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CHMA

Chiasma

$1.40

-0.05 (-3.45%)

16:09
08/10/17
08/10
16:09
08/10/17
16:09

Chiasma reaches agreement with FDA for Phase 3 OPTIMAL trial

Chiasma announced it has reached agreement with the FDA on the design of a new Phase 3 clinical trial for its octreotide capsules product candidate, conditionally trade-named Mycapssa, for the maintenance therapy of adult patients with acromegaly. The agreed-upon study is designed to address the concerns previously raised in the FDA's complete response letter and was reached through special protocol assessment with the FDA's Division of Metabolism and Endocrinology Products. The trial, referred to as OPTIMAL, is a randomized, double-blind, placebo-controlled, nine-month trial in 50 adult acromegaly patients. OPTIMAL utilizes levels of insulin-like growth factor, IGF-1, a byproduct of increased growth hormone levels caused by acromegaly, as the sole primary endpoint measure. The company anticipates release of top-line data from this new Phase 3 clinical trial by the end of 2019. The company continues to enroll patients in its international Phase 3 MPOWERED clinical trial of octreotide capsules for the maintenance treatment of adult patients with acromegaly to potentially support regulatory approval in Europe. However, in order to support enrollment rates for the OPTIMAL Phase 3 clinical trial, Chiasma has significantly reduced the number of sites enrolling patients in the MPOWERED trial.

CHMA Chiasma
$1.40

-0.05 (-3.45%)

01/17/17
LEHM
01/17/17
DOWNGRADE
LEHM
Underweight
Chiasma downgraded to Underweight from Equal Weight at Barclays
01/17/17
01/17/17
DOWNGRADE
Target $2.5

Underweight
Chiasma downgraded to Underweight at Barclays
As previously reported, Barclays downgraded Chiasma to Underweight from Equal Weight and lowered its price target to $2.50 from $5.50. Analyst Douglas Tsao said the path to market in the US for Mycapssa faces significant headwinds and protracted delays. The analyst said recent interactions with the FDA indicate another trial will be required, which would delay market entry until 2021 and consume Chiasma's cash resources.

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BABA

Alibaba

$159.50

1.75 (1.11%)

, WMT

Wal-Mart

$80.98

0.21 (0.26%)

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

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BABA

Alibaba

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Wal-Mart

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ATU

Actuant

$22.90

-0.2 (-0.87%)

19:22
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Actuant agrees to divest Viking SeaTech, acquire Mirage Machines »

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NVO

Novo Nordisk

$46.41

0.9 (1.98%)

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GOOG

Alphabet

$926.96

4.74 (0.51%)

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Alphabet Class A

$944.27

6.19 (0.66%)

18:48
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Periodicals
Google acquires AIMatter, TechCrunch reports »

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GOOG

Alphabet

$926.96

4.74 (0.51%)

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Alphabet Class A

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6.19 (0.66%)

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SRUN

Silver Run

$10.19

0.01 (0.10%)

18:37
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Silver Run merging with Alta Mesa and Kingfisher Midstream into $3.8B company »

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HEI

Heico

$85.55

-0.87 (-1.01%)

18:37
08/16/17
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18:37
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18:37
Downgrade
Heico rating change at Deutsche Bank »

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GPRK

GeoPark

$8.61

-0.13 (-1.49%)

18:36
08/16/17
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Earnings
GeoPark reports Q2 revenue $75.2M, consensus $70.38M »

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MEDP

Medpace

$31.21

-0.16 (-0.51%)

18:14
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Hot Stocks
Medpace announces stock repurchase agreement with Cinven »

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TOUR

Tuniu

$7.76

-0.18 (-2.27%)

18:04
08/16/17
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Earnings
Tuniu reports Q2 EPS (11c), consensus (26c) »

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GLDD

Great Lakes Dredge

$3.85

-0.15 (-3.75%)

18:03
08/16/17
08/16
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Hot Stocks
Great Lakes Dredge CEO acquires 42,610 common shares »

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TISI

Team

$11.10

-0.25 (-2.20%)

