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TRVN

Trevena

$0.87

-0.0727 (-7.74%)

12:28
10/12/18
10/12
12:28
10/12/18
12:28

H.C. Wainwright says FDA nod for Trevena's oliceridine unlikely, but possible

H.C. Wainwright analyst Ed Arce said he does not believe the FDA's approval decision about Trevena's oliceridine is "a foregone conclusion" following yesterday's advisory committee meeting given the mixed vote on approvability. After the vote, at least three panelists who voted "no" said that they struggled with their decision and could have easily voted "yes," according to Arce, who said there is a possibility, "however unlikely," that the FDA could still approve the drug. While he views the November 2 decision as "too hard to call" and keeps a Buy rating on Trevena shares, Arce lowered his price target on the stock to $3 from $7.

  • 02

    Nov

TRVN Trevena
$0.87

-0.0727 (-7.74%)

10/10/18
JEFF
10/10/18
DOWNGRADE
Target $1
JEFF
Hold
Trevena downgraded to Hold from Buy at Jefferies
Jefferies analyst Biren Amin downgraded Trevena to Hold and cut his price target for the shares to $1 from $10. The FDA has an unfavorable view on both efficacy and safety profile of the company's oliceridine versus morphine, Amin tells investors in a research following yesterday's briefing documents. More critically, the documents make clear that Trevena failed to heed critical FDA advice in its Phase III trial design, the analyst adds. He sees no clear path forward for oliceridine.
10/12/18
NEED
10/12/18
DOWNGRADE
NEED
Hold
Trevena downgraded to Hold from Buy at Needham
10/12/18
NEED
10/12/18
DOWNGRADE
NEED
Hold
Trevena downgraded to Hold at Needham on oliceridine recommendation
As reported earlier, Needham analyst Alan Carr downgraded Trevena to Hold after the FDA's Administration Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, voted 7-8 against the approval of oliceridine use in acute pain management. The analyst notes that documents from the FDA released this week also showed some reluctance in the drug's overall profile, and combined with this latest AADPAC decision, render the approval of oliceridine as improbable. Carr adds that Trevena will likely face challenges obtaining financial resources to support commercial launch even if oliceridine was approved next month, noting that he now awaits the official FDA decision and discussion of development for Trevena's other pipeline programs.
10/12/18
JMPS
10/12/18
NO CHANGE
Target $4
JMPS
Outperform
Trevena price target lowered to $4 from $15 at JMP Securities
JMP Securities analyst Jason Butler said the mixed Advisory Committee vote on Trevena's application for oliceridine is likely to result in an approval delay, but he has not given up on the potential for issues raised by the panel to be addressed with label modifications and post-marketing studies. He now assume the company receiving a CRL as his base case scenario, which would result in an 18-month delay to approval. Butler, who cut his probability of approval for oliceridine to 70% from 90% and lowered his peak sales estimate, reduced his price target on Trevena shares to $4 from $15 but keeps an Outperform rating on the stock.

TODAY'S FREE FLY STORIES

XOM

Exxon Mobil

$81.15

-0.83 (-1.01%)

20:43
10/22/18
10/22
20:43
10/22/18
20:43
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Exxon Mobil initiated  »

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VZ

Verizon

$54.96

0.07 (0.13%)

, MCD

McDonald's

$166.53

-0.92 (-0.55%)

20:25
10/22/18
10/22
20:25
10/22/18
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

VZ

Verizon

$54.96

0.07 (0.13%)

MCD

McDonald's

$166.53

-0.92 (-0.55%)

MM

Millennial Media

$0.00

(0.00%)

UTX

United Technologies

$126.42

-2.22 (-1.73%)

LMT

Lockheed Martin

$326.45

-1.77 (-0.54%)

NEE

NextEra Energy

$172.71

-0.76 (-0.44%)

CAT

Caterpillar

$128.64

-2.73 (-2.08%)

BIIB

Biogen

$315.67

-4.18 (-1.31%)

CNC

Centene

$141.34

-1.565 (-1.10%)

GLW

Corning

$30.83

0.06 (0.19%)

PCAR

Paccar

$60.51

0.25 (0.41%)

RF

Regions Financial

$16.39

-0.5 (-2.96%)

FITB

Fifth Third

$25.38

-0.95 (-3.61%)

HBAN

Huntington Bancshares

$13.66

-0.54 (-3.80%)

TRU

TransUnion

$68.59

0.39 (0.57%)

