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BIIB

Biogen

$223.57

3.52 (1.60%)

06:44
10/22/19
10/22
06:44
10/22/19
06:44

Biogen soars 20% on plans to pursue Alzheimer's approval after FDA talks

Shares of Biogen are soaring after the company announced that, after consulting with the FDA, it plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease. "The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis. This new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid and in reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB). In both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab," The company plans to file a Biologics License Application in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan. Shares of Biogen are up 21% in premarket trading, or $46.49, to $270.00.

  • 22

    Oct

BIIB Biogen
$223.57

3.52 (1.60%)

09/16/19
RBCM
09/16/19
NO CHANGE
RBCM
Biogen Phase II study of BG00011 discontinued due to toxicity, says RBC Capital
RBC Capital analyst Brian Abrahams noted that Biogen's Phase II study of BG00011, formerly STX-100, has been discontinued due to toxicity, and he confirmed this with the company. However, the analyst does not believe the discontinuation will impact shares or valuation, but added that "it does underscore some of the relatively high-risk nature of BIIB's pipeline and removes one of their potential internal diversification opportunities."
10/04/19
GUGG
10/04/19
NO CHANGE
GUGG
Guggenheim positively biased on Biotech heading into earnings
Guggenheim analysts Whitney Ijem, Etzer Darout, Yatin Suneja and Michael Schmidt offered a preview for their joint Biotech coverage ahead of the group's earnings reporting season. Biotech stocks continued their downward trend in the quarter amid negative market sentiment and the analysts think the bar for companies to raise 2019 guidance again may be a bit higher following increases in FY19 consensus estimates on the heels of strong Q2 earnings results. However, they are postively biased on the group and have confidence in FY19 guidance and estimates, the analysts said. They see Alexion (ALXN), Biogen (BIIB), Genmab (GMAB), GW Pharmaceuticals (GWPH), Incyte (INCY), Neurocrine (NBIX), Regeneron (REGN) and Seattle Genetics (SGEN) as well positioned relative to expectations, Ijem, Darout, Suneja and Schmidt tell investors.
10/16/19
MSCO
10/16/19
NO CHANGE
Target $212
MSCO
Underweight
Biogen deadline to settle Tecfidera IPR challenge nearing, says Morgan Stanley
Morgan Stanley analyst Matthew Harrison noted that the USPTO's Patent Trial and Appeal Board will hold an oral hearing on November 13 for an IPR challenge of the only patent that protects Biogen's (BIIB) Tecfidera beyond 2020, after which he believes it will be hard for Biogen to settle out of this case. With that view in mind, he can see a scenario where Biogen reaches a settlement with both Mylan (MYL) and Sawai with a launch date before 2024, in which case he would foresee 1%-5% downside for Biogen shares. In a scenario where Biogen settles with launch date of 2024 or later, Harrison could see 5%-15% upside for Biogen shares. In a scenario where the oral hearing passes without a settlement, the analyst could see 1%-10% downside for Biogen shares. His base case expectation is that Biogen is unlikely to settle the IPR before the hearing, noted Harrison, who keeps an Underweight rating and $212 price target on Biogen shares.
10/16/19
BOFA
10/16/19
INITIATION
Target $200
BOFA
Underperform
Biogen reinstated with an Underperform at BofA/Merrill
BofA/Merrill analyst Geoff Meacham reinstated coverage of Biogen with an Underperform rating and $200 price target, citing competitive risks for Spinraza in SMA, price/share erosion in MS, and a pipeline focused on high risk/reward assets.

TODAY'S FREE FLY STORIES

NCR

NCR Corp.

