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SNI

Scripps Networks

$0.00

(0.00%)

, LXRX

Lexicon

$7.51

-0.45 (-5.65%)

14:16
03/22/19
03/22
14:16
03/22/19
14:16

Sanofi says FDA issues CRL for Zynquista

The U.S. Food and Drug Administration issued a Complete Response Letter regarding the New Drug Application for investigational Zynquista, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin. A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form. Sanofi (SNY) and Lexicon (LXRX) will work closely with the FDA to determine the appropriate next steps.

SNI

Scripps Networks

$0.00

(0.00%)

LXRX

Lexicon

$7.51

-0.45 (-5.65%)

  • 22

    Mar

  • 25

    Apr

SNI Scripps Networks
$0.00

(0.00%)

LXRX Lexicon
$7.51

-0.45 (-5.65%)

01/22/19
WEDB
01/22/19
NO CHANGE
Target $36
WEDB
Outperform
Lexicon price target lowered to $36 from $42 at Wedbush
Wedbush analyst Liana Moussatos lowered her price target for Lexicon to $36 from $42, while reiterating an Outperform rating on the shares as she sees the split AdComm selloff "overdone." On January 17, the Endocrinologic and Metabolic Drug Advisory Committee had a split vote for/against approval of sotagliflozin as potentially the first oral antidiabetic drug used as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes, she notes. The analyst points out that this was the first AdComm for an oral medication for T1D and the non-diabetes experts may have been thinking about T2D A1c drops not on insulin when criticizing the clinical meaningfulness of the 0.2%-0.4% placebo adjusted A1c drop for sotagliflozin. Moussatos also believes the DKA safety issue was "blown out of proportion." Even if FDA issues a CRL on March 22nd to allow more time to develop a RMS or even REMS, the analyst anticipates approval.
03/13/19
GABE
03/13/19
DOWNGRADE
GABE
Sell
Lexicon downgraded to Sell from Hold at Gabelli
03/14/19
GABE
03/14/19
DOWNGRADE
GABE
Sell
Lexicon downgraded to Sell at Gabelli on expected FDA rejection of sotagliflozin
As previously reported, Gabelli analyst Kevin Kedra downgraded Lexicon to Sell from Hold, citing his expectation that the FDA will reject sotagliflozin in type 1 diabetes by its March 22 PDUFA date following a split AdCom vote in January. He believes the FDA is likely to require additional information regarding a risk mitigation strategy to reduce incidences of diabetic ketoacidosis in type 1 patients on sotagliflozin, which is "a manageable hurdle," but one that will likely take additional time to navigate, Kedra tells investors. He has reduced his 2020 private market value estimate for Lexicon shares to $6.00 from $6.50.
03/14/19
03/14/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Lexicon (LXRX) downgraded to Sell from Hold at Gabelli with analyst Kevin Kedra citing his expectation that the FDA will reject sotagliflozin in type 1 diabetes by its March 22 PDUFA date following a split AdCom vote in January. 2. Sun Life Financial (SLF) downgraded to Underperformer from Neutral at CIBC. 3. Yum China (YUMC) downgraded to Outperform from Buy at Daiwa with analyst Adrian Chan citing valuation but says long-term growth remains intact. 4. Line Corp. (LN) downgraded to Underperform from Neutral at Credit Suisse. 5. Nabors Industries (NBR) downgraded to Neutral from Buy at Citi with analyst Scott Gruber saying Nabors' free cash flow outlook is weighted towards the second half of 2019, with Q1 likely to be a cash burn of $40M-plus. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

UPS

UPS

$120.71

1.61 (1.35%)

21:22
09/20/19
09/20
21:22
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21:22
Conference/Events
UPS management to meet with UBS »

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    Sep

DIS

Disney

$132.18

-1.14 (-0.86%)

, T

AT&T

$37.92

0.78 (2.10%)

18:17
09/20/19
09/20
18:17
09/20/19
18:17
Periodicals
Disney reaches TV carriage agreement with AT&T, Bloomberg says »

