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ALNY

Alnylam

$82.00

2.51 (3.16%)

07:04
10/15/18
10/15
07:04
10/15/18
07:04

Alnylam announces plan to initiate rolling submission of NDA for givosiran

Alnylam Pharmaceuticals announced that in consultation with the U.S. Food and Drug Administration, the Company plans to pursue a full approval based on the complete results of the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria, rather than filing based on the interim Phase 3 results. The FDA has also agreed to a rolling submission of a New Drug Application, which will be initiated in 2018 with full clinical sections submitted in mid-2019, assuming positive study results. Alnylam previously reported positive topline results from the interim analysis of the ENVISION Phase 3 study of givosiran demonstrating a statistically significant reduction in urinary ALA levels, a surrogate biomarker that is reasonably likely to predict clinical benefit. As previously reported, serious adverse events were reported in 22 percent of givosiran patients and 10 percent of placebo patients in the interim analysis cohort of 43 patients, with one patient on givosiran discontinuing treatment due to an increase in liver transaminase that resolved. Alnylam continues to dose patients in the ongoing ENVISION study, where enrollment was completed ahead of schedule with 94 AHP patients. The Company expects to report topline full study results of the primary endpoint - the annualized attack rate after six months of treatment - in early 2019. As previously guided, the Company intends to file for marketing authorization in all other markets based on the complete results of the ENVISION Phase 3 study, assuming positive results.

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ALNY Alnylam
$82.00

2.51 (3.16%)

10/15/18
PIPR
10/15/18
NO CHANGE
PIPR
Piper lists names to own in Biopharma after recent selloff
Piper Jaffray's biopharma analyst team highlighted names to own in the Biopharma sector following the recent selloff of the broader market. The firm's ideas include: Adamas Pharmaceuticals (ADMS), Agios Pharmaceuticals (AGIO), Agios Pharmaceuticals (ALNY), Alexion (ALXN), Bluebird Bio (BLUE), BioMarin (BMRN), CymaBay (CBAY), Crispr Therapeutics (CRSP), Global Blood Therapeutics (GBT), Horizon Pharma (HZNP), Jazz Pharmaceuticals (JAZZ), Ocular Therapeutix (OCUL), Rigel Pharmaceuticals (RIGL) and Xencor (XNCR).
10/08/18
GSCO
10/08/18
NO CHANGE
Target $36
GSCO
Sell
Ionis' Tegsedi to face commercial headwinds, says Goldman Sachs
After the FDA approved Ionis (IONS) and affiliate Akcea Therapeutics' (AKCA) Tegsedi for adult polyneuropathy of hereditary transthyretin-mediated amyloidosis, but with a black box warning, Goldman Sachs analyst Salveen Richter said he believes the drug faces commercial headwinds. He cites the underlying safety profile and requirement for consistent monitoring as well as the recent launch of Alnylam's (ALNY) Onpattro and expected launch of Pfizer's (PFE) tafamidis in the first half of 2019. Richter keeps a Sell rating on Ionis shares with a price target of $36.
10/08/18
CANT
10/08/18
INITIATION
Target $135
CANT
Overweight
Cantor reiterates Overweight on Alnylam after Akcea, Ionis win approval
Cantor Fitzgerald analyst Alethia Young reiterates an Overweight rating on Alnylam Pharmaceuticals (ALNY) with a $135 price target after the FDA approved Tegsedi, to be marketed by Akcea Therapeutics (AKCA). The analyst says that while the approval introduces another competitor to the market, she still expects Alnylam's Onpattroto be able to take significant share in the polyneuropathy hATTR market. Young thinks the Tegsedi label is more onerous and currently models a 60% peak share to Alnylam, a 25% share to Tegsedi and 15% to future competition.
10/07/18
PIPR
10/07/18
NO CHANGE
Target $160
PIPR
Overweight
Alnylam's Onpattro highly efficacious, safer than competitor, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff notes that Ionis Pharmaceuticals (IONS) announced FDA approval of TEGSEDI for treatment of hATTR polyneuropathy. The analyst also points out that the label includes a Black Box warning for thrombocytopenia and glomerulonephritis requiring every 2-week monitoring, and will be marketed by Ionis subsidiary Akcea (AKCA) with a Risk Evaluation and Mitigation Strategy. TEGSEDI is administered subcutaneously every week versus Alnylam's (ANLY) ONPATTRO intravenously every 3 weeks with steroids, he adds. Tenthoff believes that ONPATTRO appears safer and highly efficacious, and should win out. The analyst reiterates an Overweight rating and $160 price target on Alnylam shares.