18:00
08/16/17
08/16
18:00
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18:00
Hot Stocks
Team director Lois Waters purchases 17,500 shares of company stock »

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NTAP

NetApp

$42.41

0.44 (1.05%)

17:59
08/16/17
08/16
17:59
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17:59
Hot Stocks
Breaking Hot Stocks news story on NetApp »

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NTAP

NetApp

$42.41

0.44 (1.05%)

17:58
08/16/17
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Hot Stocks
Breaking Hot Stocks news story on NetApp »

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NTAP

NetApp

$42.42

0.44 (1.05%)

17:52
08/16/17
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17:52
Earnings
NetApp sees low double digit EPS growth for FY18, consensus $3.03 »

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SFST

Southern First Bancshares

$36.00

0.05 (0.14%)

17:50
08/16/17
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Hot Stocks
Southern First Bancshares CFO Michael Dowling sells 5,850 shares »

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BXE

Bellatrix Exploration

$2.40

-0.03 (-1.23%)

17:49
08/16/17
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Hot Stocks
Bellatrix Exploration regains NYSE minimum price compliance »

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NTAP

NetApp

$42.41

0.44 (1.05%)

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NetApp says headwind for services revenue to decrease in coming quarters »

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ACHN

Achillion

$4.88

-0.12 (-2.40%)

17:45
08/16/17
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Conference/Events
Achillion management to meet with William Blair »

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BCOR

Blucora

$23.35

0.1 (0.43%)

, BBOX

Black Box

$3.75

-0.25 (-6.25%)

17:35
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Hot Stocks
On The Fly: After Hours Movers »

HIGHER: Blucora (BCOR),…

BCOR

Blucora

$23.35

0.1 (0.43%)

BBOX

Black Box

$3.75

-0.25 (-6.25%)

BGG

Briggs & Stratton

$24.09

0.29 (1.22%)

LB

L Brands

$39.55

0.5 (1.28%)

VIPS

Vipshop

$11.10

-0.07 (-0.63%)

SPTN

SpartanNash

$25.96

0.07 (0.27%)

SNPS

Synopsys

$79.09

0.86 (1.10%)

CSCO

Cisco

$32.34

0.25 (0.78%)

NTAP

NetApp

$42.41

0.44 (1.05%)

LAKE

Lakeland Industries

$15.65

-0.25 (-1.57%)

GCP

GCP Applied Technologies

$28.75

0.1 (0.35%)

FNGN

Financial Engines

$34.35

-0.1 (-0.29%)

ACHC

Acadia

$51.68

-0.33 (-0.63%)

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ANDX

Andeavor Logistics

$46.94

0.12 (0.26%)

, WNRL

Western Refining Logistics

$24.25

0.1 (0.41%)

17:26
08/16/17
08/16
17:26
08/16/17
17:26
Upgrade
Andeavor Logistics, Western Refining Logistics rating change at MUFG »

Andeavor Logistics…

ANDX

Andeavor Logistics

$46.94

0.12 (0.26%)

WNRL

Western Refining Logistics

$24.25

0.1 (0.41%)

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GD

General Dynamics

$200.61

1.12 (0.56%)

17:22
08/16/17
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Hot Stocks
General Dynamics awarded $115.3M government contract modification »

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BLVD

Boulevard Acquisition

$10.04

-0.01 (-0.10%)

17:17
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Breaking Hot Stocks news story on Boulevard Acquisition »

Glazer Capital reports…

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FMBH

First Mid-Illinois Bancshares

$34.85

-0.33 (-0.94%)

17:17
08/16/17
08/16
17:17
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17:17
Syndicate
First Mid-Illinois Bancshares files to sell $20M of common stock 'at-the-market' »

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NCOM

National Commerce

$39.55

0.1 (0.25%)

17:16
08/16/17
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Hot Stocks
National Commerce, FirstAtlantic Financial sign definitive merger agreement »

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AMGN

Amgen

$171.39

1.35 (0.79%)

17:13
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Hot Stocks
Amgen: NEJM publishes results from Repatha cognitive function trial »

Amgen announced that the…

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