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NVAX

Novavax

$4.69

0.12 (2.63%)

07:16
10/15/19
10/15
07:16
10/15/19
07:16

Novavax initiates Phase 3 clinical trial for NanoFlu

Novavax announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over. The trial, for which the first participants have been enrolled, will evaluate the immunogenicity and safety of NanoFlu with its proprietary Matrix-M adjuvant, compared to a U.S.-licensed quadrivalent influenza vaccine. Top-line clinical data from the randomized, observer-blinded, active-controlled trial is expected in the first quarter of 2020 and would support a subsequent U.S. biologics license application and licensure of NanoFlu using the U.S. Food and Drug Administration's accelerated approval pathway. This pathway enables Novavax to conduct this non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure. The trial will enroll approximately 2,650 healthy older adults across 19 U.S. clinical sites. Trial participants will receive either NanoFlu or the comparator, both of which will be formulated with the four influenza strains recommended for the 2019-2020 Northern hemisphere influenza season. Participants will be followed for approximately one year after injection, with primary immunogenicity analyses of the Day 28 sera samples. The trial's primary objective is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition titers of vaccine homologous influenza strains compared to a licensed seasonal vaccine, and to describe its safety profile.

NVAX Novavax
$4.69

0.12 (2.63%)

07/01/19
HCWC
07/01/19
NO CHANGE
Target $12
HCWC
Buy
Novavax price target raised to $12 from $10 at H.C. Wainwright
H.C. Wainwright analyst Vernon Bernardino raised his price target for Novavax to $12 from $10 saying the company's arrangement where Paragon Gene Therapy is a positive for its operational goals. The arrangement significantly reduces Novavax's operating costs, which involves an immediate 50% reduction beginning in July when the transaction is expected to close, Bernardino tells investors in a research note. He reiterates a Buy rating on the shares.
08/14/19
HCWC
08/14/19
NO CHANGE
Target $17
HCWC
Buy
Novavax price target raised to $17 from $10 at H.C. Wainwright
H.C. Wainwright analyst Vernon Bernardino raised his price target for Novavax to $17 from $10 and reiterates a Buy rating on the shares. The stock closed yesterday up 28c to $4.30. The agreement on a Phase 3 trial design for NanoFlu that Novavax announced with the FDA on August 5 sets the stage for the program to accelerate, Bernardino tells investors in a research note. The analyst believes Novavax's NanoFlu vaccine can now be approved in 2022 versus his prior expectation of 2024. He looks for share price appreciation to allow "successful financings" in 2020 and 2021, positioning Novavax to independently launch commercial NanoFlu worldwide.
09/10/19
OPCO
09/10/19
NO CHANGE
Target $13
OPCO
Outperform
Novavax price target lowered to $13 from $25 at Oppenheimer
Oppenheimer analyst Kevin DeGeeter lowered his price target for Novavax to $13 from $25 after the company filed an 8-K disclosing EMA declined to support use of the conditional marketing authorization pathway for approval of ResVax in the EU. While the decision does not formally prevent Novavax from filing with EMA, the analyst believes that approval without an additional clinical trial is now unlikely. DeGeeter reiterates an Outperform rating based on continued optimism for a positive Phase III result for NanoFlu in Q1 2020. Furthermore, given increased clarity on the regulatory path for ResVax, he believes there is stronger logic for management to seek a sale of the company following NanoFlu data
09/24/19
SBSH
09/24/19
NO CHANGE
Target $15
SBSH
Buy
Citi drops Novavax target to $15 on 'unusually high cash challenges'
Citi analyst Joel Beatty continues to view the combined value of Novavax's respiratory syncytial virus and flu vaccines are higher than the company's current enterprise value of ~$400M. However, he lowered his price target for the shares to $15 from $19 to reflect the "unusually high cash challenges for the company." Beatty expects positive NanoFlu results in Q1 of 2020, but says any upside to the stock from these results is unlikely to be sustained unless Novavax is also able to obtain meaningful non-dilutive funding related to one or both of its lead vaccine candidates. The analyst keeps a Buy rating on the shares, adding that the company's two late-stage vaccines may attract interest from large pharma.

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PAYC

Paycom

$239.80

4.63 (1.97%)

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06:39
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QCOM

Qualcomm

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-2.52 (-2.79%)

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TGT

Target

$110.86

0.27 (0.24%)

06:38
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06:38
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AVY

Avery Dennison

$131.42

0.26 (0.20%)

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TGT

Target

$110.86

0.27 (0.24%)

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ADSK

Autodesk

$164.53

2.08 (1.28%)

06:37
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QIWI

Qiwi

$20.14

0.38 (1.92%)

06:36
11/20/19
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06:36
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06:36
Earnings
Qiwi raises FY19 adjusted revenue growth view to 15%-19% from 9%-15% »

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TGT

Target

$110.86

0.27 (0.24%)

06:35
11/20/19
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06:35
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06:35
Earnings
Target sees Q4 adj. EPS $1.54-$1.75, consensus $1.65 

Sees Q4 SSS up 3%-4%.

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TJX

TJX

$60.66

1.12 (1.88%)

06:34
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T

AT&T

$38.00

-1.61 (-4.06%)

06:34
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LLY

Eli Lilly

$115.13

1.04 (0.91%)

06:34
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Eli Lilly to invest $400M in Indianapolis manufacturing facilities »

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TGT

Target

$110.86

0.27 (0.24%)

06:33
11/20/19
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Earnings
Target reports Q3 adj. EPS $1.36, consensus $1.19 »

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CDXC

ChromaDex

$3.49

0.19 (5.76%)

06:33
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QIWI

Qiwi

$20.14

0.38 (1.92%)

06:33
11/20/19
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06:33
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06:33
Earnings
Qiwi reports Q3 EPS 29c, one estimate 33c »

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  • 20

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EVRG

Evergy

$64.79

-0.19 (-0.29%)

06:29
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06:29
Downgrade
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RES

RPC, Inc.

$3.84

-0.015 (-0.39%)

06:26
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Downgrade
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QD

Qudian

$5.63

-0.295 (-4.98%)

06:24
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WE

We Company

$0.00

(0.00%)

, SFTBF

SoftBank

$0.00

(0.00%)

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$0.00

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SoftBank

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SoftBank

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BRY

Berry Petroleum

$8.90

-2.405 (-21.27%)

06:21
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BBCP

Concrete Pumping

$3.88

0.17 (4.58%)

06:21
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Conference/Events
Concrete Pumping management to meet with William Blair »

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  • 20

    Nov

EVRG

Evergy

$64.79

-0.19 (-0.29%)

06:20
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06:20
Downgrade
Evergy rating change  »

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M

Macy's

$15.03

-1.85 (-10.96%)

06:20
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Periodicals
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  • 21

    Nov

AL

Air Lease

$45.16

0.435 (0.97%)

06:20
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  • 20

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BRY

Berry Petroleum

$8.90

-2.405 (-21.27%)

06:19
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XGN

Exagen

$19.25

-0.04 (-0.21%)

06:19
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Conference/Events
Exagen management to meet with William Blair »

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