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REGN

Regeneron

$389.94

-5.45 (-1.38%)

, SNY

Sanofi

$44.57

0.12 (0.27%)

17:57
10/19/18
10/19
17:57
10/19/18
17:57

Regeneron, Sanofi: FDA approves asthma indication for Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced the U.S. FDA has approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent inhibits the overactive signaling of interleukin-4 and interleukin-13, two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide, immunoglobulin E and eotaxin-3.

REGN

Regeneron

$389.94

-5.45 (-1.38%)

SNY

Sanofi

$44.57

0.12 (0.27%)

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    May

REGN Regeneron
$389.94

-5.45 (-1.38%)

10/01/18
LEER
10/01/18
NO CHANGE
Target $512
LEER
Outperform
Regeneron price target raised to $512 from $506 at Leerink
Leerink analyst Geoffrey Porges raised his price target for Regeneron to $512 from $506 after the FDA approved the jointly developed and commercialized REGN/SNY PD-1 antibody cemiplimab, now known as Libtayo. The analyst reiterates an Outperform rating on the shares.
10/11/18
PIPR
10/11/18
NO CHANGE
Target $450
PIPR
Overweight
Piper remains buyer of Regeneron ahead of October 20 FDA action date
Piper Jaffray analyst Christopher Raymond says he remains a buyer of Regeneron Pharmaceuticals (REGN) ahead of the Dupixent asthma October 20 FDA action date. With consensus expecting this indication to contribute well over $1B in revenue in coming years, approval is a "critical near-term catalyst" for the shares, Raymond tells investors in a research note. The analyst adds that while some investors have expressed angst over the breadth of the label, namely restricting use to eosinophilic asthma, he believes recent Sanofi (SNY) commentary provides reason for optimism. The totality of clinical data and the biology behind Dupixent supports a broad label, Raymond contends. He maintains an Overweight rating on Regeneron with a $450 price target.
10/16/18
LEER
10/16/18
NO CHANGE
LEER
Outperform
Regeneron data won't derail Intersect ENT's Sinuva, says Leerink
Leerink analyst Richard Newitter attributes the underperformance today in shares of Intersect ENT (XENT) to Regeneron's (REGN) positive Phase 3 Dupixent data for chronic rhinosinusitis with nasal polyps. The Dupixent readout had always represented a potential headline risk for Intersect ENT during Q4, Newitter tells investors in a research note. The analyst, however, thinks it's better to get the headline out of the way before a J-code decision in early November. Further, based on physician feedback around monoclonal antibodies, Newitter does not get the sense that these therapies will "necessarily derail" adoption of Intersect ENT's Sinuva or its total addressable market. The analyst continues to believe in-line Q3 results will be a "win" for Intersect ENT and he keeps an Outperform rating on the shares. The stock in afternoon trading is down 68c to $29.24.
10/17/18
JEFF
10/17/18
NO CHANGE
Target $31
JEFF
Buy
Jefferies still sees 'major' opportunity for Optinose after Dupixent data
Optinose (OPTN) shares underperformed yesterday following the positive Phase 3 results for Sanofi (SNY) and Regeneron's (REGN) Dupixent in treating patients with chronic rhinosinusitis with nasal polyps, Jefferies analyst David Steinberg tells investors in a research note titled "Biologics Competitor as Expected; Real World Pricing Issues Likely to Limit Us." The analyst says that while Dupixent demonstrated strong efficacy, clinicians he's spoken with believe that the "massive" pricing disparity versus nasal steroids will likely result in payer "step edits" that could limit widespread adoption of the "expensive" biologics currently under development. Further, Dupixent's head-to-head comparison with Optinose's Xhance's "strong" efficacy profile is difficult, the analyst adds. Steinberg still sees a "major" long-term opportunity for Xhance and keeps a Buy rating on Optinose with a $31 price target.
SNY Sanofi
$44.57

0.12 (0.27%)

10/09/18
BARD
10/09/18
INITIATION
Target $50
BARD
Outperform
Principia Biopharma initiated with an Outperform at Baird
Baird analyst Brian Skorney started Principia Biopharma (PRNB) with an Outperform rating and $50 price target, stating that its BTK inhibitor partnered with Sanofi (SNY) for multiple sclerosis has blockbuster potential. He also believes PRN1008, which is entering Phase 3, has a worldwide opportunity over $500M in pemphigus that would also open the door for a host of other indications.
10/16/18
WELS
10/16/18
NO CHANGE
WELS
Drug price in ads not impactful, may cause confusion, says Wells Fargo
Wells Fargo analyst David Maris acknowledges that the U.S. Department of Health and Human Services' proposal to include drug prices in advertisements has a "noble goal" of making drugs more affordable and keeping patients well informed. However, given how different list prices are relative to out of pocket costs, "one must ask if this is increasing transparency or likely going to lead to more confusion," he contends. The analyst also believes that the unintended consequence could be worse care, while noting that the drug price information will likely fall into the category of the side effect information in drug ads currently, tuned out by many and will have no material impact. While he supports the idea of increased transparency, Maris wonders whether the potential benefit is not outweighed by the potential negative for the most vulnerable. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

TODAY'S FREE FLY STORIES

21:25
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General news
Fed's Rosengren warned that U.S. Q1 growth is likely to be weak »

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BBBY

Bed Bath & Beyond

$13.87

0.17 (1.24%)

20:44
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Activist firms seek to replace Bed Bath & Beyond board, CEO, WSJ says »

