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GILD

Gilead

$67.11

0.02 (0.03%)

14:51
12/09/19
12/09
14:51
12/09/19
14:51

Gilead's Kite says results ZUMA-2 trial support regulatory filings

Kite, a Gilead company, announced primary results from ZUMA-2, a global, multicenter, single-arm, open-label Phase 2 study of KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed or refractory mantle cell lymphoma, or MCL. After a single infusion of KTE-X19, the best objective response via independent radiologic central review was 93%, with 67% of patients having achieved a complete response. These findings were presented today at the 61st American Society of Hematology Annual Meeting. With a median follow-up of 12.3 months at the time of data cutoff, 57% of patients remained in an ongoing response. Of the first 28 patients treated, 43% were alive and remained in continued remission without additional therapy. The 12-month estimates of progression-free survival and overall survival were 61% and 83%, respectively. Median duration of response, PFS and OS were not yet reached. Among the 68 patients evaluable for safety, cytokine release syndrome and neurologic events were observed in 91% and 63% of patients, respectively. Grade 3 or higher CRS and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Based on the results of the trial, Kite plans to submit a Biologics License Application for KTE-X19 to the U.S. Food and Drug Administration by the end of this year and a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2020. KTE-X19 has been granted Breakthrough Therapy Designation by the FDA and Priority Medicines by the EMA for relapsed or refractory MCL based on interim data from ZUMA-2.

GILD Gilead
$67.11

0.02 (0.03%)

10/25/19
OPCO
10/25/19
NO CHANGE
Target $80
OPCO
Outperform
Gilead price target lowered to $80 from $85 at Oppenheimer
Oppenheimer analyst Hartaj Singh lowered his price target for Gilead to $80 from $85 and maintained an Outperform rating following the company's Q3 earnings report and investor update. While the quarter was in line with consensus estimates, it missed his expectations by 2% on the top line and bottom line due to one-offs for the HIV/HCV franchise, Singh tells investors in a research note. As new management slot in, Singh says he expects further updates on commercial execution and the pipeline, but HIV continues to be strong, HCV is stabilizing, Yescarta still has "surprising" quarterly variations while the filgotinib filing timelines have firmed up.
10/29/19
RBCM
10/29/19
NO CHANGE
RBCM
Top Pick
Gilead design of Phase 2 study of GS-6207 'intriguing,' says RBC Capital
RBC Capital analyst Brian Abrahams noted that details on Gilead's Phase 2 study for its capsid inhibitor, GS-6207, were posted today on clinicaltrials.gov. He calls the design of the study "intriguing," telling investors that the dose and duration suggest that the drug's profile "may look even better than previously disclosed." The analyst, who sees potential for a transformation of the HIV treatment paradigm away from orals, maintains Gilead shares as a Top Pick.
11/12/19
RHCO
11/12/19
INITIATION
Target $70
RHCO
Hold
Gilead initiated with a Hold at SunTrust
SunTrust analyst Robyn Karnauskas initiated coverage of Gilead with a Hold rating and $70 price target. The analyst notes that while the company's HIV portfolio may offer stable revenues for some time, that is not "enough", as Gilead needs more growth catalysts. Karnauskas adds that the market opportunity for Filgotinib may be large, but its uptake could be "slow".
11/15/19
RBCM
11/15/19
NO CHANGE
Target $158
RBCM
Sector Perform
Galapagos price target raised to $158 from $152 at RBC Capital
RBC Capital analyst Brian Abrahams raised his price target on Galapagos (GLPG) to $158 after the company's R&D day, where the management revealed its "expansive plans for bringing new discovery techniques, treatment modalities, preclinical assets, and targeted indications online" by using the cash from its recent Gilead (GILD) deal. While these "aspirations" will take time to mature, the analyst says the plans are "impressive". Abrahams still keeps his Sector Perform rating on Galapagos shares, noting that its nearer term positives of filgotinib commercialization in RA and potential expansion into IB look priced in.

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SPOT

Spotify

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-3.59 (-2.37%)

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CE

Celanese

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DBD

Diebold

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$84.73

-0.005 (-0.01%)

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iShares 7-10 Year Treasury Bond ETF

$111.28

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SHY

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$84.73

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SPY

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$331.98

1.08 (0.33%)

SLV

iShares Silver Trust

$16.82

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$146.59

0.29 (0.20%)

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UBSFY

Ubisoft

$0.00

(0.00%)

17:32
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Ubisoft to restructure editorial team after difficult 2019, VGC reports »

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IMVT

Immunovant

$17.04

-0.01 (-0.06%)

17:27
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Syndicate
Breaking Syndicate news story on Immunovant »

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TBLT

ToughBuilt

$0.33

-0.0255 (-7.11%)

17:20
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Syndicate
ToughBuilt files to sell common stock, no amount given »

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MYO

Myomo

$0.32

0.0062 (1.98%)

17:18
01/17/20
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Conference/Events
Myomo to host special shareholder meeting »

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  • 21

    Jan

SRRA

Sierra Oncology

$0.40

-0.02 (-4.76%)

17:14
01/17/20
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Conference/Events
Sierra Oncology to host virtual special shareholder meeting »

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  • 21

    Jan

SRNE

Sorrento Therapeutics

$4.26

-0.15 (-3.40%)

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AKER

Akers Biosciences

$3.45

-0.1 (-2.82%)

17:01
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ECA

Encana

$4.09

-0.18 (-4.22%)

16:40
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Encana receives court approval for reorganization »

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  • 29

    Jan

MBRX

Moleculin Biotech

$0.96

0.0122 (1.29%)

16:38
01/17/20
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Breaking Syndicate news story on Moleculin Biotech »

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VOD

Vodafone

$20.07

-0.225 (-1.11%)

, BT

BT Group

$0.00

(0.00%)

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BT, Vodafone consider urging PM Johnson not to ban Huawei in U.K., Reuters says »

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Vodafone

$20.07

-0.225 (-1.11%)

BT

BT Group

$0.00

(0.00%)

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16:30
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Options
Preliminary option volume of 28.7M today »

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NSCO

Nesco Holdings

$5.12

0.025 (0.49%)

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Nesco Holdings requests withdrawal of registration statement »

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GPS

Gap

$18.54

-0.075 (-0.40%)

, CMCSA

Comcast

$47.48

0.62 (1.32%)

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GPS

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-0.075 (-0.40%)

CMCSA

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0.62 (1.32%)

CMCSK

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$0.00

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PLAY

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KKR

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$31.20

0.7 (2.30%)

BA

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JNJ

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$149.07

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TWOU

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BE

Bloom Energy

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MGPI

MGP Ingredients

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FAST

Fastenal

$36.77

-0.55 (-1.47%)

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    Mar

APLS

Apellis

$40.43

0.03 (0.07%)

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

16:17
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$NYE

NYSE Market Internals

$0.00

(0.00%)

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16:15
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LGC

Legacy Acquisition Corp

$10.33

(0.00%)

16:08
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Legacy Acquisition Corp extends date to consummate proposed business combination »

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GNUS

Genius Brands

$0.33

-0.015 (-4.41%)

16:04
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Syndicate
Breaking Syndicate news story on Genius Brands »

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BBY

Best Buy

$90.21

1.28 (1.44%)

16:04
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Best Buy board opens investigation into CEO's personal conduct, WSJ says »

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