TODAY'S FREE FLY STORIES

GM

General Motors

$36.62

0.3 (0.83%)

21:16
10/23/19
10/23
21:16
10/23/19
21:16
Periodicals
Flint, Michigan UAW approves labor deal with General Motors, Bloomberg reports »

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GLD

SPDR Gold Shares

$140.57

0.4 (0.29%)

20:29
10/23/19
10/23
20:29
10/23/19
20:29
Hot Stocks
SPDR Gold Shares holdings fall to 918.48MT from 919.66MT »

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CMCSA

Comcast

$45.74

-0.04 (-0.09%)

, CMCSK

Comcast

$0.00

(0.00%)

20:25
10/23/19
10/23
20:25
10/23/19
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

CMCSA

Comcast

$45.74

-0.04 (-0.09%)

CMCSK

Comcast

$0.00

(0.00%)

DHR

Danaher

$138.39

1.19 (0.87%)

MMM

3M

$168.62

1.06 (0.63%)

NOC

Northrop Grumman

$352.89

0.48 (0.14%)

RTN

Raytheon

$203.81

-1.08 (-0.53%)

BAX

Baxter

$87.90

0.87 (1.00%)

DOW

Dow Inc.

$47.29

0.47 (1.00%)

HSY

Hershey

$149.67

-0.06 (-0.04%)

TWTR

Twitter

$38.83

0.01 (0.03%)

LUV

Southwest

$53.27

0.375 (0.71%)

TROW

T. Rowe Price

$108.01

0.01 (0.01%)

SWK

Stanley Black & Decker

$153.73

2.42 (1.60%)

HBAN

Huntington Bancshares

$14.49

0.06 (0.42%)

CTXS

Citrix

$103.60

-0.5 (-0.48%)

TSCO

Tractor Supply

$95.02

0.8 (0.85%)

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AMZN

Amazon.com

$1,761.81

-4.26 (-0.24%)

20:22
10/23/19
10/23
20:22
10/23/19
20:22
Hot Stocks
Ceiva Logic sues Amazon for patent infringement »

CEIVA Logic announced it…

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DLGNF

Dialog Semiconductor

$0.00

(0.00%)

20:17
10/23/19
10/23
20:17
10/23/19
20:17
Earnings
Dialog Semiconductor sees Q3 revenue $409M, up from prior $360M-$400M view »

As a result of the higher…

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HBMD

Howard Bancorp

$16.20

-0.23 (-1.40%)

19:17
10/23/19
10/23
19:17
10/23/19
19:17
Earnings
Howard Bancorp reports Q3 EPS 24c, two estimates 25c »

Reports Q3 NII $17.2M,…

03/08/13
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TSLA

Tesla

$254.93

-0.69 (-0.27%)

19:02
10/23/19
10/23
19:02
10/23/19
19:02
Hot Stocks
Tesla CFO says Model Y margins will be slightly higher than Model 3 »

Says Model Y cost…

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    Oct

PUB

People's Utah Bancorp

$28.93

-0.57 (-1.93%)

18:58
10/23/19
10/23
18:58
10/23/19
18:58
Earnings
People's Utah Bancorp reports Q3 EPS 59c, consensus 59c »

"People's Utah…

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    Oct

TSLA

Tesla

$254.93

-0.69 (-0.27%)

, MKSI

MKS Instruments

$94.65

-1.26 (-1.31%)

18:57
10/23/19
10/23
18:57
10/23/19
18:57
Hot Stocks
Fly Intel: After Hours Movers »

UP AFTER EARNINGS: Tesla…

TSLA

Tesla

$254.93

-0.69 (-0.27%)

MKSI

MKS Instruments

$94.65

-1.26 (-1.31%)

ALGN

Align Technology

$217.25

3.62 (1.69%)

FFIV

F5 Networks

$138.33

-0.71 (-0.51%)

MX

MagnaChip

$11.97

-0.2 (-1.64%)

PYPL

PayPal

$96.55

-0.85 (-0.87%)

LRCX

Lam Research

$233.22

-1.69 (-0.72%)

VAR

Varian Medical

$117.42

2.83 (2.47%)

NOW

ServiceNow

$220.01

-8.25 (-3.61%)

SAVE

Spirit Airlines

$37.73

0.48 (1.29%)

SEIC

SEI Investments

$57.20

-0.21 (-0.37%)

EW

Edwards Lifesciences

$224.58

2.66 (1.20%)

PTC

PTC

$66.91

1.07 (1.63%)

ORLY

O'Reilly Automotive

$400.49

-0.08 (-0.02%)

BMRN

BioMarin

$69.07

1.34 (1.98%)

CMRE

Costamare

$7.31

0.25 (3.54%)

SLM

Sallie Mae

$9.06

0.005 (0.06%)

CLB

Core Laboratories

$43.80

1.525 (3.61%)

AEM

Agnico Eagle

$54.09

1.03 (1.94%)

MSFT

Microsoft

$137.23

0.84 (0.62%)

NTGR

Netgear

$30.63

-1.32 (-4.13%)

FTI

TechnipFMC

$23.40

-0.1 (-0.43%)

EBAY

eBay

$39.22

0.25 (0.64%)

KRA

Kraton

$21.47

-0.51 (-2.32%)

F

Ford

$9.20

0.14 (1.55%)

MMLP

Martin Midstream Partners

$4.42

-0.03 (-0.67%)

XLNX

Xilinx

$93.83

-2.18 (-2.27%)

DHT

DHT Holdings

$7.68

0.3 (4.07%)

EFX

Equifax

$139.06

-0.2 (-0.14%)

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TSLA

Tesla

$254.93

-0.69 (-0.27%)

