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AMGN

Amgen

$167.50

0.6 (0.36%)

09:12
10/10/16
10/10
09:12
10/10/16
09:12

Amgen: Analyses confirm Vectibix provides survival benefit over chemotherapy

Amgen announced results from new retrospective analyses of key studies with Vectibix in metastatic colorectal cancer patients. The retrospective analysis of the PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival, an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab. Additionally, for this patient population, the retrospective analysis of the PRIME study showed Vectibix plus FOLFOX4 increased OS by 6.7 months when compared to FOLFOX4 alone. These data were presented today at the European Society for Medical Oncology 2016 Congress in Copenhagen. The PEAK and PRIME retrospective analyses, respectively, also showed that mCRC patients with RAS wild-type tumors of left-sided origin receiving Vectibix plus FOLFOX chemotherapy achieved median progression-free survival of 14.6 months, an increase of 3.1 months when compared to FOLFOX plus bevacizumab, and 12.9 months, an increase of 3.7 months when compared to FOLFOX chemotherapy alone. The retrospective analyses found that approximately 80% of tumors originate in the left side of the colon. Additionally, tumors originating in the right side of the colon are currently associated with a poorer prognosis than tumors originating in the left side of the colon. In patients with RAS wild-type mCRC with tumors originating on the right side, a subgroup of patients responded to Vectibix and chemotherapy, achieving numerically higher response rates over chemotherapy with or without bevacizumab. However, no final conclusions can be made regarding the ability to differentiate treatment regimens for patients with right-sided tumors. The safety profile of the use of Vectibix in combination with FOLFOX-based chemotherapy in mCRC has been previously reported. The aggregate safety data is unchanged by this retrospective analysis of outcomes based on CRC tumor site of origin.

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AMGN Amgen
$167.50

0.6 (0.36%)

09/01/16
09/01/16
NO CHANGE

Amgen's sBLA for Blincyto approved by FDA
Amgen's supplemental Biologics License Application for Blincyto has been approved by the FDA to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials. The approval is based on results from the Phase 1/2 '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL. Blincyto was granted breakthrough therapy, priority review and orphan drug designations by FDA, and is now approved in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL. In November 2015, BLINCYTO was granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.
09/27/16
GSCO
09/27/16
NO CHANGE
Target $206
GSCO
Conviction Buy
Goldman surprised by Amgen's Kyprolis outcome in first-line multiple myeloma
Last night, Amgen announced Phase 3 Kypolis CLARION study did not meet the primary endpoint in first-line multiple myeloma. Goldman analyst Terence Flynn was surprised by this outcome given the prior positive superiority data for Kyprolis versus Velcade in the Phase III ENDEAVOR trial. Flynn sees risk to his Kyprolis $1B sales estimate in a first-line setting, but awaits for additional details from the call and further information regarding another ongoing Phase III trial. He expects Amgen shares to be weak on the news but said the company has additional drivers beyond Kyprolis including Repatha for high cholesterol and Erenumab for migraine with additional data expected in 2H 2016 and Q1 2017. Flynn remains Conviction Buy rated on Amgen and maintains his $206 price target.
09/27/16
PIPR
09/27/16
NO CHANGE
PIPR
Overweight
Amgen's Kyprolis in good shape despite trial miss, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer says Amgen's Kyprolis is still likely to be viewed as a "potent backbone, with the right drugs" after a Phase 3 study in front-line myeloma failed to reach its primary endpoint. The analyst believes the impact of the failed trial on Kyprolis use will be limited and he reiterates an Overweight rating on Amgen.
09/29/16
PIPR
09/29/16
NO CHANGE
Target $10
PIPR
Overweight
Arrowhead price target raised to $10 from $8 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Arrowhead Pharmaceuticals (ARWR) to $10 after the company licensed two preclinical cardiovascular RNAi drugs with Amgen (AMGN). Amgen is the "ideal partner" and Arrowhead's balance sheet is now "meaningfully" strengthened, Tenthoff tells investors in a research note. He reiterates an Overweight rating on Arrowhead.