$32.60

0.16 (0.49%)

20:34
12/11/19
12/11
20:34
12/11/19
20:34
Hot Stocks
NCR enters consent decree to resolve claims related to Kalamazoo River matter »

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  • 11

    Dec

CIEN

Ciena

$35.45

0.75 (2.16%)

, LOVE

Lovesac

$14.49

0.05 (0.35%)

20:25
12/11/19
12/11
20:25
12/11/19
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

CIEN

Ciena

$35.45

0.75 (2.16%)

LOVE

Lovesac

$14.49

0.05 (0.35%)

VERU

Veru

$2.47

0.17 (7.39%)

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    Dec

CHEF

Chefs' Warehouse

$35.51

-0.06 (-0.17%)

20:24
12/11/19
12/11
20:24
12/11/19
20:24
Initiation
Chefs' Warehouse initiated at Piper Jaffray »

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  • 12

    Dec

HSBC

HSBC

$37.15

0.44 (1.20%)

20:13
12/11/19
12/11
20:13
12/11/19
20:13
Upgrade
HSBC rating change at BofA/Merrill »

HSBC upgraded to Buy from…

03/08/13
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PLCE

Children's Place

$54.36

-16.31 (-23.08%)

19:54
12/11/19
12/11
19:54
12/11/19
19:54
Downgrade
Children's Place rating change at Wedbush »

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  • 11

    Dec

LVGO

Livongo Health

$27.55

1.48 (5.68%)

19:43
12/11/19
12/11
19:43
12/11/19
19:43
Syndicate
Livongo Health 2.78M share Secondary priced at $27.00 »

The deal priced below the…

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  • 12

    Dec

CVX

Chevron

$116.22

-1.68 (-1.42%)

19:42
12/11/19
12/11
19:42
12/11/19
19:42
Periodicals
Chevron said to be close to approving Gulf of Mexico project, Bloomberg says »

Bloomberg's Kevin…

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RH

RH

$233.00

0.03 (0.01%)

19:27
12/11/19
12/11
19:27
12/11/19
19:27
Hot Stocks
RH CEO sold 500,000 common shares of company from Dec 9 through Dec 11 »

RH announced that…

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CRWD

Crowdstrike

$47.74

0.18 (0.38%)

19:17
12/11/19
12/11
19:17
12/11/19
19:17
Hot Stocks
Crowdstrike CFO sells 215K shares of common stock »

In a regulatory filing,…

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  • 12

    Dec

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    Dec

GLD

SPDR Gold Shares

$138.94

0.98 (0.71%)

19:00
12/11/19
12/11
19:00
12/11/19
19:00
Hot Stocks
SPDR Gold Shares holdings rise to 886.22MT from 885.93MT »

This is the first…

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DIS

Disney

$147.70

1.58 (1.08%)

, GOOG

Alphabet

$1,345.14

0.64 (0.05%)

18:59
12/11/19
12/11
18:59
12/11/19
18:59
Periodicals
Disney Plus was Google's most searched term in U.S. this year, TechCrunch says »

In the United States in…

DIS

Disney

$147.70

1.58 (1.08%)

GOOG

Alphabet

$1,345.14

0.64 (0.05%)

GOOGL

Alphabet Class A

$1,344.65

1.61 (0.12%)

AAPL

Apple

$270.71

2.09 (0.78%)

T

AT&T

$38.17

0.1 (0.26%)

NFLX

Netflix

$299.25

6.04 (2.06%)

03/08/13
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03/08/13
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03/06/13
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03/06/13
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  • 11

    Dec

  • 29

    Jan

DLHC

DLH Holdings

$4.58

0.525 (12.96%)

, FORM

FormFactor

$23.77

0.57 (2.46%)

18:57
12/11/19
12/11
18:57
12/11/19
18:57
Hot Stocks
Fly Intel: After Hours Movers »

UP AFTER EARNINGS: DLH…

DLHC

DLH Holdings

$4.58

0.525 (12.96%)

FORM

FormFactor

$23.77

0.57 (2.46%)

LULU

Lululemon

$233.31

3.75 (1.63%)

NX

Quanex

$19.72

0.68 (3.57%)

TLRD

Tailored Brands

$4.85

-0.42 (-7.97%)

NDSN

Nordson

$167.44

1.69 (1.02%)

MESA

Mesa Air

$9.25

0.17 (1.87%)

OXM

Oxford Industries

$74.07

-1.89 (-2.49%)

AKTS

Akoustis

$7.60

0.11 (1.47%)

03/08/13
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03/08/13
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03/06/13
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03/06/13
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  • 11

