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REGN

Regeneron

$351.27

-29.44 (-7.73%)

07:19
10/25/18
10/25
07:19
10/25/18
07:19

Regeneron says FDA issues CRL for EYLEA pre-filled syringe

Regeneron announced that the U.S. Food and Drug Administration issued a complete response letter, or CRL, regarding the Chemistry, Manufacturing and Controls Prior-Approval Supplement for the EYLEA pre-filled syringe. The CRL requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the EYLEA pre-filled syringe in approximately 30 patients. Regeneron expects to compile all the requested information and resubmit the PAS in early 2019 and continues to expect a 2019 launch of the EYLEA pre-filled syringe.

  • 28

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REGN Regeneron
$351.27

-29.44 (-7.73%)

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.
10/22/18
PIPR
10/22/18
NO CHANGE
Target $450
PIPR
Overweight
Regeneron asthma label for Dupixent broad as hoped, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond says that while Regeneron Pharmaceuticals' asthma label for Dupixent does not broadly cover patients regardless of eosinophilic phenotype as he had anticipated, it does cover oral corticosteroid dependent patients regardless of eosinophilic phenotype, which essentially matches his modeling. Moreover, the analyst notes that the label covers all patients 12 and older, and both moderate and severe disease. As such, he sees the label as broad, "but not necessarily as anticipated." The analyst is making no change to his numbers based on the label and keeps an Overweight rating on Regeneron with a $450 price target.
10/22/18
CANT
10/22/18
NO CHANGE
Target $441
CANT
Neutral
Regeneron price target raised to $441 from $419 at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young raised her price target for Regeneron Pharmaceuticals to $441 citing Dupixent's label in asthma, which she thinks is broad. The analyst believes the shares could trade up 5% on the label but she keeps a Neutral rating on the name. Dupixent expectations are high already, Young tells investors in a research note.

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AAPL

Apple

$179.03

-0.64 (-0.36%)

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SPCB

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USEG

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MYOV

Myovant Sciences

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MYOV

Myovant Sciences

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Novartis

$87.49

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, QGEN

Qiagen

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$87.49

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QGEN

Qiagen

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AVH

Avianca

$3.96

0.91 (29.84%)

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AAPL

Apple

$179.03

-0.64 (-0.36%)

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SHSP

SharpSpring

$16.37

-0.24 (-1.44%)

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CREG

China Recycling Energy

$0.48

0.005 (1.05%)

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FENC

Fennec

$3.88

(0.00%)

16:36
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TD

Toronto-Dominion

$56.66

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CBUS

Cibus

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BA

Boeing

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FB

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HPQ

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DVAX

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VIX

Volatility Index S&P 500 Options

$0.00

(0.00%)

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$NSD

NASDAQ Market Internals

$0.00

(0.00%)

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$NYE

NYSE Market Internals

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(0.00%)

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NYSE market internals summary »

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RHE

Regional Health Properties

$2.06

0.09 (4.57%)

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TBIO

Translate Bio

$9.12

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