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FOLD

Amicus

$13.28

-0.39 (-2.85%)

06:05
09/13/17
09/13
06:05
09/13/17
06:05

Amicus: Phase 3 SD-101 study did not meet primary, secondary endpoints

Amicus Therapeutics reported that top-line data from the randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of the novel topical wound-healing agent SD-101 did not meet the primary endpoints or secondary endpoints in participants with epidermolysis bullosa. The Phase 3 ESSENCE study randomized 169 participants with a documented diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz epidermolysis bullosa to SD-101 (n=82) or placebo (n=87) during a three-month primary treatment period. SD-101 did not show a statistically significant difference from placebo in the intent to treat population (n=169). The first primary endpoint, the time to target wound closure within 3 months, was not different between groups (Hazard ratio=1.004, p=0.985).1 The second primary endpoint, the percentage of patients achieving target wound closure by month 3, was also not different between groups (49% SD-101; 54% placebo; p=0.390).2 Similarly, the secondary endpoints did not reach statistical significance versus placebo. Encouraging trends in wound closure were observed in certain sub-populations. Treatment-emergent adverse events were similar across both the SD-101 and placebo groups. The most common TEAEs were nasopharyngitis, pruritis, and pyrexia. Amicus plans to further analyze and share the Phase 3 ESSENCE results with key stakeholders in the epidermolysis bullosa community including physicians, patient organizations and regulators. In the interim, in consultation with their physicians, participants in the ongoing extension studies (SD-004 and -006) will have the opportunity to continue being treated with SD-101. Based on these top-line data Amicus has no current plans to invest in any additional clinical studies or commercial preparation activities for SD-101.

FOLD Amicus
$13.28

-0.39 (-2.85%)

06/05/17
JPMS
06/05/17
NO CHANGE
Target $13
JPMS
Overweight
Amicus shares can double on positive zorblisa data, says JPMorgan
JPMorgan analyst Anupam Rama believes investor sentiment remains very low on Amicus Therapeutics' Phase 3 readout of zorblisa. The Phase 3 Essence data for the treatment of epidermolysis bullosa are expected in Q3. The trial is "high-risk/high-reward," Rama tells investors in a research note. The analyst says he's taking a "very conservative" approach for zorblisa with $300M in peak sales and a 40% probability of success. Rama believes the stock at current levels reflects no value for zorblisa. On positive data, Amicus shares have the potential to double, Rama writes. On negative data, he sees only "sentiment based" downside of 5%-15%. The analyst keeps an Overweight rating on Amicus with a $13 price target.
07/11/17
JPMS
07/11/17
NO CHANGE
JPMS
Overweight
Amicus could be up 15%-20% on today's news, says JPMorgan
JPMorgan analyst Anupam Rama believes shares of Amicus Therapeutics could be up 15%-20% today on news of the FDA confirming that the regulatory filing for migalastat for the treatment of Fabry can now be submitted. The stock in premarket trading is up 31% to $13.45. The analyst estimates that a U.S. launch of migalastat is now moved up by two years. Rama has an Overweight rating on Amicus.
07/11/17
COWN
07/11/17
NO CHANGE
Target $16
COWN
Outperform
Amicus price target raised to $16 from $10 at Cowen
08/17/17
JPMS
08/17/17
NO CHANGE
JPMS
JPMorgan lists top SMID Biotechnology picks following Q2 results
Analysts at JPMorgan continue think selectively remains important in the small-to-mid cap Biotechnology space. The analysts listed their favorite ideas in "five key buckets." Amicus (FOLD) is the top long-term pick, Ironwood (IRWD) is the top pick among relative underperformers, Otonomy (OTIC) is the top play for a clinical/binary event, Sarepta (SRPT) is the name to take advantage of the recent share weakness, and Ignyta (RXDX) is the "underfollowed/undervalued" favorite, according to JPMorgan's Biotech team.

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NVS

Novartis

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Comcast

$42.44

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General Electric

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United Technologies

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Rockwell Automation

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Northern Trust

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Grainger

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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

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Xperi to hold a conference call »

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MDR

McDermott

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McDermott rating change at KeyBanc »

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Bombardier

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

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Bombardier

ERJ

Embraer

$24.13

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BA

Boeing

$335.59

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DAL

Delta Air Lines

$59.93

-0.2 (-0.33%)

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GSBC

Great Southern Bancorp

$52.00

0.45 (0.87%)

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Great Southern Bancorp reports preliminary Q4 EPS 86c, consnesus 83c »

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UUUU

Energy Fuels

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

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RBS

RBS

$8.46

-0.02 (-0.24%)

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RBS plans to leave London headquarters by end of 2019, Reuters reports »

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TROX

Tronox

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Tronox files lawsuit to prevent FTC from blocking proposed Cristal acquisition »

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UBNK

United Financial

$17.92

-0.03 (-0.17%)

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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

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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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SPDR S&P 500 ETF Trust

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S&P 500

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Federal Reserve Bank of Chicago President participates in a discussion »

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HESM

Hess Midstream Partners

$21.75

0.45 (2.11%)

17:46
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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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TSYS

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Cerus

$4.33

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NTIP

Network-1 Technologies

$2.60

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GOOG

Alphabet

$1,169.97

14.16 (1.23%)

GOOGL

Alphabet Class A

$1,176.17

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QGEN

Qiagen

$33.55

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SIRI

SiriusXM

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VLO

Valero

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UAL

United Continental

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NAVI

Navient

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CREE

Cree

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COF

Capital One

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TXN

Texas Instruments

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PBYI

Puma Biotechnology

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SIGM

Sigma Designs

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FPRX

Five Prime

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RCKT

Rocket Pharmaceuticals

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TK

Teekay Corp.

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SBBP

Strongbridge Biopharma

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UAL

United Continental

$77.97

1.11 (1.44%)

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

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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
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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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Initiation
MongoDB initiated at Nomura Instinet »

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UAL

United Continental

$77.97

1.1 (1.43%)

17:19
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17:19
Hot Stocks
Breaking Hot Stocks news story on United Continental »

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UAL

United Continental

$77.97

1.1 (1.43%)

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

United sees FY18 CASM…

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