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AERI

Aerie Pharmaceuticals

$62.95

-1.35 (-2.10%)

13:58
10/13/17
10/13
13:58
10/13/17
13:58

Aerie announces FDA advisory committee vote in favor of Rhopressa

Aerie Pharmaceuticals announced that, in their review of Aerie product candidate Rhopressa, the members of Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration voted as follows on the two points for Advisory Committee consideration: "Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension?" There were ten yes votes and zero no votes. "Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product?" There were nine yes votes and one no vote. The goal date for the FDA to take action under the Prescription Drug User Fee Act, or PDUFA, is February 28, 2018.

  • 13

    Oct

  • 28

    Feb

AERI Aerie Pharmaceuticals
$62.95

-1.35 (-2.10%)

10/02/17
MZHO
10/02/17
NO CHANGE
Target $70
MZHO
Buy
Aerie recent weakness a buying opportunity, says Mizuho
Mizuho analyst Difei Yang noted that Aerie Pharmaceuticals shares have fallen by about 20% since the company announced on September 20 that the FDA will hold an advisory committee meeting to discuss Rhopressa. However, after speaking with Aerie's management, the analyst believes a fair amount of preparation had already taken place prior to receiving the FDA notice and views the pullback in the stock as a buying opportunity. Yang keeps a $70 price target and Buy rating on Aerie shares.
10/05/17
COWN
10/05/17
NO CHANGE
Target $100
COWN
Outperform
Aerie Pharmaceuticals should receive positive FDA review next week, says Cowen
Cowen analyst Tyler Van Buren conducted an ophthalmology panel and survey and received very optimistic responses suggesting Rhopressa should receive a positive advisory committee vote on October 13, which should ultimately lead to approval. The panelists he spoke to believed the company's Rocket clinical trial program demonstrated that Rhopressa is an effective agent as it achieved non-inferiority to timolol, said Van Buren, who reiterated his Outperform rating and $100 price target on Aerie Pharmaceuticals shares.
10/11/17
MZHO
10/11/17
NO CHANGE
MZHO
Buy
FDA stance looks favorable towards Aerie's Rhopressa, says Mizuho
Mizuho analyst Difei Yang said the briefing documents for the FDA's advisory committee meeting to discuss Rhopressa make it appear that the agency's stance is favorable towards Aerie's treatment. The analyst views the FDA's modifications to Aerie's proposed language to be "very minor" and is encouraged by the language used in the indication and usage section. Yang keeps a Buy rating on Aerie Pharmaceuticals shares, which are trading higher following the posting of the meeting documents.
10/11/17
JMPS
10/11/17
NO CHANGE
Target $68
JMPS
Outperform
Rhopressa meeting briefing document 'bullish' for Aerie, says JMP Securities
JMP Securities analyst Donald Ellis called the briefing document for the advisory meeting to review Aerie Pharmaceuticals' Rhopressa "bullish," noting that the document included a statement that the company has shown in three Phase 3 trials that the drug is non-inferior to timolol. "Surprisingly," the FDA included a sample product label, which it rarely does, suggesting the agency "is fully planning on approving Rhopressa," Ellis tells investors. He maintains an Outperform rating and $68 price target on Aerie shares, which are up 16% to $64.20 in afternoon trading.

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JNJ

Johnson & Johnson

$136.12

-0.31 (-0.23%)

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UnitedHealth

$193.20

0.68 (0.35%)

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Morgan Stanley

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MSBI

Midland States

$33.03

-0.07 (-0.21%)

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MYL

Mylan

$38.18

0.23 (0.61%)

, AGN

Allergan

$198.41

-7.11 (-3.46%)

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Mylan CEO: 'Pleased' with court ruling on Allergan's Restasis patents »

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MYL

Mylan

$38.18

0.23 (0.61%)

AGN

Allergan

$198.41

-7.11 (-3.46%)

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NFLX

Netflix

$202.68

3.19 (1.60%)