TODAY'S FREE FLY STORIES

CELC

Celcuity

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BSTI

BEST Inc

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GIS

General Mills

$55.38

-1.05 (-1.86%)

20:25
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Notable companies reporting before tomorrow's open »

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PCRX

Pacira

$35.70

-0.6 (-1.65%)

20:00
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Recommendations
Pacira analyst commentary at BMO Capital »

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AVEVF

Aveva

19:56
09/19/17
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19:56
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Upgrade
Aveva rating change at Goldman Sachs »

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ZLAB

Zai Lab

18:58
09/19/17
09/19
18:58
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Syndicate
Zai Lab announces upsizing of U.S. IPO of American depositary shares »

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OHI

Omega Healthcare

$32.53

-0.12 (-0.37%)

18:30
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Omega Healthcare provides hurricane update »

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F

Ford

$11.72

0.09 (0.77%)

18:30
09/19/17
09/19
18:30
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18:30
Periodicals
Ford to slash production at five North American assembly plants, Reuters says »

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FDX

FedEx

$216.00

0.92 (0.43%)

18:26
09/19/17
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18:26
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18:26
Hot Stocks
FedEx says without cyberattack FY18 guidance would not have changed »

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EE

El Paso Electric

$54.85

0.05 (0.09%)

18:25
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Hot Stocks
El Paso Electric announces City of El Paso approved settlement terms »

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BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

18:17
09/19/17
09/19
18:17
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18:17
Hot Stocks
Bed Bath & Beyond says biggest component in drop of FY17 EPS view is operations »

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  • 19

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CPRT

Copart

$32.54

-0.32 (-0.97%)

18:11
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18:11
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Earnings
Copart reports Q4 EPS 30c, consensus 29c »

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  • 20

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STLD

Steel Dynamics

$33.83

0.03 (0.09%)

18:04
09/19/17
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18:04
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Earnings
Steel Dynamics sees Q3 adjusted EPS 63c-67c, consensus 70c »

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XBKS

Xenith Bankshares

$29.96

0.42 (1.42%)

17:58
09/19/17
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Hot Stocks
Treasury exits stake in Xenith Bankshares »

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BMY

Bristol-Myers

$62.93

0.23 (0.37%)

17:54
09/19/17
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17:54
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17:54
Periodicals
Breaking Periodicals news story on Bristol-Myers »

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BBBY

Bed Bath & Beyond

17:54
09/19/17
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17:54
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17:54
Hot Stocks
Breaking Hot Stocks news story on Bed Bath & Beyond »

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  • 19

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DESP

Despegar.com

17:52
09/19/17
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Syndicate
Despegar.com 12.7M share IPO priced at $26.00 »

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  • 20

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WAC

Walter Investment

$0.65

0.186 (40.09%)

17:50
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Walter Investment says Barclays to increase financing available »

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CBAY

CymaBay

17:49
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Initiation
CymaBay initiated at Cantor »

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BBBY

Bed Bath & Beyond

17:46
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Hot Stocks
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  • 19

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EVH

Evolent Health

$15.65

-0.8 (-4.86%)

17:45
09/19/17
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17:45
Initiation
Evolent Health initiated at KeyBanc »

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  • 25

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BPL

Buckeye Partners

$56.33

0.64 (1.15%)

17:44
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Syndicate
Buckeye Partners announces $210M in limited partnership unit sales »

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RL

Ralph Lauren

$91.03

0.87 (0.96%)

17:43
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Initiation
Ralph Lauren initiated at Barclays »

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PVH

PVH Corp.

$127.47

-0.54 (-0.42%)

17:43
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  • 19

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GEMP

Gemphire Therapeutics

$9.65

0.54 (5.93%)

, ORIG

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GEMP

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$9.65

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ORIG

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$0.16

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IOVA

Iovance Biotherapeutics

$8.55

0.3 (3.64%)

BBBY

Bed Bath & Beyond

$27.03

-0.27 (-0.99%)

FDX

FedEx

$216.00

0.92 (0.43%)

ADBE

Adobe

$156.60

0.83 (0.53%)

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