18:45
10/23/19
10/23
18:45
10/23/19
18:45
Hot Stocks
Tesla CFO says global order rate is 'strong and continues to increase' »

Says lower CapEx in Q3…

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  • 23

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NOW

ServiceNow

$220.01

-8.25 (-3.61%)

, NKE

Nike

$92.30

-3.31 (-3.46%)

18:44
10/23/19
10/23
18:44
10/23/19
18:44
Hot Stocks
ServiceNow CEO: I have a twenty year relationship with Nike »

In an interview on…

NOW

ServiceNow

$220.01

-8.25 (-3.61%)

NKE

Nike

$92.30

-3.31 (-3.46%)

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TSLA

Tesla

$254.93

-0.69 (-0.27%)

18:40
10/23/19
10/23
18:40
10/23/19
18:40
Hot Stocks
Tesla CEO says self-driving 'appears to be on track' for release by year-end »

Says releasing version 3…

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  • 23

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PKG

Packaging Corp.

$110.11

1.48 (1.36%)

18:40
10/23/19
10/23
18:40
10/23/19
18:40
Earnings
Packaging Corp. reports Q3 EPS ex-items $1.92, consensus $1.90 »

Reports Q3 revenue $1.8B,…

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TSLA

Tesla

$254.93

-0.69 (-0.27%)

18:38
10/23/19
10/23
18:38
10/23/19
18:38
Hot Stocks
Tesla CEO says made great strides in controlling costs during Q3 »

Operating cost is lowest…

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  • 23

    Oct

POOL

Pool Corp.

$206.03

-6.87 (-3.23%)

18:32
10/23/19
10/23
18:32
10/23/19
18:32
Hot Stocks
Pool Corp. CFO sells 5,000 common shares »

In a regulatory filing,…

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    Nov

GOOG

Alphabet

$1,259.62

16.835 (1.35%)

, GOOGL

Alphabet Class A

$1,257.88

16.8 (1.35%)

18:29
10/23/19
10/23
18:29
10/23/19
18:29
Periodicals
Google accused of building spy software curb worker dissent, Bloomberg says »

Google workers are…

GOOG

Alphabet

$1,259.62

16.835 (1.35%)

GOOGL

Alphabet Class A

$1,257.88

16.8 (1.35%)

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NFBK

Northfield Bancorp

$16.88

0.04 (0.24%)

18:18
10/23/19
10/23
18:18
10/23/19
18:18
Earnings
Northfield Bancorp reports Q3 EPS 28c, consensus 26c »

Reports Q3 revenue…

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  • 13

    Nov

BRP

BRP Group

$0.00

(0.00%)

18:16
10/23/19
10/23
18:16
10/23/19
18:16
Syndicate
BRP Group 16.4M share IPO priced at $14.00 »

The deal priced at low…

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  • 24

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GOOG

Alphabet

$1,259.62

16.835 (1.35%)

, GOOGL

Alphabet Class A

$1,257.88

16.8 (1.35%)

18:04
10/23/19
10/23
18:04
10/23/19
18:04
Periodicals
Google accused of building spy software curb worker dissent, Bloomberg says »

Google workers are…

GOOG

Alphabet

$1,259.62

16.835 (1.35%)

GOOGL

Alphabet Class A

$1,257.88

16.8 (1.35%)

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MSFT

Microsoft

$137.23

0.84 (0.62%)

18:03
10/23/19
10/23
18:03
10/23/19
18:03
Hot Stocks
Microsoft sees Q2 Productivity and Business Processes revenue $11.3B-$11.5B »

Sees Q2: Intelligent…

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TSLA

Tesla

$254.93

-0.69 (-0.27%)

18:02
10/23/19
10/23
18:02
10/23/19
18:02
Hot Stocks
Breaking Hot Stocks news story on Tesla »

Tesla up 20.6% after…

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  • 23

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ISTR

Investar Holding

$24.00

0.01 (0.04%)

18:01
10/23/19
10/23
18:01
10/23/19
18:01
Earnings
Investar Holding reports Q3 EPS 46c, consensus 48c »

Reports Q3 revenue…

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  • 13

    Nov

MSFT

Microsoft

$137.23

0.84 (0.62%)

17:58
10/23/19
10/23
17:58
10/23/19
17:58
Hot Stocks
Microsoft says 'off to strong start' to FY20 »

Says: Investing…

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FIBK

First Interstate

$43.01

0.34 (0.80%)

17:53
10/23/19
10/23
17:53
10/23/19
17:53
Earnings
First Interstate reports Q3 EPS 76c, consensus 79c »

Reports Q3 revenue…

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MYGN

Myriad Genetics

$31.58

-0.71 (-2.20%)

, GSK

GlaxoSmithKline

$43.25

0.74 (1.74%)

17:43
10/23/19
10/23
17:43
10/23/19
17:43
Hot Stocks
Myriad Genetics announces FDA approval of myChoice CDx test »

Myriad Genetics (MYGN)…

MYGN

Myriad Genetics

$31.58

-0.71 (-2.20%)

GSK

GlaxoSmithKline

$43.25

0.74 (1.74%)

03/08/13
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