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RPRX

Repros Therapeutics

$2.07

-0.02 (-0.96%)

10:37
10/05/16
10/05
10:37
10/05/16
10:37

Repros Therapeutics announces acceptance of dossier for enclomiphene in Europe

Repros Therapeutics announced that it has received confirmation of acceptance of its September 12, 2016 filing for enclomiphene in the treatment of secondary hypogonadism in Europe. Notes analogous to acceptance of an NDA by U.S. Food and Drug Administration. Says responses expected by end of January 2017. The MAA was submitted to the European Medicines Agency by Renable Pharma Limited, the UK subsidiary of Repros. As has been described in previous communications, the typical time from submission to authorization of a medicinal product through the EMA's centralized procedure is 13-16 months and culminates in one authorization being obtained which is valid in all European Union and European Economic Area countries, i.e. 31 in total. The centralized procedure allows for a pan-EU review of the data, led by the Rapporteur's and Co-Rapporteur's assessment teams, and is governed by set timelines; therefore the review time is well defined. In this context, the Company expects to receive all questions relating to the application by the end of January 2017.

RPRX Repros Therapeutics
$2.07

-0.02 (-0.96%)

10/30/15
BMUR
10/30/15
DOWNGRADE
BMUR
Hold
Repros Therapeutics downgraded to Hold from Buy at Brean Capital
Brean Capital analyst Jonathan Aschoff downgraded Repros Therapeutics to Hold after the FDA cancelled its advisory committee meeting to review the company's most advanced candidate, enclomiphene. Aschoff cites the regulatory setback and a lack of clarity on a path forward for the drug.
10/30/15
BOFA
10/30/15
DOWNGRADE
BOFA
Underperform
Repros Therapeutics downgraded to Underperform from Neutral at BofA/Merrill
BofA/Merrill downgraded Repros Therapeutics to Underperform from Buy after the FDA cancelled its advisory committee meeting to review the company's most advanced candidate, enclomiphene.
10/30/15
LTCO
10/30/15
DOWNGRADE
LTCO
Neutral
Repros Therapeutics downgraded to Neutral from Buy at Ladenburg
Ladenburg analyst Matthew Kaplan downgraded Repros Therapeutics to Neutral after the company announced the FDA cancellation of the enclomiphene committee meeting planned for November 3. The analyst sees a "significant level of uncertainty" with respect to the regulatory path forward.
10/30/15
10/30/15
DOWNGRADE

On The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: Altria Group (MO) downgraded to Market Perform at Cowen... Arch Capital (ACGL) downgraded to Underperform from Neutral at BofA/Merrill... Autodesk (ADSK) downgraded to Mixed from Positive at OTR Global... BRF S.A. (BRFS) downgraded to Underperform from Buy at BofA/Merrill... Bloomin' Brands (BLMN) downgraded to Mixed from Positive at OTR Global... BorgWarner (BWA) downgraded to Sector Perform from Outperform at RBC Capital... Boston Beer (SAM) downgraded to Outperform from Buy at CLSA... Bottomline Technologies (EPAY) downgraded to Hold from Buy at Craig-Hallum... Brinker (EAT) downgraded to Hold from Buy at Argus... Calix (CALX) downgraded to Hold from Buy at Jefferies... Chart Industries (GTLS) downgraded to Hold from Buy at Lake Street... Control4 (CTRL) downgraded to Hold from Buy at Needham... Cumulus Media (CMLS) downgraded to Sector Perform from Outperform at RBC Capital... DigitalGlobe (DGI) downgraded to Market Perform from Outperform at Raymond James... DreamWorks (DWA) downgraded to Underperform from Neutral at BofA/Merrill... EverBank (EVER) downgraded to Underperform from Buy at BofA/Merrill... Flagstar Bancorp (FBC) downgraded to Market Perform from Outperform at Keefe Bruyette... Foresight Energy (FELP) downgraded following weak results at Stifel... Goldcorp (GG) downgraded to Buy from Action List Buy at TD Securities... HeartWare (HTWR) downgraded to Neutral from Overweight at Piper Jaffray... HomeTrust (HTBI) downgraded to Market Perform from Outperform at Keefe Bruyette... Hornbeck Offshore (HOS) downgraded to Sector Perform from Outperform at Iberia... Investors Bancorp (ISBC) downgraded to Neutral from Buy at Compass Point... L-3 Communications (LLL) downgraded to Market Perform from Outperform at Cowen... MakeMyTrip (MMYT) downgraded to Hold from Buy at Deutsche Bank... Meritage Homes (MTH) downgraded to Hold from Buy at Evercore ISI... New York Community Bancorp (NYCB) downgraded to Underperform at FBR Capital... Oceaneering (OII) downgraded to Market Perform from Outperform at Cowen... Orion Engineered (OEC) downgraded to Neutral from Buy at UBS... Papa John's (PZZA) downgraded to Sector Weight from Overweight at KeyBanc... Peabody (BTU) downgraded on negative catalysts at Stifel... Peoples Bancorp (PEBO) downgraded to Outperform from Strong Buy at Raymond James... Qunar (QUNR) downgraded on Ctrip transaction at Stifel... RTI Surgical (RTIX) downgraded to Hold at Canaccord... Rayonier Advanced Materials (RYAM) downgraded to Sector Perform from Outperform at RBC Capital... Repros Therapeutics (RPRX) downgraded to Hold from Buy at Brean Capital... STMicroelectronics (STM) downgraded to Hold from Buy at Craig-Hallum... SolarCity (SCTY) downgraded to Neutral from Outperform at Baird... SolarWinds (SWI) downgraded to Hold from Buy at Jefferies... Starz (STRZA) downgraded to Underperform from Buy at CLSA... Swift Transport (SWFT) downgraded to Market Perform from Outperform at Avondale... Thermon Group (THR) downgraded to Market Perform from Outperform at William Blair... ePlus (PLUS) downgraded on valuation at Stifel.

