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DVAX

Dynavax

$10.82

0.05 (0.46%)

, MRK

Merck

$62.77

0.11 (0.18%)

17:24
10/09/16
10/09
17:24
10/09/16
17:24

Dynavax reports Phase 1/2 data on SD-101

Dynavax Technologies (DVAX) announced the first presentation of findings from an ongoing Phase 1/2 study evaluating SD-101 in combination with Keytruda, Merck's (MRK) anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naive to anti-PD-1 treatment objective responses were observed in three out of four, including one complete response and two partial responses. One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease. SD-101 in combination with pembrolizumab was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose was not identified. No immune-related adverse events were reported, and the most common treatment-emergent adverse events were grade 1-2 flu-like symptoms, including fever, chills and myalgia consistent with the engagement of TLR9 and production of interferon alpha. The study also included biomarker assessments suggesting that treatment with SD-101 and pembrolizumab resulted in elevation of gene signatures consistent with an increase in immune cell types and multiple immune functions.

DVAX

Dynavax

$10.82

0.05 (0.46%)

MRK

Merck

$62.77

0.11 (0.18%)

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  • 15

    Dec

DVAX Dynavax
$10.82

0.05 (0.46%)

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.
MRK Merck
$62.77

0.11 (0.18%)

09/21/16
FBCO
09/21/16
UPGRADE
Target $41
FBCO
Outperform
Clovis upgraded to Outperform from Neutral at Credit Suisse
Credit Suisse analyst Kennen MacKay upgraded Clovis Oncology (CLVS) to Outperform and raised his price target for the shares to $41 from $19. Clovis closed yesterday up 13%, or $3.92, to $34.83. The potential for a takeover "outweighs concerns surrounding patent life, limited experience in platinum resistant/refractory patients, and PARPi competition," MacKay tells investors in a research note. Clovis could be worth $35-$41 per share in a buyout on operational synergies, and $52-$55 per share with leveraged tax benefits, MacKay estimates. He points out that Eli Lilly (Lill)y, Merck (MRK), Japan's Takeda and others have expressed interest in acquiring U.S. oncology companies.
09/27/16
PIPR
09/27/16
NO CHANGE
Target $62
PIPR
Neutral
Bristol-Myers price target lowered to $62 from $65 at Piper Jaffray
Piper Jaffray analyst Richard Purkiss lowered his price target for Bristol-Myers Squibb (BMY) to $62 saying he sees the company ceding Opdivo's early-mover advantage in lung cancer to competitors. The analyst expects to see details from Roche's (RHHBY) positive OAK trial of Tecentriq vs. docetaxel in non-small cell lung cancer at the upcoming ESMO meeting. Purkiss also expects to see details from Merck's (MRK) positive KEYNOTE-024 trial of Keytruda. The analyst lowered his post-2016 Opdivo forecasts and reiterates a Neutral rating on Bristol shares.
10/03/16
LEER
10/03/16
NO CHANGE
LEER
Market Perform
AASLD abstracts hint at potential competitive threat to Gilead HCV, says Leerink
Leerink analyst Geoffrey Porges says abstracts for the American Association for the Study of Liver Diseases, or AASLD, meeting revealed very limited efficacy information about the new Hepatitis C regimens for Gilead (GILD), Merck (MRK) and AbbVie (ABBV). Nonetheless, the analyst believes the abstracts hint at the potential competitive threat to Gilead's HCV dominance. While the new 12-week HCV regimens may compete on price, the forthcoming 8-week regimens put the most pressure on Gilead's market share, Porges argues. He reiterates a Market Perform rating on Gilead's shares.
10/07/16
LEER
10/07/16
NO CHANGE
LEER
Outperform
Incyte Epacadostat Phase 1 Melanoma data maturing well, says Leerink
Leerink analyst Michael Schmidt says the data from ECHO-202 Phase 1 study evaluating the combination of Incyte's (INCY) IDO1 inhibitor epacadostat with Merck's (MRK) Keytruda confirms the previously published results and appears to be maturing well. The analyst reiterates an Outperform rating on Incyte's shares, saying Jakafi remains a compelling long-term growth driver for the company, expectations for baricitinib are still moderate, and its maturing oncology pipeline of 14 molecules including epacadostat represents a long-term value driver.

TODAY'S FREE FLY STORIES

GOOG

Alphabet

$1,121.76

-0.5 (-0.04%)

, GOOGL

Alphabet Class A

$1,130.70

0.05 (0.00%)

14:39
01/17/18
01/17
14:39
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14:39
Hot Stocks
Google introduces Cloud AutoML to help businesses use machine learning »

In a blog post, Google…

GOOG

Alphabet

$1,121.76

-0.5 (-0.04%)

GOOGL

Alphabet Class A

$1,130.70

0.05 (0.00%)

03/08/13
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CBS

CBS

$59.44

0.01 (0.02%)

, VIAB

Viacom

$31.38

-2.38 (-7.05%)

14:37
01/17/18
01/17
14:37
01/17/18
14:37
Periodicals
Shari Redstone renews push to merge CBS, Viacom, WSJ reports »

Shari Redstone is…

CBS

CBS

$59.44

0.01 (0.02%)