XRX

Xerox

$26.39

-0.47 (-1.75%)

HOG

Harley-Davidson

$38.72

-0.84 (-2.12%)

JBLU

JetBlue

$16.57

0.04 (0.24%)

GPK

Graphic Packaging

$12.31

-0.4 (-3.15%)

SLCA

U.S. Silica

$15.65

-0.41 (-2.55%)

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    Dec

TOT

Total

$59.85

-0.95 (-1.56%)

20:22
10/22/18
10/22
20:22
10/22/18
20:22
Initiation
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RDS.A

Royal Dutch Shell

$64.88

-0.66 (-1.01%)

20:17
10/22/18
10/22
20:17
10/22/18
20:17
Initiation
Royal Dutch Shell initiated  »

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EQNR

Equinor

$26.39

-0.6 (-2.22%)

20:13
10/22/18
10/22
20:13
10/22/18
20:13
Initiation
Equinor initiated  »

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CVX

Chevron

$117.23

-0.82 (-0.69%)

20:11
10/22/18
10/22
20:11
10/22/18
20:11
Initiation
Chevron initiated  »

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  • 02

    Nov

COP

ConocoPhillips

$72.06

-0.43 (-0.59%)

20:06
10/22/18
10/22
20:06
10/22/18
20:06
Initiation
ConocoPhillips initiated  »

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  • 25

    Oct

BP

BP

$43.15

-0.84 (-1.91%)

20:02
10/22/18
10/22
20:02
10/22/18
20:02
Initiation
BP initiated  »

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WRE

Washington REIT

$27.97

-0.305 (-1.08%)

, AAPL

Apple

$220.62

1.34 (0.61%)

19:51
10/22/18
10/22
19:51
10/22/18
19:51
Upgrade
Washington REIT, Apple, Amazon.com rating change  »

Washington REIT upgraded…

WRE

Washington REIT

$27.97

-0.305 (-1.08%)

AAPL

Apple

$220.62

1.34 (0.61%)

AMZN

Amazon.com

$1,789.00

25.09 (1.42%)

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  • 23

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JBGS

JBG Smith Properties

$36.81

0.005 (0.01%)

, AAPL

Apple

$220.62

1.34 (0.61%)

19:47
10/22/18
10/22
19:47
10/22/18
19:47
Upgrade
JBG Smith Properties, Apple, Amazon.com rating change  »

JBG Smith Properties…

JBGS

JBG Smith Properties

$36.81

0.005 (0.01%)

AAPL

Apple

$220.62

1.34 (0.61%)

AMZN

Amazon.com

$1,789.00

25.09 (1.42%)

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  • 23

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ARNC

Arconic

$21.45

-0.45 (-2.05%)

, APO

Apollo Global

$29.47

-0.02 (-0.07%)

19:38
10/22/18
10/22
19:38
10/22/18
19:38
Periodicals
Arconic Board evaluating $11B Apollo Global offer, Reuters reports »

Arconic is said to have…

ARNC

Arconic

$21.45

-0.45 (-2.05%)

APO

Apollo Global

$29.47

-0.02 (-0.07%)

BX

Blackstone

$34.38

-0.28 (-0.81%)

CG

Carlyle Group

$20.46

0.29 (1.44%)

03/08/13
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  • 30

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ARNC

Arconic

$21.45

-0.45 (-2.05%)

, APO

Apollo Global

$29.47

-0.02 (-0.07%)

19:34
10/22/18
10/22
19:34
10/22/18
19:34
Periodicals
Breaking Periodicals news story on Arconic, Apollo Global »

Arconic to consider $11B…

ARNC

Arconic

$21.45

-0.45 (-2.05%)

APO

Apollo Global

$29.47

-0.02 (-0.07%)

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  • 30

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ENLK

EnLink Midstream Partners

$18.10

-0.19 (-1.04%)

19:25
10/22/18
10/22
19:25
10/22/18
19:25
Upgrade
EnLink Midstream Partners rating change  »

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  • 07

    Nov

HLX

Helix Energy

$10.28

0.03 (0.29%)

19:25
10/22/18
10/22
19:25
10/22/18
19:25
Hot Stocks
Helix Energy reports Q3 adjusted EBITDA $58.6M vs. $30.5M last year »

CEO Owen Kratz says:…

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  • 23

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    Nov

HLX

Helix Energy

$10.28

0.03 (0.29%)

