BlackRock

$474.98

4.06 (0.86%)

SLB

Schlumberger

$38.78

0.15 (0.39%)

SYF

Synchrony

$36.09

0.54 (1.52%)

STT

State Street

$56.27

1.67 (3.06%)

CFG

Citizens Financial

$34.62

0.27 (0.79%)

RF

Regions Financial

$14.76

0.06 (0.41%)

KSU

Kansas City Southern

$118.03

1.22 (1.04%)

ALV

Autoliv

$69.88

0.04 (0.06%)

GNTX

Gentex

$23.54

0.01 (0.04%)

MAN

ManpowerGroup

$90.30

0.82 (0.92%)

CLF

Cleveland-Cliffs

$10.88

-0.11 (-1.00%)

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POST

Post Holdings

$108.09

0.64 (0.60%)

20:12
07/18/19
07/18
20:12
07/18/19
20:12
Upgrade
Post Holdings rating change at Piper Jaffray »

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VMW

VMware

$174.34

0.13 (0.07%)

19:01
07/18/19
07/18
19:01
07/18/19
19:01
Hot Stocks
VMware to acquire Bitfusion, terms not disclosed »

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  • 03

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CRWD

Crowdstrike

$72.75

1.77 (2.49%)

, SKX

Skechers

$34.75

0.35 (1.02%)

18:50
07/18/19
07/18
18:50
07/18/19
18:50
Hot Stocks
Fly Intel: After Hours Movers »

UP AFTER EARNINGS:…

CRWD

Crowdstrike

$72.75

1.77 (2.49%)

SKX

Skechers

$34.75

0.35 (1.02%)

EXPO

Exponent

$61.63

0.83 (1.37%)

MSFT

Microsoft

$136.29

0.06 (0.04%)

CHWY

Chewy

$32.79

1.14 (3.60%)

RRGB

Red Robin

$30.58

0.32 (1.06%)

GCI

Gannett

$7.90

-0.185 (-2.29%)

IFRX

InflaRx

$3.12

0.05 (1.63%)

BA

Boeing

$361.17

-8.28 (-2.24%)

MVIS

MicroVision

$0.86

0.0458 (5.62%)

OZK

Bank OZK

$28.61

0.5 (1.78%)

ISRG

Intuitive Surgical

$536.44

13.25 (2.53%)

AA

Alcoa

$23.42

0.27 (1.17%)

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MGM

MGM Resorts

$28.75

-0.095 (-0.33%)

, MGP

MGM Growth

$30.00

-0.06 (-0.20%)

18:50
07/18/19
07/18
18:50
07/18/19
18:50
Periodicals
MGM said to consider sale-leaseback of Bellagio, MGM Grand, Bloomberg says »

The report states the…

MGM

MGM Resorts

$28.75

-0.095 (-0.33%)

MGP

MGM Growth

$30.00

-0.06 (-0.20%)

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  • 25

    Jul

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AAL

American Airlines

$33.75

0.5 (1.50%)

, UAL

United Continental

$95.27

0.44 (0.46%)

18:49
07/18/19
07/18
18:49
07/18/19
18:49
Periodicals
POTUS meets with U.S. airlines over Qatar subsidy accusations, Reuters says »

U.S. President Donald…

AAL

American Airlines

$33.75

0.5 (1.50%)

UAL

United Continental

$95.27

0.44 (0.46%)

JBLU

JetBlue

$19.23

0.14 (0.73%)

FDX

FedEx

$165.39

0.375 (0.23%)

AAWW

Atlas Air

$42.58

0.79 (1.89%)

BA

Boeing

$361.17

-8.28 (-2.24%)

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  • 13

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  • 14

    Nov

NUE

Nucor

$54.68

-0.03 (-0.05%)

18:44
07/18/19
07/18
18:44
07/18/19
18:44
Hot Stocks
Nucor CEO: We are very pleased with the results from the tariffs »

In an interview on…

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  • 18

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NABZY

National Australia Bank

$0.00

(0.00%)

