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AMGN

Amgen

$162.42

-1.69 (-1.03%)

09:01
06/19/17
06/19
09:01
06/19/17
09:01

Amgen: FDA accepts sBLA to expand indication for XGEVA

Amgen announced that the U.S. FDA has accepted the XGEVA supplemental Biologics License Application that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. The FDA has set a Prescription Drug User Fee Act action date of Feb. 3, 2018.

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AMGN Amgen
$162.42

-1.69 (-1.03%)

06/12/17
LEER
06/12/17
NO CHANGE
Target $161
LEER
Market Perform
Amgen price target raised to $161 on Neulasta biosimilar delay at Leerink
Leerink analyst Geoffrey Porges noted that Coherus Biosciences (CHRS) received a complete response letter from the FDA for its biosimilar to Amgen's (AMGN) Neulasta, which he views as likely delaying its launch by at least a year. However, the "windfall" is offset by the Supreme Court decision that "effectively eliminates" the 6-month delay for biosimilars associated with notification, Porges tells investors. Based on his forecast for a six-month delay in the timing of a Neulasta biosimilar launch in the U.S., to the second quarter of 2018 from the fourth quarter of 2017, Porges increased his 2018 Amgen revenue forecast by $500M and raised his price target to $161 from $159, though he keeps a Market Perform rating on the stock.
05/22/17
ADAM
05/22/17
NO CHANGE
Target $85
ADAM
Buy
CV events 'may kill' Amgen's romosozumab development, says Canaccord
Canaccord analyst John Newman said Amgen (AMGN) and partner UCB's report of a higher rate of cardiovascular Serious Adverse Events for romosozumab in the Phase 3 ARCH study in osteoporosis suggests a much lower chance of FDA approval for the drug and may "kill" romosozumab's development. He notes that Merck's (MRK) cathepsin-K inhibitor was previously discontinued due to increased risk of atrial fibrillation and stroke. In addition to the safety signals, Newman points out that romosozumab was worse than Radius' (RDUS) Tymlos for non-vertebral fracture and for vertebral fracture, suggesting Radius' drug also has much better efficacy, said the analyst, who keeps a Buy rating and $85 price target on Radius Health shares, which are up $4.47, or 12.8%, to $39.40 in pre-market trading.
05/22/17
LEER
05/22/17
NO CHANGE
Target $159
LEER
Market Perform
Leerink sees only 50/50 chance of Amgen's Evenity hitting market
After Amgen (AMGN) and UCB reported an "imbalance of positively adjudicated serious cardiovascular adverse events" in its Phase 3 study of Evenity, Leerink analyst Geoffrey Porges believes the product now has only a 50/50 probability of coming to market at all. The analyst lowered his price target for Amgen shares to $159 from $160 and keeps a Market Perform rating on the name. Radius Health (RDUS), which has a drug that would compete with Evenity, is trading up 16% to $40.58 in the premarket.
05/22/17
FBCO
05/22/17
NO CHANGE
Target $177
FBCO
Neutral
Amgen romosozumab U.S. approval in July 'off the table,' says Credit Suisse
After Amgen (AMGN) and UCB (UCBJY) announced that the Evenity "ARCH" study met both primary endpoints but that there was also a newly observed cardiovascular safety signal in the trial, Credit Suisse analyst Alethia Young said any potential U.S. approval by the drug's July 19 PDUFA date is "off the table" and it is unclear as of now what U.S. approval timelines may be. She reduced her probability of success for romosozumab to 80% from 100% and lowered her price target on Amgen to $177 from $178. Young keeps a Neutral rating on Amgen shares.

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DUK

Duke Energy

$85.96

-0.32 (-0.37%)

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PPL

PPL Corp.

$38.83

-0.19 (-0.49%)

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AEP

American Electric

$71.55

-0.24 (-0.33%)

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AEE

Ameren

$55.94

-0.33 (-0.59%)

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WEC

WEC Energy

$63.46

-0.17 (-0.27%)

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NSRGY

Nestle

$84.83

0.4 (0.47%)

, LRLCY

L'Oreal

$42.08

0.01 (0.02%)

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$84.83

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$42.08

0.01 (0.02%)

TKTDY

Takata

$3.15

1.2199 (63.21%)

WFM

Whole Foods

$42.95

-0.255 (-0.59%)

WMT

Wal-Mart

$74.84

-0.68 (-0.90%)

AMZN

Amazon.com

$1,003.74

2.44 (0.24%)

VIA

Viacom

$39.15

0.1 (0.26%)

VIAB

Viacom

$34.11

-0.01 (-0.03%)

TWX

Time Warner

$99.70

0.3 (0.30%)

NCR

NCR Corp.

