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FOLD

Amicus

$8.32

-0.58 (-6.52%)

17:17
11/28/16
11/28
17:17
11/28/16
17:17

Amicus to pursue more migalastat data as FDA rules out quick path

Amicus Therapeutics (FOLD) plunged in after-hours trading after ruling out accelerated approval for its migalastat product and confirming the need for additional data. AMICUS SAYS MORE DATA NEEDED: In a press release shortly after market close, Amicus detailed its "planned regulatory pathway to collect additional data to support full approval" of migalastat: "Following several collaborative discussions with the FDA, including the receipt of final written minutes from an in-person Type B meeting, the company plans to collect additional data on gastrointestinal symptoms in Fabry patients who have an amenable mutation. Key elements of the additional data generation... may include: Randomized, 12-month, placebo-controlled pivotal 'cross-over' study in treatment naive Fabry patients who have an amenable mutation and GI symptoms. Crossover study design provides sufficient powering with a small number of patients, ~35 patients planned. Primary endpoint to assess diarrhea based upon established FDA irritable bowel syndrome guidance." Amicus noted it is working with the FDA to finalize the clinical protocol and plans to initiate enrollment in 2017, with data expected in 2019. The company also disclosed that "during its review of the briefing document submitted and in discussions with Amicus, the FDA acknowledged that significant unmet medical need exists in Fabry disease. The agency also indicated that kidney globotriaosylceramide is currently not considered a basis for an accelerated approval under Subpart H." Weighing in on the news, CEO John Crowley stated, "While we believe that the totality of the data from our studies with migalastat support the submission of a new drug application today, we acknowledge the FDA's position that accelerated approval based on kidney GL-3 reduction is not currently an option... FDA has been flexible in allowing a crossover design and in our use of established GI endpoints to measure clinical benefit in Fabry patients. We are fully committed to the additional work necessary to move migalastat toward approval." PRICE ACTION: Shares of Amicus are down 27.76% to $6.01 in post-market trading.

FOLD Amicus
$8.32

-0.58 (-6.52%)

06/14/16
LEER
06/14/16
NO CHANGE
Target $19
LEER
Outperform
Protalix development encouraging for Amicus Galafold, says Leerink
Leerink analyst Joseph Schwartz is "incrementally encouraged" by the news that Protalix (PLX) reached an agreement with the FDA to advance its Fabry ERT into a pivotal trial, just before Amicus' (FOLD) meeting with the agency to discuss a regulatory path for its Galafold. Amicus was poised to emphasize non-renal data in the upcoming FDA meeting, but now the company has "another way to win" by using renal data, the analyst tells investors in a research note. Schwartz now assigns a 33% probability for Galafold. The analyst reiterates an Outperform rating on Amicus' stock and raised his price target on the shares to $19 from $17.
07/20/16
JPMS
07/20/16
NO CHANGE
Target $13
JPMS
Overweight
Amicus risk/reward 'compelling' at current levels, says JPMorgan
JPMorgan analyst Anupam Rama views the risk/reward for shares of Amicus Therapeutics at current levels as "compelling." After declining 39% year-to-date, Amicus is essentially only pricing in outside the U.S. Galafold sales in Fabry disease plus cash, Rama tells investors in a research note. Very little credit is being given to the company's U.S. migalastat, Zorblisa or the Pompe program, which all have events in the second half of 2016, the analyst contends. Rama thinks only one of the three need to hit for the stock to trade "materially higher," with upside ranging from 20%-100%-plus on a single success, and "meaningfully more upside" potential on multiple positive updates. Rama reiterates an Overweight rating on Amicus with a $13 price target.
08/22/16
GSCO
08/22/16
NO CHANGE
GSCO
Goldman lists companies to be in focus after Medivation deal
After Pfizer (PFE) announced it has agreed to acquire Medivation (MDVN) for $81.50 per share in cash, Goldman Sachs analyst Salveen Richter said he expects a focus on other commercial small-to-mid-cap cancer companies, including Incyte (INCY), Seattle Genetics (SGEN), ARIAD (ARIA) and Exelixis (EXEL). Also noting that Sanofi (SNY), which was pursuing Medivation, has recently suggested an interest in a rare disease transaction up to potentially as large as $20B, he would expect rare disease companies of that size - such as BioMarin (BMRN), Amicus (FOLD) and Ultragenyx (RARE) - to be in focus as well.
10/07/16
GSCO
10/07/16
NO CHANGE
GSCO
Smid-cap Biotech sector upgraded to Attractive from Neutral at Goldman
Goldman analyst Salveen Richter upgraded the Smid-cap biotechnology to Attractive and said he favors and companies with near-term pipeline data or regulatory events where he has conviction.Names he recommends are Buy rated BioMarin (BMRN), bluebird bio (BLUE), GW Pharma (GWPH), Incyte (INCY), Kite (KITE), and Sage (SAGE).