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RTN

Raytheon

$180.58

-0.82 (-0.45%)

, BA

Boeing

$370.52

8.37 (2.31%)

20:36
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Raytheon kill vehicle hits ICBM target in first dual-salvo test »

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RTN

Raytheon

$180.58

-0.82 (-0.45%)

BA

Boeing

$370.52

8.37 (2.31%)

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General news
The "Summary of Opinions" from the BoJ's March meeting »

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WHD

Cactus

$36.03

1.225 (3.52%)

20:27
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Cactus VP of Operations sells 229K shares of common stock »

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CCL

Carnival

$56.67

-0.065 (-0.11%)

, MKC

McCormick

$143.88

1.58 (1.11%)

20:25
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Earnings
Notable companies reporting before tomorrow's open »

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CCL

Carnival

$56.67

-0.065 (-0.11%)

MKC

McCormick

$143.88

1.58 (1.11%)

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CRTO

Criteo

$21.99

-3.4 (-13.39%)

20:19
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20:19
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20:19
Downgrade
Criteo rating change at KeyBanc »

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SSNLF

Samsung

$0.00

(0.00%)

20:02
03/25/19
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20:02
Periodicals
Samsung sees weaker environment for display, memory in Q1, Bloomberg says »

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BA

Boeing

$370.52

8.37 (2.31%)

19:51
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Hot Stocks
U.S. MDA and Boeing Complete Historic Missile Defense Test »

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  • 28

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MCD

McDonald's

$185.66

-1.11 (-0.59%)

19:49
03/25/19
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19:49
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19:49
Periodicals
McDonald's purchase price of Dynamic Yield above $300M, Bloomberg says »

The purchase of Dynamic…

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  • 30

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SSNLF

Samsung

$0.00

(0.00%)

19:32
03/25/19
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19:32
03/25/19
19:32
Periodicals
Breaking Periodicals news story on Samsung »

Samsung sees Q1 below…

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AWR

American States Water

$71.51

0.505 (0.71%)

19:22
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19:22
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19:22
Hot Stocks
American States Water CEO sells 12.4K shares of common stock »

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MEOH

Methanex

$56.35

-1.38 (-2.39%)

19:10
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19:10
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19:10
Hot Stocks
Methanex confirms receipt of director nominees notice from M&G »

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BECN

Beacon Roofing

$34.14

0.81 (2.43%)

, SAEX

SAExploration

$4.03

0.13 (3.33%)

18:55
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Hot Stocks
Fly Intel: After Hours Movers »

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BECN

Beacon Roofing

$34.14

0.81 (2.43%)

SAEX

SAExploration

$4.03

0.13 (3.33%)

IQ

iQIYI

$24.01

-0.86 (-3.46%)

MYOK

MyoKardia

$51.87

-2.44 (-4.49%)

CTMX

CytomX Therapeutics

$10.76

0.33 (3.16%)

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HPQ

HP Inc.

$18.97

-0.4 (-2.07%)

18:48
03/25/19
03/25
18:48
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18:48
Periodicals
HP lawyer tells court Autonomy's Lynch inflated sales data, Reuters says »

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  • 23

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PEGA

Pegasystems

$63.61

-0.27 (-0.42%)

18:45
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Hot Stocks
Pegasystems CEO: We are massively changing our marketing strategy »

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  • 22

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SMTC

Semtech

$52.59

-0.38 (-0.72%)

18:32
03/25/19
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Hot Stocks
Semtech CEO sells 25K shares of common stock »

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  • 25

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TMO

Thermo Fisher

$268.89

5.015 (1.90%)

18:24
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Thermo Fisher CEO: We have a very disciplined M&A process »

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DJX

Dow Jones Industrial Average

$0.00

(0.00%)

, SPX

S&P 500

$0.00

(0.00%)

18:24
03/25/19
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18:24
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18:24
Periodicals
Parliament forces votes on Brexit plan options, Bloomberg reports »

Lawmakers of U.K.…

DJX

Dow Jones Industrial Average

$0.00

(0.00%)

SPX

S&P 500

$0.00

(0.00%)

SPY

SPDR S&P 500 ETF Trust

$278.99

-0.56 (-0.20%)

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MCD

McDonald's

$185.66

-1.11 (-0.59%)

18:23
03/25/19
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Hot Stocks
McDonald's to acquire Dynamic Yield, terms not stated »

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BA

Boeing

$370.52

8.37 (2.31%)

18:22
03/25/19
03/25
18:22
03/25/19
18:22
Periodicals
Boeing software fix to prevent repeated activiation of MCAS, Reuters says »

A Boeing software repair…

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  • 28

    May

ACHC

Acadia

$29.47

-0.59 (-1.96%)

17:58
03/25/19
03/25
17:58
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Hot Stocks
Acadia says President Brett Turner leaving by mutual agreement »

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AAPL

Apple

$188.78

-2.33 (-1.22%)

17:41
03/25/19
03/25
17:41
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17:41
Recommendations
Apple analyst commentary at Piper Jaffray »

Apple price target raised…

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  • 25

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ZFGN

Zafgen

$2.70

-0.15 (-5.26%)

17:38
03/25/19
03/25
17:38
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17:38
Hot Stocks
Armistice Capital reports 5.6% passive stake in Zafgen »

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NOC

Northrop Grumman

$268.56

0.27 (0.10%)

17:36
03/25/19
03/25
17:36
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17:36
Hot Stocks
Northrop Grumman awarded $245.05M Navy contract modification »

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