VIAB

Viacom

$31.38

-2.38 (-7.05%)

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JBHT

J.B. Hunt

$120.64

-0.42 (-0.35%)

14:35
01/17/18
01/17
14:35
01/17/18
14:35
Technical Analysis
Technical Earnings Preview: J.B. Hunt near life highs before earnings »

At time of writing and…

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XRX

Xerox

$31.91

-0.44 (-1.36%)

14:35
01/17/18
01/17
14:35
01/17/18
14:35
Hot Stocks
Deason reports 6% stake in Xerox, demands disclosure of JV pact with Fujifilm »

In a regulatory filing,…

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14:35
01/17/18
01/17
14:35
01/17/18
14:35
General news
Treasury Action: yields held near highs »

Treasury Action: yields…

EXAS

Exact Sciences

$52.95

0.33 (0.63%)

, VNRX

VolitionRx

$2.95

0.0441 (1.52%)

14:31
01/17/18
01/17
14:31
01/17/18
14:31
Hot Stocks
Analysts stay bullish on Exact Sciences after ASCO abstract prompts pullback »

Shares of Exact Sciences…

EXAS

Exact Sciences

$52.95

0.33 (0.63%)

VNRX

VolitionRx

$2.95

0.0441 (1.52%)

03/08/13
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AG

First Majestic

$7.36

0.0106 (0.14%)

14:30
01/17/18
01/17
14:30
01/17/18
14:30
Options
Far upside call buyers in First Magestic as shares trade flat »

Far upside call buyers in…

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VNO

Vornado

$71.16

-0.05 (-0.07%)

14:26
01/17/18
01/17
14:26
01/17/18
14:26
Hot Stocks
Vornado raises dividend to 63c per share »

Vornado Realty Trust…

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ALX

Alexander's

$379.05

-3.045 (-0.80%)

14:24
01/17/18
01/17
14:24
01/17/18
14:24
Hot Stocks
Alexander's boosts quarterly dividend to $4.50 per share »

Alexander's…

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JNJ

Johnson & Johnson

$147.07

0.21 (0.14%)

14:22
01/17/18
01/17
14:22
01/17/18
14:22
Hot Stocks
USPTO board says Janssen Oncology patent claims unpatentable »

In a final written…

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LOCO

El Pollo Loco

$10.10

-0.2 (-1.94%)

14:20
01/17/18
01/17
14:20
01/17/18
14:20
Options
Bullish option flow in El Pollo Loco »

Bullish option flow in El…

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14:20
01/17/18
01/17
14:20
01/17/18
14:20
General news
Fed's Beige Book said the economy continued to expand »

Fed's Beige Book…

$NSD

NASDAQ Market Internals

14:17
01/17/18
01/17
14:17
01/17/18
14:17
Technical Analysis
NASDAQ market internals summary »

Volume is above average…

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$NYE

NYSE Market Internals

14:16
01/17/18
01/17
14:16
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14:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

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CRSP

Crispr Therapeutics

$27.18

-1.34 (-4.70%)

14:12
01/17/18
01/17
14:12
01/17/18
14:12
Recommendations
Crispr Therapeutics analyst commentary  »

Piper says European…

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MS

Morgan Stanley

$54.72

0.12 (0.22%)

14:12
01/17/18
01/17
14:12
01/17/18
14:12
Technical Analysis
Technical Earnings Preview: Morgan Stanley near 52-week high before news »

The stock has been…

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  • 18

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INTC

Intel

$43.14

-0.1 (-0.23%)

14:10
01/17/18
01/17
14:10
01/17/18
14:10
Options
Large block of puts in Intel as shares advance »

Large block of puts in…

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WRB

W. R. Berkley

$70.12

0.7 (1.01%)

14:09
01/17/18
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14:09
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Hot Stocks
W. R. Berkley combines professional liability units »

W. R. Berkley announced…

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  • 30

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ONTX

Onconova

$1.74

-0.0901 (-4.92%)

14:05
01/17/18
01/17
14:05
01/17/18
14:05
Downgrade
Onconova rating change  »

Onconova downgraded to…

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  • 17

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CY

Cypress Semiconductor

$16.90

-0.17 (-1.00%)

14:05
01/17/18
01/17
14:05
01/17/18
14:05
Options
Cypress Semiconductor call volume above normal and directionally bullish »

Bullish option flow…

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14:05
01/17/18
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14:05
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14:05
General news
Apple tax repatriation windfall may total $38 B »

Apple tax repatriation…

14:04
01/17/18
01/17
14:04
01/17/18
14:04
General news
Beige Book says employment, wages grew at modest pace »

The latest Beige Book…

14:03
01/17/18
01/17
14:03
01/17/18
14:03
General news
Fed's Beige Book shows 11 Districts reporting modest to moderate gains »

The Federal Reserve Beige…

TRNC

tronc

$17.97

-0.35 (-1.91%)

14:01
01/17/18
01/17
14:01
01/17/18
14:01
Initiation
tronc initiated  »

tronc initiated with a…

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  • 17

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ENDP

Endo

$8.01

0.06 (0.75%)

13:55
01/17/18
01/17
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13:55
Options
Endo put volume heavy and directionally bearish »

Bearish flow noted in…

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