18:30
07/18/19
07/18
18:30
07/18/19
18:30
Hot Stocks
National Australia Bank names Ross McEwan as new CEO »

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BAC

Bank of America

$29.48

0.3 (1.03%)

18:22
07/18/19
07/18
18:22
07/18/19
18:22
Hot Stocks
Bank of America CEO: Millennials are a huge customer base for us »

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  • 06

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    Oct

TAP

Molson Coors

$54.37

0.08 (0.15%)

18:06
07/18/19
07/18
18:06
07/18/19
18:06
Hot Stocks
Molson Coors raises quarterly dividend to 57c from 41c per share »

Molson Coors declared a…

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  • 31

    Jul

MSFT

Microsoft

$136.29

0.06 (0.04%)

18:04
07/18/19
07/18
18:04
07/18/19
18:04
Hot Stocks
Breaking Hot Stocks news story on Microsoft »

Microsoft up over 2%…

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BAS

Basic Energy

$1.81

-0.1 (-5.24%)

18:02
07/18/19
07/18
18:02
07/18/19
18:02
Hot Stocks
Basic Energy announces record setting lateral completion in Permian Basin »

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MSFT

Microsoft

$136.29

0.06 (0.04%)

18:02
07/18/19
07/18
18:02
07/18/19
18:02
Hot Stocks
Microsoft CFO continues to expect double digit revenue growth in FY20 »

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QTRH

Quarterhill

$1.23

(0.00%)

18:02
07/18/19
07/18
18:02
07/18/19
18:02
Hot Stocks
WiLAN unit acquires patent portfolio from Vidiator »

Wi-LAN announced that…

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MSFT

Microsoft

$136.29

0.06 (0.04%)

18:00
07/18/19
07/18
18:00
07/18/19
18:00
Earnings
Microsoft sees total Q1 revenue at implied $31.7B-$32.4B, consensus $32.0B »

By segment: Sees Q1…

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  • 18

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RRGB

Red Robin

$30.58

0.32 (1.06%)

18:00
07/18/19
07/18
18:00
07/18/19
18:00
Hot Stocks
Red Robin up 17% after confirming $40.00 per share offer from Vintage Capital »

In after-hours trading,…

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T

AT&T

$33.09

-0.17 (-0.51%)

17:54
07/18/19
07/18
17:54
07/18/19
17:54
Periodicals
AT&T mulls sale of Puerto Rican business to pay down debt, Bloomberg says »

AT&T, which is eyeing…

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RRGB

Red Robin

$30.58

0.32 (1.06%)

17:53
07/18/19
07/18
17:53
07/18/19
17:53
Hot Stocks
Red Robin confirms $40.00 per share cash buyout proposal from Vintage Capital »

Red Robin confirmed it…

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MSFT

Microsoft

$136.29

0.06 (0.04%)

17:50
07/18/19
07/18
17:50
07/18/19
17:50
Hot Stocks
Microsoft CFO: Q4 another quarter of double-digit top and bottom line growth »

Says commercial bookings…

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  • 18

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HBIO

Harvard Bioscience

$1.78

0.03 (1.71%)

17:46
07/18/19
07/18
17:46
07/18/19
17:46
Hot Stocks
Harvard Bioscience names Michael Rossi CFO »

Harvard Bioscience has…

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MSFT

Microsoft

$136.29

0.06 (0.04%)

17:43
07/18/19
07/18
17:43
07/18/19
17:43
Hot Stocks
Microsoft CEO seeing growing momentum across every layer of its stack »

Says LinkedIn saw record…

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  • 18

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  • 08

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ISRG

Intuitive Surgical

$536.44

13.25 (2.53%)

17:38
07/18/19
07/18
17:38
07/18/19
17:38
Hot Stocks
Intuitive Surgical falls after Q2 report, despite earnings beat »

Shares of Intuitive are…

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  • 09

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GLD

SPDR Gold Shares

$136.44

1.85 (1.37%)

17:33
07/18/19
07/18
17:33
07/18/19
17:33
Hot Stocks
SPDR Gold Shares holdings rise to 814.62MT from 803.18MT »

This is the highest level…

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