$38.64

0.09 (0.23%)

AIZ

Assurant

$101.25

0.99 (0.99%)

ALXN

Alexion

$126.07

-0.16 (-0.13%)

UTHR

United Therapeutics

$131.59

-0.11 (-0.08%)

RHT

Red Hat

$99.42

0.54 (0.55%)

CI

Cigna

$169.61

-1.07 (-0.63%)

FL

Foot Locker

$48.03

0.53 (1.12%)

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TKTDY

Takata

20:30
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20:30
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Takata says bankruptcy processes should not disrupt airbag recall »

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TKTDY

Takata

$3.15

1.2199 (63.21%)

20:26
06/25/17
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20:26
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Takata says secures $227M debtor-in-possession financing »

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TKTDY

Takata

$3.15

1.2199 (63.21%)

20:24
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06/25
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20:24
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Takata confirms bankruptcy filings »

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TKTDY

Takata

$3.15

1.2199 (63.21%)

20:21
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06/25
20:21
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20:21
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Takata to sell assets, operations to Key Safety Systems »

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IRDM

Iridium

$10.75

0.1 (0.94%)

20:12
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06/25
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Iridium confirms successful second launch of Iridium NEXT satellites »

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TKTDY

Takata

$3.15

1.2199 (63.21%)

20:08
06/25/17
06/25
20:08
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20:08
Periodicals
Takata files for bankruptcy in U.S., Bloomberg says »

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SEAS

SeaWorld

$15.65

-0.16 (-1.01%)

20:01
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06/25
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SeaWorld receives subpoenas, forms special committee over 'Blackfish' statements »

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FB

Facebook

$155.07

1.67 (1.09%)

19:57
06/25/17
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19:57
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19:57
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Facebook plans to offer TV-quality content by late summer, WSJ says »

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FRO

Frontline

$5.59

0.08 (1.45%)

, GNRT

Gener8 Maritime

$6.12

0.21 (3.55%)

19:50
06/25/17
06/25
19:50
06/25/17
19:50
Periodicals
Frontline abandons plans to buy Gener8, WSJ says »

Frontline (FRO) has…

FRO

Frontline

$5.59

0.08 (1.45%)

GNRT

Gener8 Maritime

$6.12

0.21 (3.55%)

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NSRGY

Nestle

$84.83

0.4 (0.47%)

18:46
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Third Point confirms $3.5B stake in Nestle, urges change at company »

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WMT

Wal-Mart

$74.84

-0.68 (-0.90%)

18:23
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Wal-Mart initially clamped down on alcohol, swearing at Jet.com, WSJ says »

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GOOG

Alphabet

$965.59

8.5 (0.89%)

, GOOGL

Alphabet Class A

$986.09

9.47 (0.97%)

17:55
06/25/17
06/25
17:55
06/25/17
17:55
Periodicals
EU plans EUR1B fine against Google this week, FT reports »

The EU plans to levy a…

GOOG

Alphabet

$965.59

8.5 (0.89%)

GOOGL

Alphabet Class A

$986.09

9.47 (0.97%)

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NSRGY

Nestle

$84.83

0.4 (0.47%)

17:37
06/25/17
06/25
17:37
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17:37
Periodicals
Dan Loeb's Third Point targets Nestle, Bloomberg says »

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LNG

Cheniere Energy

$47.62

0.34 (0.72%)

17:27
06/25/17
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Cheniere Energy announces commencement of Korea Gas LNG contract »

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VIA

Viacom

$39.15

0.1 (0.26%)

, VIAB

Viacom

$34.11

-0.01 (-0.03%)

16:20
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Box Office Battle: Fifth 'Transformers' film ekes out $45M in franchise low »

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VIA

Viacom

$39.15

0.1 (0.26%)

VIAB

Viacom

$34.11

-0.01 (-0.03%)

TWX

Time Warner

$99.70

0.3 (0.30%)

DIS

Disney

$104.36

0.14 (0.13%)

LGF.A

Lionsgate

$27.07

0.31 (1.16%)

LGF.B

Lionsgate

$25.38

0.34 (1.36%)

FOX

21st Century Fox

$26.93

0.3 (1.13%)

FOXA

21st Century Fox

$27.19

0.22 (0.82%)

SNE

Sony

$38.52

0.11 (0.29%)

CMCSA

Comcast

$39.50

-0.44 (-1.10%)

CMCSK

Comcast

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GSK

GlaxoSmithKline

$44.29

0.13 (0.29%)

14:42
06/25/17
06/25
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14:42
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GlaxoSmithKline granted Orphan designation for multiple myeloma treatment »

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BHVN

Biohaven Pharmaceutical

$25.33

-0.13 (-0.51%)

14:40
06/25/17
06/25
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14:40
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Biohaven granted Orphan designation for Rett syndrome treatment »

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ESALY

Eisai

$56.42

-0.075 (-0.13%)

14:37
06/25/17
06/25
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14:37
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Eisai unit receives Orphan designation for myelomonocytic leukemia treatment »

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PTNR

Partner Communications

$5.25

0.1123 (2.19%)

14:23
06/25/17
06/25
14:23
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14:23
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Partner Communications executes early loan repayments, sees Q2 expense »

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