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AZN

AstraZeneca

$30.27

1.39 (4.81%)

07:02
07/31/17
07/31
07:02
07/31/17
07:02

AstraZeneca says Imfinzi granted breakthrough therapy designation by FDA

AstraZeneca and MedImmune, its global biologics research and development arm, announced that the FDA has granted Breakthrough Therapy Designation for IMFINZI, an anti-PD-L1 monoclonal antibody, being investigated for the treatment of patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. The Breakthrough Therapy Designation for durvalumab was granted on the basis of interim results from the Phase III PACIFIC trial, a randomized, double-blinded, placebo-controlled multi-center trial of durvalumab as sequential treatment in patients with locally-advanced, unresectable NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. This achievement is the fourth Breakthrough Therapy Designation AstraZeneca has received from the FDA for medicines in Oncology over the past three years and the second for durvalumab. In May 2017, AstraZeneca received accelerated approval from the FDA for IMFINZI for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery. IMFINZI is approved under the FDA's accelerated approval pathway, based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Data from the PACIFIC trial have been submitted for presentation at a forthcoming medical meeting. Durvalumab is also being tested in for the treatment of NSCLC in the adjuvant setting in the ADJUVANT Phase III trial. In the Stage IV 1st-line setting for patients with advanced NSCLC, durvalumab as monotherapy and in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, is being tested in the MYSTIC, NEPTUNE and PEARL Phase III trials. The POSEIDON trial is evaluating durvalumab with and without tremelimumab in combination with chemotherapy.

AZN AstraZeneca
$30.27

1.39 (4.81%)

07/28/17
MSCO
07/28/17
DOWNGRADE
MSCO
Equal Weight
AstraZeneca downgraded to Equal Weight from Overweight at Morgan Stanley
Morgan Stanley analyst Vincent Meunier downgraded AstraZeneca to Equal Weight saying shares look fairly valued as he removed MYSTIC from his models. The analyst said AstraZeneca has lower margin recovery prospects and reduced optionality from the pipeline near-term.
07/28/17
RHCO
07/28/17
NO CHANGE
RHCO
Merck, AstraZeneca deal positive, says SunTrust
After Merck (MRK) paid $1.6B upfront for access to Astrazeneca's (AZN) PARP inhibitor, Lynparza and another drug, SunTrust analyst John Boris says that the deal "makes strategic/financial sense and validates the PARP inhibitor class." He adds that the companies are "ideally positioned" to leverage a combination of IO and PARP therapies. The analyst reiterates a $73 price target and a Buy rating on Merck.
07/28/17
LEER
07/28/17
NO CHANGE
Target $61
LEER
Outperform
Bristol-Myers price target lowered to $61 after Astra trial setback at Leerink
Leerink analyst Seamus Fernandez said Bristol-Myers (BMY) reported "solid" Q2 results, including encouraging growth for its key franchises, but he sees increased uncertainty following the failure of AstraZeneca's (AZN) MYSTIC trial, which has potential read through to Bristol's CheckMate-227 trial of its I/O combo of Opdivo + Yervoy. Fernandez lowered his price target on Bristol shares to $61 from $66, but "fully acknowledges" the range of differences in the trial designs. He keeps an Outperform rating on Bristol-Myers, citing prospects for monotherapy Opdivo approval in the second-line setting and success in first-line liver cancer.
07/28/17
07/28/17
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Starbucks (SBUX) was downgraded to Neutral from Buy at Guggenheim and to Hold from Buy at Stifel. 2. Spirit Airlines (SAVE) was downgraded to Neutral from Buy at Buckingham and BofA/Merrill and to In-Line from Outperform at Imperial Capital. 3. Flowers Foods (FLO) downgraded to Hold from Buy at Jefferies with analyst Akshay Jagdale saying his positive thesis on bread industry pricing becoming more rational has not played out. 4. AstraZeneca (AZN) downgraded to Equal Weight from Overweight at Morgan Stanley with analyst Vincent Meunier saying shares look fairly valued as he removed MYSTIC from his models. 5. U.S. Steel (X) downgraded to Sell from Neutral at Citi with analyst Alexander Hacking saying he sees downside risk to U.S. flat rolled prices for the remainder of 2017. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

, BRCD

Brocade

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S&P announces changes to S&P MidCap 400, S&P SmallCap 600 indices »

S&P Dow Jones Indices…

MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

BRCD

Brocade

IVR

Invesco Mortgage

$17.36

0.07 (0.40%)

AVGO

Broadcom

$271.86

-0.25 (-0.09%)

TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

LMOS

Lumos Networks

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WGL

WGL Holdings

$84.32

-0.14 (-0.17%)

18:01
11/17/17
11/17
18:01
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18:01
Earnings
WGL Holdings reports Q4 adjusted EPS (17c), consensus (19c) »

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TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

, LMOS

Lumos Networks

17:58
11/17/17
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17:58
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Tactile Systems to replace Lumos Networks in S&P 600 at open on 11/22 »

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TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

LMOS

Lumos Networks

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IVR

Invesco Mortgage

$17.36

0.07 (0.40%)

, MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

17:56
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17:56
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17:56
Hot Stocks
Breaking Hot Stocks news story on Invesco Mortgage, MKS Instruments »

Invesco Mortgage to…

IVR

Invesco Mortgage

$17.36

0.07 (0.40%)

MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

03/08/13
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03/06/13
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MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

, BRCD

Brocade

17:55
11/17/17
11/17
17:55
11/17/17
17:55
Hot Stocks
MKS Instruments to replace Brocade in S&P 400 at open on 11/22 »

S&P 500 constituent…

MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

BRCD

Brocade

AVGO

Broadcom

$271.86

-0.25 (-0.09%)

03/08/13
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  • 06

    Dec

UQM

UQM Technologies

$1.18

0.015 (1.29%)

17:24
11/17/17
11/17
17:24
11/17/17
17:24
Syndicate
Breaking Syndicate news story on UQM Technologies »

UQM Technologies files to…

03/08/13
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GS

Goldman Sachs

$238.02

-1.35 (-0.56%)

17:23
11/17/17
11/17
17:23
11/17/17
17:23
Periodicals
Goldman Sachs has $510M lawsuit dismissed, Reuters reports »

A $510M lawsuit that…

03/08/13
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VICL

Vical

$1.94

-0.02 (-1.02%)

17:18
11/17/17
11/17
17:18
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17:18
Hot Stocks
Breaking Hot Stocks news story on Vical »

Biotechnology Value Fund…

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LGND

Ligand

$140.31

-1.4 (-0.99%)

17:18
11/17/17
11/17
17:18
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17:18
Hot Stocks
Ligand director sells 5,000 common shares »

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LGND

Ligand

$140.31

-1.4 (-0.99%)

17:17
11/17/17
11/17
17:17
11/17/17
17:17
Hot Stocks
Ligand CFO sells 6,559 common shares »

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LGND

Ligand

$140.31

-1.4 (-0.99%)

17:17
11/17/17
11/17
17:17
11/17/17
17:17
Hot Stocks
Ligand CEO sells 5,269 common shares »

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MBI

MBIA

$9.01

0.13 (1.46%)

17:15
11/17/17
11/17
17:15
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17:15
Hot Stocks
Breaking Hot Stocks news story on MBIA »

Fine Capital Partners…

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RBCN

Rubicon

$8.07

0.1218 (1.53%)

17:03
11/17/17
11/17
17:03
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Breaking Hot Stocks news story on Rubicon »

Bandera Partners reports…

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ANCB

Anchor Bancorp

$24.75

-0.1 (-0.40%)

17:02
11/17/17
11/17
17:02
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17:02
Hot Stocks
Anchor Bancorp announces stock repurchase program, 10b5-1 trading plan »

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GIFI

Gulf Island Fabrication

$12.30

-0.1 (-0.81%)

16:58
11/17/17
11/17
16:58
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Syndicate
Breaking Syndicate news story on Gulf Island Fabrication »

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MPB

Mid Penn Bancorp

$31.09

0.59 (1.93%)

16:51
11/17/17
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Mid Penn Bancorp, Scottdale shareholders approve merger »

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CALD

Callidus Software

$28.95

0.3 (1.05%)

16:49
11/17/17
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16:49
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Initiation
Callidus Software initiated at First Analysis »

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GIFI

Gulf Island Fabrication

$12.30

-0.1 (-0.81%)

16:46
11/17/17
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Hot Stocks
Breaking Hot Stocks news story on Gulf Island Fabrication »

Piton Capital Partners…

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GE

General Electric

$18.21

-0.04 (-0.22%)

16:42
11/17/17
11/17
16:42
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16:42
Hot Stocks
General Electric CEO acquires 60,000 common shares »

In a regulatory filing…

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NRE

Northstar Realty Europe

$14.20

0.05 (0.35%)

16:33
11/17/17
11/17
16:33
11/17/17
16:33
Syndicate
Breaking Syndicate news story on Northstar Realty Europe »

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FHN

First Horizon

$18.40

0.1 (0.55%)

, CBF

Capital Bank

$39.95

0.25 (0.63%)

16:33
11/17/17
11/17
16:33
11/17/17
16:33
Hot Stocks
First Horizon, Capital Bank agree to sell two branches to Apex Bank »

First Horizon (FHN) and…

FHN

First Horizon

$18.40

0.1 (0.55%)

CBF

Capital Bank

$39.95

0.25 (0.63%)

03/08/13
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LII

Lennox

$194.25

-0.75 (-0.38%)

16:32
11/17/17
11/17
16:32
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16:32
Hot Stocks
Lennox executive sells 2,500 common shares »

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TBNK

Territorial Bancorp

$30.99

0.21 (0.68%)

16:31
11/17/17
11/17
16:31
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16:31
Hot Stocks
Territorial Bancorp declares special cash dividend of 30c per share »

Payable on December 20.…

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TRTN

Triton International

$40.07

-0.77 (-1.89%)

16:30
11/17/17
11/17
16:30
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16:30
Hot Stocks
Triton International's Hanau sells 10,000 common shares »

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16:30
11/17/17
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Options
Preliminary option volume of 21.1M today »

Preliminary option volume…

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