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OMER

Omeros

$14.09

-0.155 (-1.09%)

10:36
11/10/17
11/10
10:36
11/10/17
10:36

Omeros jumps after detailing FDA meeting on IgA nephropathy program

Shares of Omeros (OMER) have surged after the company last night reported financial results for the third quarter and announced recent highlights and developments. Omeros said that it met with the FDA in follow-up to the FDA's granting breakthrough designation for OMS721 in IgA nephropathy to discuss Phase 3 trial design. "The Agency's meeting minutes make clear that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint. Depending on the size of the effect on proteinuria, either full approval or accelerated approval is possible. If full approval is granted based on reduction in proteinuria, estimated glomerular filtration rate will be followed as part of the safety assessment. Any effect of OMS721 on eGFR is likely to result in additional label claims for the product. If, based on the effect on proteinuria, accelerated rather than full approval is granted, marketing of OMS721 would be allowed during which time confirmatory data on long-term effects of OMS721 on eGFR would be collected. These eGFR data, if satisfactory, would then form the basis for full approval," the company stated. Gregory Demopulos, chairman and chief executive officer of Omeros, added, "We have also made substantial progress across our OMS721 programs - in addition to our Phase 3 aHUS program, we have a clear roadmap for the Phase 3 IgA nephropathy trial, including FDA confirmation of proteinuria as the primary efficacy endpoint, and compelling data to support our advancing to a Phase 3 program in stem cell transplant-associated TMA." In morning trading, Omeros shares are up $4.35, or 31%, to $18.44.

OMER Omeros
$14.09

-0.155 (-1.09%)

11/08/17
HCWC
11/08/17
INITIATION
Target $30
HCWC
Buy
Omeros initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju started Omeros with a Buy rating and $30 price target. The analyst says the company is undervalued based on its sole marketed ophthalmology drug alone, while its pipeline provides a "bonus."
11/02/17
COWN
11/02/17
DOWNGRADE
COWN
Market Perform
Omeros downgraded to Market Perform from Outperform at Cowen
05/11/17
CANT
05/11/17
DOWNGRADE
Target $15
CANT
Neutral
Omeros downgraded to Neutral from Overweight at Cantor
Cantor analyst Elemer Piros downgraded Omeros to Neutral and lowered its price target to $15 from $21 following the slightly weaker than expected Q1 report. The analyst has tempered his estimates for the US commercial ramp in peak market penetration to 25% from 30% and views shares as fully valued.

TODAY'S FREE FLY STORIES

SYNA

Synaptics

$38.21

0.57 (1.51%)

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  • 18

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MKSI

MKS Instruments

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Brocade

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Lumos Networks

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WGL

WGL Holdings

$84.32

-0.14 (-0.17%)

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TCMD

Tactile Systems

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  • 28

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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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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

17:55
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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%)

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AVGO

Broadcom

$271.86

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  • 06

    Dec

UQM

UQM Technologies

$1.18

0.015 (1.29%)

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

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GS

Goldman Sachs

$238.02

-1.35 (-0.56%)

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

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VICL

Vical

$1.94

-0.02 (-1.02%)

17:18
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LGND

Ligand

$140.31

-1.4 (-0.99%)

17:18
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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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Breaking Hot Stocks news story on MBIA »

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RBCN

Rubicon

$8.07

0.1218 (1.53%)

17:03
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ANCB

Anchor Bancorp

$24.75

-0.1 (-0.40%)

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

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GIFI

Gulf Island Fabrication

$12.30

-0.1 (-0.81%)

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Breaking Syndicate news story on Gulf Island Fabrication »

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MPB

Mid Penn Bancorp

$31.09

0.59 (1.93%)

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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
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Callidus Software initiated at First Analysis »

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GIFI

Gulf Island Fabrication

$12.30

-0.1 (-0.81%)

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Breaking Hot Stocks news story on Gulf Island Fabrication »

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GE

General Electric

$18.21

-0.04 (-0.22%)

16:42
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General Electric CEO acquires 60,000 common shares »

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NRE

Northstar Realty Europe

$14.20

0.05 (0.35%)

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

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  • 28

    Nov

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  • 30

    Nov

FHN

First Horizon

$18.40

0.1 (0.55%)

, CBF

Capital Bank

$39.95

0.25 (0.63%)

16:33
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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%)

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LII

Lennox

$194.25

-0.75 (-0.38%)

16:32
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Lennox executive sells 2,500 common shares »

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  • 28

    Nov

TBNK

Territorial Bancorp

$30.99

0.21 (0.68%)

16:31
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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
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Triton International's Hanau sells 10,000 common shares »

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