The deal includes ESPN on…

DIS

Disney

$132.18

-1.14 (-0.86%)

T

AT&T

$37.92

0.78 (2.10%)

03/08/13
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  • 23

    Oct

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BA

Boeing

$379.33

-5.28 (-1.37%)

18:15
09/20/19
09/20
18:15
09/20/19
18:15
Periodicals
Icelandair reaches deal for Boeing to cover costs associated with 737, WSJ says »

Icelandair Group said it…

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  • 02

    Oct

MCF

Contango Oil & Gas

$1.71

-0.07 (-3.93%)

17:58
09/20/19
09/20
17:58
09/20/19
17:58
Hot Stocks
Karlin Asset Management reports 11.4% passive stake in Contango Oil & Gas »

Karlin Asset Management…

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GLD

SPDR Gold Shares

$142.97

1.68 (1.19%)

17:41
09/20/19
09/20
17:41
09/20/19
17:41
Hot Stocks
SPDR Gold Shares holdings rise to 894.15MT from 883.60MT »

This is the highest level…

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VXRT

Vaxart

$0.58

-0.0307 (-5.03%)

17:37
09/20/19
09/20
17:37
09/20/19
17:37
Syndicate
Vaxart files to sell 15.6M shares of common stock »

H.C. Wainwright acted as…

03/08/13
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AAPL

Apple

$217.69

-3.22 (-1.46%)

17:34
09/20/19
09/20
17:34
09/20/19
17:34
Periodicals
Apple given tariff exclusion on certain Mac Pro parts, Bloomberg says »

Apple has received U.S.…

03/08/13
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03/06/13
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IIVI

II-VI

$39.05

-0.5 (-1.26%)

, CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

17:31
09/20/19
09/20
17:31
09/20/19
17:31
Hot Stocks
II-VI to enter S&P 400; Callon Petroleum, PriceSmart to enter S&P SmallCap600 »

S&P SmallCap 600…

IIVI

II-VI

$39.05

-0.5 (-1.26%)

CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

FNSR

Finisar

$24.31

1.25 (5.42%)

03/08/13
Wedge Partners
03/08/13
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03/06/13
Citigroup
03/06/13
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  • 23

    Sep

  • 24

    Sep

  • 02

    Oct

  • 30

    Oct

NVR

NVR

$3,632.55

-30.45 (-0.83%)

, JEF

Jefferies Financial Group

$19.47

-0.19 (-0.97%)

17:26
09/20/19
09/20
17:26
09/20/19
17:26
Hot Stocks
NVR to replace Jefferies Financial Group in the S&P 500 at open on September 26 »

NVR (NVR) will replace…

NVR

NVR

$3,632.55

-30.45 (-0.83%)

JEF

Jefferies Financial Group

$19.47

-0.19 (-0.97%)

SPB

Spectrum Brands

$49.66

-1.395 (-2.73%)

03/08/13
Wedge Partners
03/08/13
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03/06/13
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03/06/13
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  • 16

    Oct

NOC

Northrop Grumman

$368.25

-7.45 (-1.98%)

17:24
09/20/19
09/20
17:24
09/20/19
17:24
Hot Stocks
Northrop Grumman subsidiary awarded $1.12B Missile Defense Agency contract »

Orbital Sciences, or OSC,…

03/08/13
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PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

, FNSR

Finisar

$24.31

1.25 (5.42%)

17:23
09/20/19
09/20
17:23
09/20/19
17:23
Hot Stocks
Breaking Hot Stocks news story on PriceSmart, Finisar »

PriceSmart to replace…

PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

FNSR

Finisar

$24.31

1.25 (5.42%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
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03/06/13
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  • 30

    Oct

IIVI

II-VI

$39.05

-0.5 (-1.26%)

, CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

17:22
09/20/19
09/20
17:22
09/20/19
17:22
Hot Stocks
Breaking Hot Stocks news story on II-VI, Callon Petroleum »