TODAY'S FREE FLY STORIES

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NVS

Novartis

$87.21

0.21 (0.24%)

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Comcast

$42.44

-0.45 (-1.05%)

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Earnings
Notable companies reporting before tomorrow's open »

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Novartis

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NTRS

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$229.45

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CERS

Cerus

$4.33

0.14 (3.34%)

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Cerus to hold a pharmaceutical update conference call »

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XPER

Xperi

$22.85

0.35 (1.56%)

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Xperi to hold a conference call »

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MDR

McDermott

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Bombardier

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Embraer

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Bombardier invokes Embraer in Boeing trade dispute, Globe and Mail says »

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BDRBF

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ERJ

Embraer

$24.13

-0.34 (-1.39%)

BA

Boeing

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-2.41 (-0.71%)

DAL

Delta Air Lines

$59.93

-0.2 (-0.33%)

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GSBC

Great Southern Bancorp

$52.00

0.45 (0.87%)

19:01
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Earnings
Great Southern Bancorp reports preliminary Q4 EPS 86c, consnesus 83c »

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UUUU

Energy Fuels

$1.72

0.035 (2.08%)

18:48
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Hot Stocks
Energy Fuels names Mark S. Chalmers president and CEO »

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Breaking General news story  »

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RBS

RBS

$8.46

-0.02 (-0.24%)

18:10
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Periodicals
RBS plans to leave London headquarters by end of 2019, Reuters reports »

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TROX

Tronox

$21.88

0.07 (0.32%)

18:09
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Hot Stocks
Tronox files lawsuit to prevent FTC from blocking proposed Cristal acquisition »

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UBNK

United Financial

$17.92

-0.03 (-0.17%)

18:00
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Hot Stocks
United Financial reports Q4 provision for loan losses $2.3M »

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UBNK

United Financial

$17.92

-0.03 (-0.17%)

17:59
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Earnings
United Financial reports Q4 EPS with items 19c, consensus 30c »

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SPY

SPDR S&P 500 ETF Trust

$283.29

0.6 (0.21%)

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S&P 500

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Breaking General news story on SPDR S&P 500 ETF Trust, S&P 500 »

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SPY

SPDR S&P 500 ETF Trust

$283.29

0.6 (0.21%)

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S&P 500

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17:55
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Conference/Events
Federal Reserve Bank of Chicago President participates in a discussion »

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HESM

Hess Midstream Partners

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Hess Midstream Partners raises quarterly dividend 3.6% to 32.2c per unit »

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GWB

Great Western

$44.29

0.53 (1.21%)

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Great Western announces financial impact resulting from Tax Cuts and Jobs Act »

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ARAY

Accuray

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TSYS

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On The Fly: After Hours Movers »

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$1,176.17

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Qiagen

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SiriusXM

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UAL

United Continental

$77.97

1.1 (1.43%)

NAVI

Navient

$13.44

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CREE

Cree

$35.02

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COF

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Texas Instruments

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PBYI

Puma Biotechnology

$90.90

-3.05 (-3.25%)

SIGM

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FPRX

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$22.43

0.14 (0.63%)

RCKT

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TK

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$10.74

0.05 (0.47%)

SBBP

Strongbridge Biopharma

$8.70

0.25 (2.96%)

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UAL

United Continental

$77.97

1.11 (1.44%)

17:25
01/23/18
01/23
17:25
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17:25
Earnings
United Continental sees FY18 EPS $6.50-$8.50, consensus $6.97 »

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17:25
01/23/18
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17:25
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Conference/Events
The Chicago Council on Global Affairs to hold a panel discussion »

The Chicago Council on…

MULE

MuleSoft

$25.08

-0.31 (-1.22%)

17:21
01/23/18
01/23
17:21
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17:21
Initiation
MuleSoft initiated at Nomura Instinet »

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MDB

MongoDB

$28.83

0.02 (0.07%)

17:19
01/23/18
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17:19
Initiation
MongoDB initiated at Nomura Instinet »

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UAL

United Continental

$77.97

1.1 (1.43%)

17:19
01/23/18
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17:19
Hot Stocks
Breaking Hot Stocks news story on United Continental »

United sees FY19 and FY20…

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UAL

United Continental

$77.97

1.1 (1.43%)

17:18
01/23/18
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17:18
Hot Stocks
Breaking Hot Stocks news story on United Continental »

United sees FY18 CASM…

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