Breaking News Instant updates and real-time market news.

DVAX

Dynavax

$10.49

0.16 (1.55%)

11:17
10/03/16
10/03
11:17
10/03/16
11:17

Dynavax jumps after receiving 'anticipated requests' for information from FDA

Earlier today, in a regulatory filing, Dynavax disclosed that Dynavax Technologies received anticipated requests for information from the U.S. Food and Drug Administration's review team in connection with the pending Biologics License Application, BLA, for HEPLISAV-B.The review team's questions are in line with the company's expectations.The company is working with the FDA to resolve remaining questions regarding the BLA in order to enable the FDA to complete its review by the scheduled Prescription Drug User Fee Act, PDUFA, action date of December 15, which remains unchanged. Shares of Dynavax are up 23% or $2.42 to $12.96 per share in morning trading.

  • 16

    Nov

  • 15

    Dec

DVAX Dynavax
$10.49

0.16 (1.55%)

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.

TODAY'S FREE FLY STORIES

ANET

Arista Networks

$94.41

-1.35 (-1.41%)

, CSCO

Cisco

$30.06

0.11 (0.37%)

18:32
12/09/16
12/09
18:32
12/09/16
18:32
Hot Stocks
Arista Networks favored in ITC initial determination on four of six patents »

Arista Networks (ANET)…

ANET

Arista Networks

$94.41

-1.35 (-1.41%)

CSCO

Cisco

$30.06

0.11 (0.37%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

  • 12

    Dec

  • 12

    Dec

TKTDY

Takata Corporation

$10.70

0.05 (0.47%)

18:22
12/09/16
12/09
18:22
12/09/16
18:22
Periodicals
U.S. DOT looks to accelerate pace of Takata air bag replacements, Reuters says »

The U.S. Department of…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

DV

DeVry

$31.90

0.9 (2.90%)

18:17
12/09/16
12/09
18:17
12/09/16
18:17
Hot Stocks
Breaking Hot Stocks news story on DeVry »

International Value…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Dec

CSOD

Cornerstone OnDemand

$39.10

-0.11 (-0.28%)

18:10
12/09/16
12/09
18:10
12/09/16
18:10
Periodicals
Cornerstone OnDemand considers sale amid activist pressure, Bloomberg reports »

Cornerstone OnDemand has…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CVM

CEL-SCI

$0.12

-0.0014 (-1.17%)

18:03
12/09/16
12/09
18:03
12/09/16
18:03
Hot Stocks
NYSE MKT says CEL-SCI noncompliant with certain listing requirements »

CEL-SCI reported on a…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

XOM

Exxon Mobil

$89.00

0.68 (0.77%)

18:01
12/09/16
12/09
18:01
12/09/16
18:01
Periodicals
Exxon CEO Tillerson emerges as top candidate for secretary of state, WSJ says »

Exxon Mobil CEO Rex…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

FUL

H.B. Fuller

$50.36

0.05 (0.10%)

17:58
12/09/16
12/09
17:58
12/09/16
17:58
Hot Stocks
H.B. Fuller announces restructuring, to eliminate, relocate 220 positions »

H.B. Fuller has announced…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

BIIB

Biogen

$287.77

-1.77 (-0.61%)

17:53
12/09/16
12/09
17:53
12/09/16
17:53
Periodicals
Biogen looks like a bargain, Barron's reports »

Biogen trades at just…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

SNY

Sanofi

$40.40

0.63 (1.58%)

17:42
12/09/16
12/09
17:42
12/09/16
17:42
Periodicals
Sanofi to lay off 20% of U.S. diabetes, cardiovascular staff, Bloomberg says »

The layoffs include parts…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 29

    Mar

CSOD

Cornerstone OnDemand

$39.10

-0.11 (-0.28%)

17:38
12/09/16
12/09
17:38
12/09/16
17:38
Periodicals
Cornerstone OnDemand considers sale amid activist pressure, Bloomberg reports »

Investor Praesidium said…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

TACO

Del Taco

$14.75

-0.39 (-2.58%)

17:34
12/09/16
12/09
17:34
12/09/16
17:34
Hot Stocks
Breaking Hot Stocks news story on Del Taco »