II-VI to replace Callon…

IIVI

II-VI

$39.05

-0.5 (-1.26%)

CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
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03/06/13
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  • 23

    Sep

  • 24

    Sep

  • 02

    Oct

NVR

NVR

$3,632.55

-30.45 (-0.83%)

17:20
09/20/19
09/20
17:20
09/20/19
17:20
Hot Stocks
Breaking Hot Stocks news story on NVR »

NVR to replace Jefferies…

03/08/13
Wedge Partners
03/08/13
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03/06/13
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03/06/13
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NHYDY

Norsk Hydro

$0.00

(0.00%)

17:12
09/20/19
09/20
17:12
09/20/19
17:12
Hot Stocks
Norsk Hydro discloses federal court in Brazil lifts embargo on Alunortes »

The Federal Court in…

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RESN

Resonant

$3.05

0.02 (0.66%)

17:03
09/20/19
09/20
17:03
09/20/19
17:03
Conference/Events
Resonant participates in a conference call with Loop Capital »

Semiconductor Analysts…

03/08/13
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  • 01

    Oct

  • 12

    Nov

NINE

Nine Energy Services

$6.73

-0.33 (-4.67%)

17:02
09/20/19
09/20
17:02
09/20/19
17:02
Syndicate
Breaking Syndicate news story on Nine Energy Services »

Nine Energy Services…

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ATOM

Atomera

$3.70

0.17 (4.82%)

17:00
09/20/19
09/20
17:00
09/20/19
17:00
Conference/Events
Atomera participates in a conference call with Loop Capital »

Semiconductor Analysts…

03/08/13
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MPWR

Monolithic Power

$154.21

-2 (-1.28%)

16:50
09/20/19
09/20
16:50
09/20/19
16:50
Conference/Events
Monolithic Power participates in a conference call with Loop Capital »

Semiconductor Analysts…

03/08/13
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  • 02

    Oct

  • 03

    Oct

  • 04

    Oct

AAPL

Apple

$217.69

-3.22 (-1.46%)

16:45
09/20/19
09/20
16:45
09/20/19
16:45
Periodicals
Breaking Periodicals news story on Apple »

Apple given tariff…

03/08/13
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IDA

IDACORP

$111.26

0.93 (0.84%)

16:36
09/20/19
09/20
16:36
09/20/19
16:36
Hot Stocks
IDACORP raises quarterly dividend to 67c from 63c per share »

The company states:…

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  • 10

    Nov

MO

Altria Group

$40.80

0.69 (1.72%)

16:33
09/20/19
09/20
16:33
09/20/19
16:33
Hot Stocks
Altria Group recommends rejection of amended mini-tender by TRC »

Altria Group states it…

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EADSY

Airbus

$0.00

(0.00%)

, AL

Air Lease

$42.68

-0.615 (-1.42%)

16:32
09/20/19
09/20
16:32
09/20/19
16:32
Hot Stocks
Air Lease announces delivery of new A321-200neo to Air Astana »

Air Lease Corporation…

EADSY

Airbus

$0.00

(0.00%)

AL

Air Lease

$42.68

-0.615 (-1.42%)

03/08/13
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  • 13

    Nov

16:30
09/20/19
09/20
16:30
09/20/19
16:30
Options
Preliminary option volume of 23.5M today »

Preliminary option volume…

PSX

Phillips 66

$103.26

0.14 (0.14%)

16:28
09/20/19
09/20
16:28
09/20/19
16:28
Periodicals
Phillips 66 says Beaumont oil terminal ops still shut down, Reuters says »

Phillips 66 said that…

03/08/13
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03/06/13
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  • 25

    Oct

POST

Post Holdings

$105.73

0.335 (0.32%)

16:24
09/20/19
09/20
16:24
09/20/19
16:24
Hot Stocks
Post files IPO for active nutrition unit BellRing Brands »

Post Holdings, Inc.…

03/08/13
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03/06/13
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