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ALNY

Alnylam

$128.20

-2.69 (-2.06%)

, SNY

Sanofi

$43.70

0.46 (1.06%)

07:01
12/12/17
12/12
07:01
12/12/17
07:01

Alnylam completes submission of NDA for Patisiran for hATTR amyloidosis

Alnylam Pharmaceuticals (ALNY) announced the completion of the rolling submission of a New Drug Application to the U.S. FDA for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of adults with hereditary transthyretin-mediated amyloidosis. The rolling submission began on November 15, 2017 with the nonclinical and chemistry, manufacturing and controls components submitted, and now submission of the clinical data completes the filing. Alnylam has requested priority review for the application which, if granted, could result in a six-month review process. Patisiran previously received Fast Track and Breakthrough Therapy designations from the FDA, and recently received an expanded Orphan Drug Designation for ATTR amyloidosis. Patisiran also has been granted accelerated assessment by the European Medicines Agency. Alnylam, in collaboration with Sanofi Genzyme (SNY), intends to file a Marketing Authorization Application in the European Union around year-end. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world, including certain Central and Eastern European countries of the European Union.

ALNY

Alnylam

$128.20

-2.69 (-2.06%)

SNY

Sanofi

$43.70

0.46 (1.06%)

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ALNY Alnylam
$128.20

-2.69 (-2.06%)

11/17/17
PIPR
11/17/17
NO CHANGE
Target $182
PIPR
Overweight
Piper trims Alnylam target to $182 after capital raise
Piper Jaffray analyst Edward Tenthoff trimmed his price target for Alnylam Pharmaceuticals to $182 from $188 to account for dilution from the company's issuance of 6.44M shares at $125. The company's cash position of $1.93B will allow for the patisiran launch and pipeline advancements, Tenthoff tells investors in a research note. He reiterates an Overweight rating on Alnylam.
11/09/17
JPMS
11/09/17
UPGRADE
Target $162
JPMS
Overweight
Alnylam upgraded to Overweight from Neutral at JPMorgan
JPMorgan analyst Anupam Rama upgraded Alnylam Pharmaceuticals saying he believes patisiran "has definitively solidified" a dominant market position in the ATTR amyloidosis space. The analyst expects a "smooth regulatory process" for patisiran and broad label enabling use in the mutant mixed FAC phenotype. Rama raised his price target for Alnylam shares to $162 from $86.
11/08/17
LEHM
11/08/17
NO CHANGE
Target $158
LEHM
Overweight
Alnylam price target raised to $158 from $127 at Barclays
Barclays analyst Gena Wang raised her price target for Alnylam Pharmaceuticals to $158 saying the company highlighted multiple pipeline progresses during the Q3 earnings call. The analyst keeps an Overweight rating on the shares.
11/03/17
COWN
11/03/17
NO CHANGE
Target $151
COWN
Outperform
Alnylam price target raised to $151 from $117 at Cowen
Cowen analyst Ritu Baral raised her price target on Alnylam to $151 from $117 following its presentation of full data from the Phase 3 APOLLO trial of patisiran. The data showed benefits in cardiac measure and excellent safety and approval should be expected in 2018 with a broad label. Baral reiterated her Outperform rating on Alnylam shares.
SNY Sanofi
$43.70

0.46 (1.06%)

12/06/17
BOFA
12/06/17
DOWNGRADE
BOFA
Neutral
Sanofi downgraded to Neutral from Buy at BofA/Merrill
BofA/Merrill analyst Graham Perry downgraded Sanofi to Neutral citing valuation and lack of earnings momentum into 2018.
12/01/17
MSCO
12/01/17
DOWNGRADE
MSCO
Underweight
Sanofi downgraded to Underweight from Overweight at Morgan Stanley
11/16/17
EVER
11/16/17
NO CHANGE
Target $445
EVER
Outperform
Regeneron price target lowered to $445 from $605 at Evercore ISI
Evercore ISI lowered its price target for Regeneron (REGN) to $445 from $605 given meaningful competitive threat to Eylea. For every dollar of U.S. Eylea sales lost to competition, Regeneron has to make up for it with two times as much revenue from the Sanofi (SNY) JV, it adds. The firm has an Outperform rating on Regeneron's shares.
11/15/17
LEHM
11/15/17
UPGRADE
LEHM
Equal Weight
Sanofi upgraded to Equal Weight from Underweight at Barclays
Barclays upgraded Sanofi to Equal Weight from Underweight saying valuation is back to more reasonable levels.

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MA

MasterCard

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AUTL

Autolus Therapeutics

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Arrow Electronics

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Pfizer

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AMBA

Ambarella

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BF.B

Brown-Forman, also tag with BFA, BFB

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Brown-Forman, also tag with BF.A, BF.B

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07:13
Upgrade
Brown-Forman, also tag with BFA, BFB, Brown-Forman, also tag with BF.A, BF.B, Brown-Forman, also tag with BF.A, BF.B rating change  »

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FB

Facebook

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Periodicals
Facebook uses 'shielded review' process for popular pages, The Guardian reports »

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CHUY

Chuy's

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DLR

Digital Realty

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NFLX

Netflix

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Bloomin' Brands

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CANF

Can-Fite BioPharma

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Can-Fite BioPharma receives patent from China, Australia for sexual dysfunction »

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CoreSite Realty

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INNT

Innovate Biopharmaceuticals

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AST

Asterias

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Asterias provides six month data readout for AST-OPC1 Phase 1/2a clinical trial »

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NSU

Nevsun Resources

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CONE

CyrusOne

$61.71

0.08 (0.13%)

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KKR

KKR

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VYGR

Voyager Therapeutics

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PacWest Bancorp

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IBM

IBM

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EVGN

Evogene

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RTN

Raytheon

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