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BMY

Bristol-Myers

$62.28

0.45 (0.73%)

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EXEL

Exelixis

$28.00

0.14 (0.50%)

, RHHBY

Roche

$30.69

0.18 (0.59%)

15:22
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Exelixis presents updated results from Phase 1b clinical trial in CRC »

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EXEL

Exelixis

$28.00

0.14 (0.50%)

RHHBY

Roche

$30.69

0.18 (0.59%)

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ARRY

Array BioPharma

$13.14

0.26 (2.02%)

15:17
01/20/18
01/20
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SO

Southern Company

$44.44

-0.46 (-1.02%)

15:13
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15:13
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Southern Company accelerates restoration efforts in Puerto Rico »

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TECK

Teck Resources

$29.43

0.19 (0.65%)

15:10
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Teck Resources announces Elkview incident »

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TWTR

Twitter

$23.66

-0.38 (-1.58%)

14:03
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14:03
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Twitter begins notifying users exposed to Russian propaganda during elections »

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SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

, SPX

S&P 500

13:58
01/20/18
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13:58
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13:58
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Government shuts down on anniversary of Trump presidency, Reuters reports »

President's Trump…

SPY

SPDR S&P 500 ETF Trust

$280.41

1.27 (0.45%)

SPX

S&P 500

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FB

Facebook

$181.29

1.49 (0.83%)

, NYT

New York Times

$21.90

1.7 (8.42%)

13:48
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13:48
Periodicals
NY Times stock jumps after Facebook's announcement, Recode reports »

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FB

Facebook

$181.29

1.49 (0.83%)

NYT

New York Times

$21.90

1.7 (8.42%)

NWSA

News Corp.

$17.22

0.21 (1.23%)

FOXA

21st Century Fox

$36.65

0.47 (1.30%)

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WMT

Walmart

$104.59

0.29 (0.28%)

13:36
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13:36
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Still time to shop Walmart shares as company makes changes, Barron's says »

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AAPL

Apple

$178.46

-0.8 (-0.45%)

, NFLX

Netflix

$220.46

0.13 (0.06%)

08:59
01/20/18
01/20
08:59
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08:59
Periodicals
Netflix among likely candidates for an Apple purchase, Barron's says »

Especially for tech…

AAPL

Apple

$178.46

-0.8 (-0.45%)

NFLX

Netflix

$220.46

0.13 (0.06%)

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BA

Boeing

$337.73

-2.43 (-0.71%)

08:50
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08:50
Periodicals
Boeing not a sell just yet, Barron's says »

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AAPL

Apple

$178.46

-0.8 (-0.45%)

, EADSY

Airbus

$28.43

0.755 (2.73%)

08:24
01/20/18
01/20
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08:24
Hot Stocks
Week in review: How Trump's policies moved stocks »

Catch up on the top…

AAPL

Apple

$178.46

-0.8 (-0.45%)

EADSY

Airbus

$28.43

0.755 (2.73%)

BA

Boeing

$337.73

-2.43 (-0.71%)

VZ

Verizon

$51.91

0.36 (0.70%)

NYT

New York Times

$21.90

1.7 (8.42%)

TWX

Time Warner

$93.36

0.39 (0.42%)

DIS

Disney

$110.59

0.17 (0.15%)

TIME

Time Inc.

$18.55

0.05 (0.27%)

AMZN

Amazon.com

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1.26 (0.10%)

BAC

Bank of America

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Goldman Sachs

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BK

BNY Mellon

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1.26 (2.28%)

WLKP

Westlake Chemical Partners

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MON

Monsanto

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1.8 (1.51%)

DLTR

Dollar Tree

$114.73

1.83 (1.62%)

CE

Celanese

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1.93 (1.74%)

LYB

LyondellBasell

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3.03 (2.59%)

TSE

Trinseo

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2.2 (2.85%)

EYE

National Vision

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ETFC

E-Trade

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LPL Financial

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AMTD

TD Ameritrade

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SCHW

Charles Schwab

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ADS

Alliance Data

$261.82

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Fiserv

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FleetCor

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3.4 (1.67%)

HAWK

Blackhawk

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0.1 (0.22%)

MTZ

MasTec

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CME

CME Group

$154.28

2.07 (1.36%)

, GS

Goldman Sachs

$256.12

5.15 (2.05%)