19:24
10/22/18
10/22
19:24
10/22/18
19:24
Earnings
Helix Energy reports Q3 adjusted EPS 18c, consensus 11c »

Reports Q3 revenue…

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  • 23

    Oct

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    Nov

UAL

United Continental

$88.62

1.19 (1.36%)

19:13
10/22/18
10/22
19:13
10/22/18
19:13
Periodicals
United CEO upbeat in memo to workers on Q3, SVBJ reports »

In an internal memo to…

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I

Intelsat

$34.98

0.385 (1.11%)

, EUTLF

Eutelsat Communications

$0.00

(0.00%)

19:11
10/22/18
10/22
19:11
10/22/18
19:11
Hot Stocks
Intelsat, SES, Eutelsat in transition on planning to support 5G deployment »

The C-Band Alliance,…

I

Intelsat

$34.98

0.385 (1.11%)

EUTLF

Eutelsat Communications

$0.00

(0.00%)

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  • 30

    Oct

CDNS

Cadence Design

$40.62

0.49 (1.22%)

, SSNC

SS&C

$49.91

-0.37 (-0.74%)

19:05
10/22/18
10/22
19:05
10/22/18
19:05
Hot Stocks
Fly Intel: After Hours Movers »

UP AFTER EARNINGS:…

CDNS

Cadence Design

$40.62

0.49 (1.22%)

SSNC

SS&C

$49.91

-0.37 (-0.74%)

FRBA

First Bank

$12.42

0.015 (0.12%)

ZION

Zions Bancorp

$45.33

-1.64 (-3.49%)

RNST

Renasant

$35.44

-1.1 (-3.01%)

CR

Crane

$87.33

-0.28 (-0.32%)

BRO

Brown & Brown

$29.12

0.27 (0.94%)

CEMI

Chembio Diagnostics

$9.68

-0.05 (-0.51%)

RH

RH

$109.10

-13.485 (-11.00%)

MC

Moelis

$50.66

-0.21 (-0.41%)

AMTD

TD Ameritrade

$49.89

-0.6 (-1.19%)

AFMD

Affimed N.V.

$3.15

-0.06 (-1.87%)

PTI

Proteostasis

$7.17

-0.77 (-9.70%)

EIGR

Eiger BioPharmaceuticals

$10.65

-1.2 (-10.13%)

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DIS

Disney

$118.22

-0.59 (-0.50%)

18:55
10/22/18
10/22
18:55
10/22/18
18:55
Periodicals
Disney spends $20M to support Florida's Amendment 3, Bloomberg says »

Disney and the Seminole…

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  • 08

    Nov

HSBC

HSBC

$40.36

-0.095 (-0.23%)

18:50
10/22/18
10/22
18:50
10/22/18
18:50
Periodicals
HSBC teams up with Avant to offer personal loans, Bloomberg says »

HSBC Holdings is…

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WSFS

WSFS Financial

$43.08

-0.46 (-1.06%)

18:49
10/22/18
10/22
18:49
10/22/18
18:49
Earnings
WSFS Financial reports Q3 EPS 96c, consensus 92c »

Reports Q3 NII $63.1M,…

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  • 23

    Oct

IQV

Iqvia

$126.36

-0.52 (-0.41%)

, CRM

Salesforce

$142.92

2.47 (1.76%)

18:22
10/22/18
10/22
18:22
10/22/18
18:22
Recommendations
Iqvia, Salesforce analyst commentary at Piper Jaffray »

Iqvia price target raised…

IQV

Iqvia

$126.36

-0.52 (-0.41%)

CRM

Salesforce

$142.92

2.47 (1.76%)

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  • 22

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BK

BNY Mellon

$46.47

-0.94 (-1.98%)

18:20
10/22/18
10/22
18:20
10/22/18
18:20
Hot Stocks
BNY Mellon, Bank of the West reach pact on new real-time payments solution »

BNY Mellon and Bank of…

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CLGX

CoreLogic

$45.36

-0.01 (-0.02%)

18:07
10/22/18
10/22
18:07
10/22/18
18:07
Hot Stocks
CoreLogic to acquire Symbility Solutions for CAD159.5M »

Symbility Solutions and…

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  • 25

    Oct

ABBV

AbbVie

$84.27

-3.74 (-4.25%)

18:04
10/22/18
10/22
18:04
10/22/18
18:04
Hot Stocks
AbbVie reports 'positive' data from Phase 2b/3 study of upadacitinib »

AbbVie announced positive…

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  • 02

    Nov

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