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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
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.
01/17/17
LEHM
01/17/17
DOWNGRADE
LEHM
Underweight
Chiasma downgraded to Underweight from Equal Weight at Barclays

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TSLA

Tesla

$315.05

2.55 (0.82%)

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GT

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HMC

Honda

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0.02 (0.06%)

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PG

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BHGE

Baker Hughes

$30.91

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, GE

General Electric

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GE

General Electric

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CSCO

Cisco

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IBM

IBM

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GE

General Electric

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GE

General Electric

$18.21

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Risk remains after GE dividend cut, Barron's says »

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TWX

Time Warner

$88.72

0.71 (0.81%)

, T

AT&T

$34.51

-0.01 (-0.03%)

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TWX

Time Warner

$88.72

0.71 (0.81%)

T

AT&T

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NYT

New York Times

$17.65

0.05 (0.28%)

TEX

Terex

$44.82

0.8 (1.82%)

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TPIC

TPI Composites

$19.06

-0.97 (-4.84%)

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TPI Composites to host investor day »

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SYNA

Synaptics

$38.21

0.57 (1.51%)

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Synaptics management to meet with KeyBanc »

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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 »

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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%)

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TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

, LMOS

Lumos Networks

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Tactile Systems

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Lumos Networks

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IVR

Invesco Mortgage

$17.36

0.07 (0.40%)

, MKSI

MKS Instruments

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-0.35 (-0.34%)

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IVR

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$17.36

0.07 (0.40%)

MKSI

MKS Instruments

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-0.35 (-0.34%)

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MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

, BRCD

Brocade

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MKS Instruments to replace Brocade in S&P 400 at open on 11/22 »

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MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

BRCD

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AVGO

Broadcom

$271.86

-0.25 (-0.09%)

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UQM

UQM Technologies

$1.18

0.015 (1.29%)

17:24
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GS

Goldman Sachs

$238.02

-1.35 (-0.56%)

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VICL

Vical

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LGND

Ligand

$140.31

-1.4 (-0.99%)

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Ligand director sells 5,000 common shares »

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LGND

Ligand

$140.31

-1.4 (-0.99%)

17:17
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Ligand CFO sells 6,559 common shares »

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LGND

Ligand

$140.31

-1.4 (-0.99%)

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Ligand CEO sells 5,269 common shares »

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MBI

MBIA

$9.01

0.13 (1.46%)

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RBCN

Rubicon

$8.07

0.1218 (1.53%)

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Breaking Hot Stocks news story on Rubicon »

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