04:55
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Conference/Events
American Bar Association to hold annual meeting »

Derivatives & Futures…

CME

CME Group

$154.28

2.07 (1.36%)

GS

Goldman Sachs

$256.12

5.15 (2.05%)

BP

BP

$42.40

-0.5 (-1.17%)

C

Citi

$78.30

0.91 (1.18%)

BAC

Bank of America

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0.24 (0.76%)

CS

Credit Suisse

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0.13 (0.69%)

CRL

Charles River

$107.89

1.22 (1.14%)

MS

Morgan Stanley

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1.62 (2.90%)

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AMGN

Amgen

$189.28

1.69 (0.90%)

, BAYRY

Bayer

$32.05

0.235 (0.74%)

04:55
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Conference/Events
American Society of Clinical Oncology to hold a symposium »

2018 ASCO…

AMGN

Amgen

$189.28

1.69 (0.90%)

BAYRY

Bayer

$32.05

0.235 (0.74%)

BLRX

BioLineRx

$1.09

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BMY

Bristol-Myers

$62.28

0.45 (0.73%)

CELG

Celgene

$102.65

0.93 (0.91%)

DNA

Bought by RHHBY

ESALY

Eisai

$56.88

0.115 (0.20%)

EXEL

Exelixis

$28.00

0.14 (0.50%)

HALO

Halozyme

$17.98

0.13 (0.73%)

INCY

Incyte

$93.16

1.24 (1.35%)

IPSEY

Ipsen

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0.75 (2.21%)

LXRX

Lexicon

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0.2 (1.95%)

MGNX

MacroGenics

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0.3 (1.59%)

MRK

Merck

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NVS

Novartis

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0.53 (0.61%)

SNY

Sanofi

$44.60

0.09 (0.20%)

ONCY

Oncolytics

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WLFC

Willis Lease

$26.66

0.05 (0.19%)

18:59
01/19/18
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Willis Lease announces $1,000 bonus for employees »

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DPS

Dr Pepper Snapple

$96.35

1.03 (1.08%)

18:13
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Dr Pepper to become official sponsor of esports team TSM »

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RCII

Rent-A-Center

$11.70

0.09 (0.78%)

17:53
01/19/18
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Vintage Capital in standstill pact with Rent-A-Center »

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AR

Antero Resources

$18.74

-0.59 (-3.05%)

17:44
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17:44
Recommendations
Antero Resources analyst commentary at MUFG »

Antero Resources price…

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T

AT&T

$37.21

0.06 (0.16%)

, TWX

Time Warner

$93.36

0.39 (0.42%)

17:44
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01/19
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17:44
Periodicals
AT&T requesting docs from companies in Time Warner deal hearing, Reuters says »

AT&T (T) is…

T

AT&T

$37.21

0.06 (0.16%)

TWX

Time Warner

$93.36

0.39 (0.42%)

VZ

Verizon

$51.91

0.36 (0.70%)

CMCSA

Comcast

$42.50

0.65 (1.55%)

CMCSK

Comcast

DISH

Dish

$45.26

0.1 (0.22%)

CHTR

Charter

$366.05

0.8 (0.22%)

DIS

Disney

$110.59

0.17 (0.15%)

VIA

Viacom

$39.20

-0.5 (-1.26%)

VIAB

Viacom

$33.36

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GRPN

Groupon

$5.57

0.46 (9.00%)

17:44
01/19/18
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Groupon announces Chief Product Officer Jay Sullivan resigns »

On January 17, Jay…

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CELG

Celgene

$102.65

0.93 (0.91%)

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Celgene's Abraxane exceeds primary endpoint target in pancreatic cancer trial »

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VALU

Value Line

$19.60

0.3 (1.55%)

17:40
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01/19
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17:40
Hot Stocks
Value Line reaffirms $3M stock repurchase program »

The Board of Directors…

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VALU

Value Line

$19.60

0.3 (1.55%)

17:39
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Value Line declares special dividend of 20c per share »

Payable on March 9 to…

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ZEAL

Zealand Pharma

$15.05

-0.78 (-4.93%)

17:34
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17:34
Hot Stocks
Zealand Pharma: FDA approves IND for Phase 3 trials of dasiglucagon in CHI »

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GNMSF

Genmab

$190.75

2.75 (1.46%)

, JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

17:29
01/19/18
01/19
17:29
01/19/18
17:29
Hot Stocks
Genmab says FDA grants priority review for daratumumab »

Genmab (GNMSF) announced…

GNMSF

Genmab

$190.75

2.75 (1.46%)

JNJ

Johnson & Johnson

$147.36

0.44 (0.30%)

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