PW Acquisitions cuts…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Jan

  • 09

    Jan

  • 09

    Dec

UNVR

Univar

$26.36

0.54 (2.09%)

, BXLT

Baxalta

17:30
12/09/16
12/09
17:30
12/09/16
17:30
Hot Stocks
Univar names Eric Foster chief information officer »

Univar (UNVR) named Eric…

UNVR

Univar

$26.36

0.54 (2.09%)

BXLT

Baxalta

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

PARN

Parnell

$1.42

-0.0031 (-0.22%)

17:30
12/09/16
12/09
17:30
12/09/16
17:30
Hot Stocks
Breaking Hot Stocks news story on Parnell 

Parnell trading resumes

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

BSX

Boston Scientific

$20.81

0.2 (0.97%)

, NVRO

Nevro

$76.38

-1.88 (-2.40%)

17:24
12/09/16
12/09
17:24
12/09/16
17:24
Hot Stocks
Boston Scientific files patent infringement suit against Nevro »

Nevro (NVRO) announced…

BSX

Boston Scientific

$20.81

0.2 (0.97%)

NVRO

Nevro

$76.38

-1.88 (-2.40%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

RTN

Raytheon

$146.30

0.14 (0.10%)

17:21
12/09/16
12/09
17:21
12/09/16
17:21
Hot Stocks
Raytheon awarded $101.9M government contract »

Raytheon Co., Goleta,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CX

CEMEX

$8.77

-0.16 (-1.79%)

17:18
12/09/16
12/09
17:18
12/09/16
17:18
Hot Stocks
CEMEX receives subpoena from SEC regarding Foreign Corrupt Practices Act »

On December 9, 2016,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

PDEX

PRO-DEX

$4.48

0.034 (0.76%)

17:06
12/09/16
12/09
17:06
12/09/16
17:06
Syndicate
Breaking Syndicate news story on PRO-DEX »

PRO-DEX files $25M mixed…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

PFBX

Peoples Financial

$14.50

-0.5 (-3.33%)

17:02
12/09/16
12/09
17:02
12/09/16
17:02
Hot Stocks
Breaking Hot Stocks news story on Peoples Financial »

Jeffrey L. Gendell…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

QUIK

QuickLogic

$0.94

-0.0163 (-1.71%)

17:00
12/09/16
12/09
17:00
12/09/16
17:00
Syndicate
Breaking Syndicate news story on QuickLogic »

QuickLogic files $40M…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

STRZA

Starz

17:00
12/09/16
12/09
17:00
12/09/16
17:00
Hot Stocks
Breaking Hot Stocks news story on Starz »

Elliott Associates…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

BEL

Belmond

16:55
12/09/16
12/09
16:55
12/09/16
16:55
Syndicate
Breaking Syndicate news story on Belmond »

Belmond files automatic…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

PARN

Parnell

$1.42

-0.0031 (-0.22%)

16:55
12/09/16
12/09
16:55
12/09/16
16:55
Hot Stocks
Breaking Hot Stocks news story on Parnell »

Parnell trading halted,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

MS

Morgan Stanley

$43.73

0.15 (0.34%)

, SHAK

Shake Shack

$38.08

0.82 (2.20%)

16:50
12/09/16
12/09
16:50
12/09/16
16:50
Hot Stocks
Breaking Hot Stocks news story on Morgan Stanley, Shake Shack »

Morgan Stanley reports…

MS

Morgan Stanley

$43.73

0.15 (0.34%)

SHAK

Shake Shack

$38.08

0.82 (2.20%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 09

    Jan

MS

Morgan Stanley

$43.73

0.15 (0.34%)

, LXFT

Luxoft

$54.40

-1.8 (-3.20%)

16:44
12/09/16
12/09
16:44
12/09/16
16:44
Hot Stocks
Breaking Hot Stocks news story on Morgan Stanley, Luxoft »

Morgan Stanley reports…

MS

Morgan Stanley

$43.73

0.15 (0.34%)

LXFT

Luxoft

$54.40

-1.8 (-3.20%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

FUL

H.B. Fuller

$50.36

0.05 (0.10%)

16:44
12/09/16
12/09
16:44
12/09/16
16:44
Hot Stocks
H.B. Fuller announces restructuring plan »

On December 7, H.B.…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.