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KITE

Kite Pharma

$111.43

2.55 (2.34%)

08:38
07/31/17
07/31
08:38
07/31/17
08:38

Kite Pharma files CAR-T MAA in Europe for axicabtagene ciloleucel

Kite Pharma announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant. This application represents the first chimeric antigen receptor T-cell therapy submitted to the EMA. Axicabtagene ciloleucel is currently under review by the U.S. Food and Drug Administration, and the FDA has set a Prescription Drug User Fee Act action date of November 29. The MAA for axicabtagene ciloleucel is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate, with 82% of patients achieving a response after a single infusion of axicabtagene ciloleucel. At a median follow-up of 8.7 months, 44% of patients were in ongoing response, which included 39% of patients in complete response. The most common Grade 3 or higher adverse events included cytokine release syndrome and neurologic events, which were generally reversible.

  • 28

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KITE Kite Pharma
$111.43

2.55 (2.34%)

07/13/17
07/13/17
DOWNGRADE

Hold
Kite Pharma downgraded to Hold at Maxim
As previously reported, Maxim analyst Jason McCarthy downgraded Kite Pharma to Hold from Buy as he believes approval and success in relapsed/refractory blood cancers is already being factored in at the stock's current valuation. While "there is much more to come" from T-cell based oncology therapies, the focus for Kite is set to shift to "not if, but when and how much," McCarthy tells investors.
07/13/17
MAXM
07/13/17
DOWNGRADE
MAXM
Hold
Kite Pharma downgraded to Hold from Buy at Maxim
07/13/17
SBSH
07/13/17
NO CHANGE
SBSH
Novartis vote bodes well for Kite and Juno, says at Citi
Citi analyst Robyn Karnauskas believes the FDA's unanimous vote in favor of Novartis' (NVS) CAR-T bodes well for Kite Pharma (KITE) and Juno Therapeutics (JUNO). Yesterday's panel meeting provides a preview of what Kite can expect ahead of its November 29 FDA action date, Karnauskas tells investors in a research note. She believes the expert commentary from the panel has "overarching implications" for Kite and Juno, both of which are developing CAR-T therapies for multiple indications.
07/10/17
JEFF
07/10/17
NO CHANGE
Target $121
JEFF
Buy
Jefferies ups Kite target to $121 on 'relatively benign' FDA docs
Jefferies analyst Biren Amin raised his price target for Kite Pharma (KITE) shares to $121 from $101 after the FDA posted briefing documents ahead of the July 12 committee meeting disusing Novartis' (NVS) CAR-T therapy CTL019. The documents for the first CAR-T therapy seem "relatively benign," Amin tells investors in a research note. The FDA's view of CAR-T therapies looks in-line with expectations, but the agency may require long-term follow-up of patients to assess for risk of secondary malignancies, Amin writes. He keeps a Buy rating on Kite Pharma. The stock in late morning trading is down 3% to $102.55.

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REGI

Renewable Energy

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INTC

Intel

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Former Intel CFO Stacy Smith to retire at the end of January, 2018 »

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COL

Rockwell Collins

$124.29

0.6 (0.49%)

18:36
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18:36
Upgrade
Rockwell Collins rating change at Vertical Research »

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CRM

Salesforce

$92.95

1.19 (1.30%)

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Salesforce CEO says closed large deal with Veterans Administration »

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WWR

Westwater Resources

$1.32

-0.14 (-9.59%)

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Westwater Resources acquires water rights for Columbus Basin Project in Nevada »

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ZTO

ZTO Express

$14.01

0.11 (0.79%)

18:03
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Earnings
Breaking Earnings news story on ZTO Express »

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ZTO

ZTO Express

$14.01

0.11 (0.79%)

18:02
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Earnings
ZTO Express reports Q2 earnings per ADS 15c, consensus 14c »

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URI

United Rentals

$112.44

4.04 (3.73%)

, CMI

Cummins

$153.10

1.04 (0.68%)

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United Rentals acquires power equipment assets from Cummins »

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URI

United Rentals

$112.44

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CMI

Cummins

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1.04 (0.68%)

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MXIM

Maxim Integrated

$44.39

0.68 (1.56%)

, LZB

La-Z-Boy

$31.25

0.1 (0.32%)

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On The Fly: After Hours Movers »

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MXIM

Maxim Integrated

$44.39

0.68 (1.56%)

LZB

La-Z-Boy

$31.25

0.1 (0.32%)

CREE

Cree

$23.03

0.46 (2.04%)

VNET

21Vianet

$4.58

0.03 (0.66%)

CRM

Salesforce

$92.95

1.19 (1.30%)

RTNB

root9B Technologies

$2.98

1.72 (136.51%)

RARE

Ultragenyx

$58.85

1.94 (3.41%)

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CRM

Salesforce

$92.95

1.19 (1.30%)

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Salesforce says sees FY18 margin up 125-150 bps »

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MXIM

Maxim Integrated

$44.39

0.68 (1.56%)

17:34
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Maxim Integrated names Sumeet Gagneja principal accounting officer »

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CTIC

CTI BioPharma

$3.30

0.01 (0.30%)

17:33
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CTI BioPharma: Chief Business Officer Matthew Plunkett resigns »

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UNM

Unum Group

$47.84

0.51 (1.08%)

17:32
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Syndicate
Breaking Syndicate news story on Unum Group »

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FTK

Flotek

$5.50

-0.1 (-1.79%)

17:29
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Flotek announces conclusion of SEC inquiry »

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CRM

Salesforce

$92.95

1.19 (1.30%)

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Salesforce says 'had best quarter ever' »

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THO

Thor Industries

$103.90

0.45 (0.43%)

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Jayco announces expansion of Middlebury campus, will add 300 jobs »

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GOOG

Alphabet

$924.69

18.03 (1.99%)

, GOOGL

Alphabet Class A

$940.40

19.53 (2.12%)

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Google introduces Chrome Enterprise »

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GOOG

Alphabet

$924.69

18.03 (1.99%)

GOOGL

Alphabet Class A

$940.40

19.53 (2.12%)

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VNET

21Vianet

$4.58

0.03 (0.66%)

17:11
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Earnings
21Vianet reports Q2 EPS (12c), one estimate (11c) »

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RTNB

root9B Technologies

$2.98

1.72 (136.51%)

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root9B Technologies announces incremental funding, status of foreclosure »

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GPT

Gramercy Property Trust

$29.13

-0.03 (-0.10%)

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Gramercy Property Trust launches new JV over Class A distribution centers »

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