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TRVN

Trevena

$1.01

0.0339 (3.49%)

07:24
11/04/19
11/04
07:24
11/04/19
07:24

Trevena expects to resubmit NDA for oliceridine in 1Q20

The company said, "Completed multi-dose QT study for oliceridine. No accumulation of effect was observed on the QT interval. A small, transient effect, consistent with that observed in the single-dose QT study, began dissipating after 12 hours and was absent at the end of the 24-hour study period despite repeated dosing of oliceridine. Oliceridine was well tolerated, with 59 subjects receiving the 27 mg maximum daily dose. There were no serious adverse events. In addition to this data, the Company previously announced that it has completed the work to address the other items requested by FDA in their complete response letter for oliceridine. The Company expects to resubmit the NDA for oliceridine in the first quarter of 2020."

  • 04

    Nov

TRVN Trevena
$1.01

0.0339 (3.49%)

11/05/18
HCWC
11/05/18
DOWNGRADE
Target $0.75
HCWC
Neutral
Trevena downgraded to Neutral from Buy at H.C. Wainwright
H.C. Wainwright analyst Ed Arce downgraded Trevena to Neutral and lowered his price target for the shares to 75c from $3.00. Following the Complete Response Letter from the FDA on the new drug application for oliceridin, a second-pass PDUFA date is unlikely until early 2020, Arce tells investors in a research note. He believes the CRL "leaves several open questions."
05/31/19
HCWC
05/31/19
INITIATION
Target $3.5
HCWC
Buy
Trevena assumed with a Buy at H.C. Wainwright
H.C. Wainwright analyst Douglas Tsao assumed coverage of Trevena with a Buy rating and $3.50 price target. The analsut believes the questions raised in the Complete Response Letter appear manageable and that Olinvo has a "clear path to approval." He expects Trevena shares to move higher as the company addresses the items needed to bring Olinvo to market.
09/03/19
HCWC
09/03/19
NO CHANGE
HCWC
Trevena's oliceridine 'close to the finish line,' says H.C. Wainwright
H.C. Wainwright analyst Douglas Tsao maiontained a Buy rating and $3.50 price target on Trevena. The analyst noted that Trevena recently announced that it completed enrollment for its ongoing healthy volunteer QT study and remained on track to support topline data readout in Q4. Trevena also said that more than 20 of 30 subjects at that point had received the maximum daily dose of 27mg of oliceridine, a key FDA requirement for the trial. This gives Tsao "confidence that the trial should be successful."

TODAY'S FREE FLY STORIES

SAGE

Sage Therapeutics

$60.11

-89.11 (-59.72%)

16:53
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Sage Therapeutics analyst commentary  »

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EMN

Eastman Chemical

$75.68

0.67 (0.89%)

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Eastman Chemical raises quarterly dividend 6.5% to 66c from 62c per share »

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EVRI

Everi Holdings

$11.86

-1 (-7.78%)

16:43
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Everi Holdings 10M share Secondary priced at $11.25 »

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    Dec

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ZUMZ

Zumiez

$30.63

0.67 (2.24%)

16:39
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Zumiez raises FY19 SSS growth view to 4.0%-4.5% from prior view 2.0%-4.0% »

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CRWD

Crowdstrike

$53.00

-2.04 (-3.71%)

16:38
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Earnings
Crowdstrike raises FY20 EPS view to (53c)-(52c) from (65c)-(62c) »

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FNHC

Federated National

$15.37

-0.04 (-0.26%)

16:36
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Federated National announces new $10M share repurchase program »

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CRWD

Crowdstrike

$53.00

-2.04 (-3.71%)

16:36
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Earnings
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    Dec

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    Dec

CRWD

Crowdstrike

$53.00

-2.04 (-3.71%)

16:35
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Earnings
Crowdstrike reports Q3 adjusted EPS (7c), consensus (11c) »

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  • 05

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EPZM

Epizyme

$15.32

-0.48 (-3.04%)

16:35
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16:35
Upgrade
Epizyme rating change  »

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ESTA

Establishment Labs

$24.31

0.32 (1.33%)

16:35
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IDT

IDT Corp

$7.47

0.26 (3.61%)

16:34
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Earnings
IDT Corp reports Q1 EPS 10c vs. (2c) last year »

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  • 05

    Dec

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    Dec

KODK

Kodak

$2.59

0.085 (3.39%)

16:33
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Kodak's Karfunkel acquires over 4.4M common shares »

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PAC

GAP Airports

$99.66

-1.12 (-1.11%)

16:32
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GAP Airports reports November traffic up 10.1% »

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JOE

Saint Joe Co.

$19.49

0.7 (3.73%)

16:32
12/05/19
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St. Joe, HomeCorp to build additional 120 apartment homes in Panama City Beach »

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ALEC

Alector

$19.44

-0.17 (-0.87%)

16:32
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Alector announces FDA fast track designation granted to AL001 for dementia »

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MGLN

Magellan Health

$76.79

-0.12 (-0.16%)

16:31
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Magellan Health names James Murray as President and COO »

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SWIR

Sierra Wireless

$9.15

0.12 (1.33%)

16:31
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Sierra Wireless CFO Dave McLennan retiring in mid-2020 »

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  • 13

    Feb

ASR

Asur

$167.79

-1.88 (-1.11%)

16:30
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Asur reports total November passenger traffic up 7.3% »

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AXNX

Axonics

$25.05

0.92 (3.81%)

16:30
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Integrated Core Strategies reports 5.1% passive stake in Axonics »

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COO

Cooper Companies

$313.10

1 (0.32%)

16:30
12/05/19
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Earnings
Cooper Companies sees Q1 EPS $2.65-$2.75, consensus $2.97 »

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  • 05

    Dec

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    Dec

  • 13

    Dec

16:30
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Options
Preliminary option volume of 14.7M today »

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COO

Cooper Companies

$312.96

0.86 (0.28%)

16:28
12/05/19
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16:28
Earnings
Cooper Companies sees FY20 EPS $12.60-$13.30, consensus $13.10 »

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    Dec

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    Dec

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    Dec

BOLD

Audentes Therapeutics

$59.19

-0.09 (-0.15%)

, ALPMY

Astellas Pharma

$0.00

(0.00%)

16:27
12/05/19
12/05
16:27
12/05/19
16:27
Downgrade
Audentes Therapeutics, Astellas Pharma rating change  »

Audentes Therapeutics…

BOLD

Audentes Therapeutics

$59.19

-0.09 (-0.15%)

ALPMY

Astellas Pharma

$0.00

(0.00%)

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  • 07

    Dec

ZUMZ

Zumiez

$30.63

0.67 (2.24%)

16:27
12/05/19
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16:27
Earnings
Zumiez provides Q4 quarter to date sales update »

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  • 05

    Dec

  • 05

    Dec

ZUMZ

Zumiez

$30.63

0.67 (2.24%)

16:26
12/05/19
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16:26
Earnings
Zumiez sees FY19 EPS $2.38- $2.46, consensus $2.16 »

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  • 05

    Dec

  • 05

    Dec

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