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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

KPLUF

K+S

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AMZN

Amazon.com

$990.33

13.55 (1.39%)

, WFM

Whole Foods

$42.25

-0.31 (-0.73%)

12:06
06/29/17
06/29
12:06
06/29/17
12:06
Conference/Events
Deutsche Bank tech/food & retail analysts hold analyst/industry conference call »

Technology Analyst…

AMZN

Amazon.com

$990.33

13.55 (1.39%)

WFM

Whole Foods

$42.25

-0.31 (-0.73%)

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BDRBF

Bombardier

$1.87

0.039 (2.13%)

12:03
06/29/17
06/29
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12:03
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Bombardier Transportation reaches agreement on reorientation in Germany »

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VIX

Volatility Index S&P 500 Options

12:00
06/29/17
06/29
12:00
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12:00
Options
Active trading in VIX pit as the index spikes »

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CRM

Salesforce

$86.00

-2.09 (-2.37%)

11:55
06/29/17
06/29
11:55
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11:55
Options
Salesforce put volume heavy and directionally bearish »

Bearish flow noted in…

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11:55
06/29/17
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11:55
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11:55
General news
Treasury Action: the long end of the curve remains weaker »

Treasury Action: the long…

NFX

Newfield Exploration

$28.45

0.89 (3.23%)

11:45
06/29/17
06/29
11:45
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11:45
Options
Newfield Exploration call volume above normal and directionally bullish »

Bullish option flow…

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  • 02

    Aug

XLK

Technology Select Sector SPDR

$54.81

-0.96 (-1.72%)

, XLF

Financial Select Sector

$24.79

0.27 (1.10%)

11:38
06/29/17
06/29
11:38
06/29/17
11:38
Technical Analysis
Technical View: S&P 500 breaks 2420, bounces fractionally »

The S&P 500 (SPX)…

XLK

Technology Select Sector SPDR

$54.81

-0.96 (-1.72%)

XLF

Financial Select Sector

$24.79

0.27 (1.10%)

SPY

SPDR S&P 500 ETF Trust

$241.95

-1.54 (-0.63%)

SPX

S&P 500

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JPM

JPMorgan

$91.56

1.7362 (1.93%)

11:30
06/29/17
06/29
11:30
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11:30
Options
Bullish option play in JP Morgan as shares rally »

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  • 14

    Jul

  • 12

    Oct

  • 13

    Apr

  • 14

    Jul

  • 12

    Oct

11:25
06/29/17
06/29
11:25
06/29/17
11:25
General news
Treasury announced a $72 B 3- and 6-month bill auction for Monday »

Treasury announced a $72…

INFO

IHS Markit

$45.05

-0.32 (-0.71%)

11:25
06/29/17
06/29
11:25
06/29/17
11:25
Conference/Events
The National Economists Club to hold a luncheon meeting Symbol changed to INFO IHS Markit »

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  • 29

    Jun

QVCA

QVC Group

$24.61

0.1 (0.41%)

, QVCB

QVC Group

11:25
06/29/17
06/29
11:25
06/29/17
11:25
Conference/Events
FBN Securities media analyst to hold a luncheon meeting »

Media Analyst Routh…

QVCA

QVC Group

$24.61

0.1 (0.41%)

QVCB

QVC Group

LVNTA

Liberty Ventures

$52.69

1.21 (2.35%)

GNCMA

General Communications

$36.81

0.97 (2.71%)

03/08/13
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  • 29

    Jun

  • 10

    Jul

ALRN

Aileron Therapeutics

11:23
06/29/17
06/29
11:23
06/29/17
11:23
Syndicate
Breaking Syndicate news story on Aileron Therapeutics »

Aileron Therapeutics…

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  • 29

    Jun

SHLD

Sears

$8.01

0.29 (3.76%)

11:22
06/29/17
06/29
11:22
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11:22
Hot Stocks
Breaking Hot Stocks news story on Sears »

Returning to…

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SHLD

Sears

$8.01

0.29 (3.76%)

11:20
06/29/17
06/29
11:20
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11:20
Hot Stocks
Breaking Hot Stocks news story on Sears »

Berkowitz says Fairholme…

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ABBV

AbbVie

$72.91

-0.01 (-0.01%)

11:20
06/29/17
06/29
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11:20
Options
Abbvie attracts an opening call write »

Abbvie attracts an…

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SHLD

Sears

$8.01

0.29 (3.76%)

11:17
06/29/17
06/29
11:17
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11:17
Hot Stocks
Real estate value the 'margin of safety' in Sears investment, Berkowitz says »

Bruce Berkowitz,…

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$NSD

NASDAQ Market Internals

11:17
06/29/17
06/29
11:17
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11:17
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NASDAQ market internals summary »

Volume is above average…

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SHLD

Sears

$8.01

0.29 (3.76%)

11:16
06/29/17
06/29
11:16
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11:16
Hot Stocks
Berkowitz sees Sears net asset value at $90 per share »

Bruce Berkowitz of…

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$NYE

NYSE Market Internals

11:16
06/29/17
06/29
11:16
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11:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

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GOOGL

Alphabet Class A

$961.01

12.92 (1.36%)

11:14
06/29/17
06/29
11:14
06/29/17
11:14
Technical Analysis
Technical View: Alphabet Class A has an active bearish pattern »

A bearish head and…

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BDRBF

Bombardier

$1.87

0.039 (2.13%)

11:13
06/29/17
06/29
11:13
06/29/17
11:13
Hot Stocks
Bombardier says Transportation restructuring costs included in previous guidance »

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11:11
06/29/17
06/29
11:11
06/29/17
11:11
General news
4-Week Bill Announcement Offering Amount data reported »

4-Week Bill Announcement…

11:11
06/29/17
06/29
11:11
06/29/17
11:11
General news
6-Month Bill Announcement Offering Amount data reported »

6-Month Bill Announcement…

11:11
06/29/17
06/29
11:11
06/29/17
11:11
General news
3-Month Bill Announcement Offering Amount data reported »

3-Month Bill Announcement…

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