    Dec

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    Dec

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    Dec

  • 18

    Dec

TTD

Trade Desk

$250.44

0.13 (0.05%)

18:57
12/11/19
12/11
18:57
12/11/19
18:57
Hot Stocks
Trade Desk CEO: We don't own any media »

In an interview on…

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RACE

Ferrari

$165.20

0.37 (0.22%)

18:45
12/11/19
12/11
18:45
12/11/19
18:45
Hot Stocks
Ferrari enters into new EUR 350M credit facility »

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RIBT

RiceBran

$2.09

-0.105 (-4.79%)

18:43
12/11/19
12/11
18:43
12/11/19
18:43
Syndicate
RiceBran offers to sell common stock, no amount given »

Lake Street Capital…

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VMW

VMware

$151.00

2.27 (1.53%)

, TSLA

Tesla

$352.40

3.58 (1.03%)

18:42
12/11/19
12/11
18:42
12/11/19
18:42
Hot Stocks
VMware's Poonen: Our networking business is on fire »

In an interview on…

VMW

VMware

$151.00

2.27 (1.53%)

TSLA

Tesla

$352.40

3.58 (1.03%)

DELL

Dell Technologies

$47.73

0.37 (0.78%)

03/08/13
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03/06/13
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  • 11

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  • 07

    Jan

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    Jan

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    Jan

  • 27

    Feb

SMTC

Semtech

$47.36

0.48 (1.02%)

18:38
12/11/19
12/11
18:38
12/11/19
18:38
Hot Stocks
Semtech director sells 19.3K shares of common stock »

In a regulatory filing,…

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  • 07

    Jan

CS

Credit Suisse

$12.95

-0.115 (-0.88%)

18:29
12/11/19
12/11
18:29
12/11/19
18:29
Periodicals
Former Credit Suisse JV exec claims she was put under surveillance, WSJ says »

Colleen Graham, a former…

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  • 11

    Dec

PANW

Palo Alto Networks

$226.76

1.71 (0.76%)

18:22
12/11/19
12/11
18:22
12/11/19
18:22
Hot Stocks
Palo Alto Networks CEO: No systematic problem with our sales »

In an interview on…

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  • 08

    Jan

PBYI

Puma Biotechnology

$8.71

0.24 (2.83%)

18:08
12/11/19
12/11
18:08
12/11/19
18:08
Hot Stocks
Puma Biotechnology presents Phase II results of neratinib in breast cancer »

Puma Biotechnology…

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GTHX

G1 Therapeutics

$23.06

-0.18 (-0.77%)

18:05
12/11/19
12/11
18:05
12/11/19
18:05
Hot Stocks
G1 Therapeutics presents data from Phase 1b/2a trial of lerociclib at SABCS »

G1 Therapeutics reported…

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NH

NantHealth

$0.86

-0.0225 (-2.54%)

18:01
12/11/19
12/11
18:01
12/11/19
18:01
Hot Stocks
NantHealth presents new breast cancer research findings at SABCS »

NantHealth announced new…

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TWTR

Twitter

$30.56

0.71 (2.38%)

, AAPL

Apple

$270.71

2.09 (0.78%)

17:51
12/11/19
12/11
17:51
12/11/19
17:51
Hot Stocks
Twitter announces support for iOS Live Photos that will show as GIFs »

Earlier today Twitter…

TWTR

Twitter

$30.56

0.71 (2.38%)

AAPL

Apple

$270.71

2.09 (0.78%)

03/08/13
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03/06/13
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03/06/13
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  • 06

    Feb

GVA

Granite Construction

$26.29

0.97 (3.83%)

17:46
12/11/19
12/11
17:46
12/11/19
17:46
Hot Stocks
Granite Construction awarded $14M site development project in Illinois »

Granite's…

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MNRL

Brigham Minerals

$18.60

0.4 (2.20%)

17:45
12/11/19
12/11
17:45
12/11/19
17:45
Syndicate
Brigham Minerals 11M share Secondary priced at $18.10 »

Credit Suisse, Goldman…

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  • 12

    Dec

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