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PCG

PG&E

$53.43

-4.29 (-7.43%)

18:42
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PG&E sees restoring service to all electric customers in CA affected by fires »

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CYTR

CytRx

$0.38

-0.0142 (-3.64%)

18:29
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CytRx granted listing extension pending results of stockholder vote »

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  • 17

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EADSY

Airbus

$22.75

-0.07 (-0.31%)

, BDRBF

Bombardier

$1.88

0.03 (1.62%)

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Hot Stocks
Airbus and Bombardier announce C Series partnership »

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EADSY

Airbus

$22.75

-0.07 (-0.31%)

BDRBF

Bombardier

$1.88

0.03 (1.62%)

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IMDZ

Immune Design

$10.10

-0.85 (-7.76%)

18:16
10/16/17
10/16
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Conference/Events
Immune Design to host conference call »

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PG

Procter & Gamble

$93.14

0.1 (0.11%)

18:15
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Trian: P&G board election results 'too close to call' »

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  • 20

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AMZN

Amazon.com

$1,006.34

3.4 (0.34%)

18:14
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Periodicals
NJ leaders offer up to $7B in tax incentives to lure Amazon to Newark, WSJ says »

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BDRBF

Bombardier

$1.88

0.03 (1.62%)

, EADSY

Airbus

$22.75

-0.07 (-0.31%)

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Periodicals
Bombardier in talks with Airbus over CSeries jet unit JV, WSJ reports »

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BDRBF

Bombardier

$1.88

0.03 (1.62%)

EADSY

Airbus

$22.75

-0.07 (-0.31%)

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IPXL

Impax

$19.95

-0.85 (-4.09%)

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Impax jumps 6% in after-hours after WSJ says Amneal deal near »

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IPXL

Impax

$19.95

-0.85 (-4.09%)

17:51
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Periodicals
Impax and Amneal close to merger pact, WSJ says »

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  • 09

    Nov

AGII

Argo Group

$62.90

-0.25 (-0.40%)

17:36
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Argo Group provides preliminary Q3 loss estimate »

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FDEF

First Defiance Financial

$53.65

-0.25 (-0.46%)

17:34
10/16/17
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Earnings
First Defiance Financial reports Q3 EPS 92c, consensus 89c »

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  • 17

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BRO

Brown & Brown

$48.97

-0.42 (-0.85%)

17:33
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Earnings
Brown & Brown reports Q3 EPS 53c, consensus 50c »

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  • 17

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ORIG

Ocean Rig UDW

$26.18

0.51 (1.99%)

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NFLX

Netflix

$202.68

3.19 (1.60%)

, IMDZ

Immune Design

$10.10

-0.85 (-7.76%)

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NFLX

Netflix

$202.68

3.19 (1.60%)

IMDZ

Immune Design

$10.10

-0.85 (-7.76%)

SAVE

Spirit Airlines

$33.47

-0.33 (-0.98%)

UNH

UnitedHealth

$193.20

0.68 (0.35%)

BMI

Badger Meter

$50.80

-0.6 (-1.17%)

SONC

Sonic

$24.80

0.42 (1.72%)

ABEO

Abeona Therapeutics

$16.70

0.6 (3.73%)

VICL

Vical

$2.86

0.04 (1.42%)

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FDC

First Data

$18.01

0.39 (2.21%)

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  • 22

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ROSG

Rosetta Genomics

$1.00

-0.0479 (-4.57%)

17:28
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Breaking Syndicate news story on Rosetta Genomics »

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HRS

Harris

$135.90

-0.66 (-0.48%)

17:27
10/16/17
10/16
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17:27
Hot Stocks
Harris awarded $100M government contract modification »

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BA

Boeing

$259.75

-0.99 (-0.38%)

17:26
10/16/17
10/16
17:26
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17:26
Hot Stocks
Boeing awarded $240.2M government contract »

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  • 25

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