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DVAX

Dynavax

$12.48

1.99 (18.97%)

10:55
10/04/16
10/04
10:55
10/04/16
10:55

Dynavax has 'high rejectioin risk' after FDA cancels panel, Feuerstein says

The FDA often rejects drugs after cancelling advisory panels, TheStreet's Adam Feuerstein writes in a new post. The agency cancelled an advisory panel for November to review Dynavax's Heplisav, which suggests "high rejection risk" for the company, he writes. Reference Link

  • 16

    Nov

  • 15

    Dec

DVAX Dynavax
$12.48

1.99 (18.97%)

04/27/16
COWN
04/27/16
NO CHANGE
Target $60
COWN
Outperform
Dynavax PDUFA extension will not impact approval chances, says Cowen
Cowen analyst Phil Nadeau does not beleive Dynavax's Heplisav PDUFA extension by 3 months will impact chances of approval. The analyst suspects that the PDUFA change has more to do with FDA managing its workload than any reflection on the substance of the BLA, since both the FDA and Dynavax had agreed upon the original format of the BLA resubmission. Nadeau continues to rate Dynavax an Outperform and top small cap pick with a $60 price target on shares.
04/27/16
RBCM
04/27/16
DOWNGRADE
RBCM
Sector Perform
Dynavax downgraded to Sector Perform from Outperform at RBC Capital
04/28/16
RBCM
04/28/16
DOWNGRADE
RBCM
Sector Perform
Dynavax downgraded on drug safety concerns at RBC Capital
As noted earlier, RBC Capital downgraded Dynavax to Sector Perform from Outperform, The firm cited concerns about the safety of the company's Heplisav-B drug as the reason for its downgrade. RBC says that the FDA's decision to request individual trial data instead of the integrated dataset shows that the agency's scrutiny of the drug's safety has increased. Target to $17 from $48.
09/06/16
WBLR
09/06/16
NO CHANGE
WBLR
Outperform
FDA panel cancelation positive for Dynavax, says William Blair
William Blair analyst Y. Katherine Xu views the FDA's decision to canceled the November 16 Vaccines and Related Biological Products Advisory Committee meeting for Heplisav as a net positive for Dynavax. The agency's decision to move straight to the PDUFA date suggests that the Heplisav package is "sufficiently strong and adequate to warrant approval in the absence of a panel," Xu tells investors in a research note. She keeps an Outperform rating on Dynavax. The stock is up 19% to $13.00 in pre-market trading.

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COST

Costco

$151.01

-0.76 (-0.50%)

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CMCO

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$27.59

1.07 (4.03%)

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  • 07

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OTTR

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0.1 (0.26%)

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WDC

Western Digital

$63.85

1.76 (2.83%)

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CMCO

Columbus McKinnon

$27.59

1.07 (4.03%)

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  • 07

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HON

Honeywell

$116.25

3.18 (2.81%)

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  • 16

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HRB

H&R Block

$23.42

0.73 (3.22%)

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  • 07

    Dec

APO

Apollo Global

$19.99

0.71 (3.68%)

, CS

Credit Suisse

$15.46

0.77 (5.24%)

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$19.99

0.71 (3.68%)

CS

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0.77 (5.24%)

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  • 07

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  • 14

    Dec

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Canada Capacity Utilization Preview »

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LULU

lululemon

$57.24

0.12 (0.21%)

14:49
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Options
lululemon options imply 14.0% move in share price post-earnings, above median historical move »

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  • 07

    Dec

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Canada Housing Starts Preview »

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ATSG

Air Transport Services

$16.32

0.02 (0.12%)

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AGN

Allergan

$190.01

-0.935 (-0.49%)

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  • 07

    Dec

  • 08

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COST

Costco

$151.01

-0.76 (-0.50%)

, HRB

H&R Block

$23.44

0.75 (3.31%)

14:40
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Earnings
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COST

Costco

$151.01

-0.76 (-0.50%)

HRB

H&R Block

$23.44

0.75 (3.31%)

LULU

lululemon

$57.24

0.12 (0.21%)

CAS

A. M. Castle

UNFI

United Natural Foods

$48.66

-0.7 (-1.42%)

VRNT

Verint

$38.20

0.15 (0.39%)

OLLI

Ollie's Bargain Outlet

$31.50

0.05 (0.16%)

TLRD

Tailored Brands

$18.89

0.58 (3.17%)

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  • 07

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  • 15

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HLT

Hilton

$26.81

0.495 (1.88%)

14:40
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Heightened call activity in Hilton everyday so far in December »

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  • 08

    Dec

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TST

TheStreet

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  • 07

    Dec

SYK

Stryker

$112.97

0.38 (0.34%)

14:34
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Stryker raises quarterly dividend to 42.5c per share »

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  • 12

    Dec

VNCE

Vince Holding

$4.28

0.075 (1.79%)

14:30
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  • 08

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CMA

Comerica

$67.49

-0.2 (-0.30%)

14:30
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Periodicals
Comerica moves higher as company alleged to 'warm' to possible sale »

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  • 17

    Jan

CX

CEMEX

$8.42

0.205 (2.50%)

14:25
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Cemex call volume above normal and directionally bullish »

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14:25
12/07/16
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Conference/Events
Senate Commerce, Science & Transportation Committee to hold a hearing »

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