Breaking News Instant updates and real-time market news.

ZGNX

Zogenix

$47.58

-0.15 (-0.31%)

16:10
12/02/19
12/02
16:10
12/02/19
16:10

Zogenix announces Phase 3 Fintepla data published

Zogenix announced that JAMA Neurology has published the results of Zogenix's Phase 3 study of the investigational drug, Fintepla, in Dravet syndrome patients whose antiepileptic drug treatment regimens included stiripentol but who were still experiencing a high number of convulsive seizures. Dravet syndrome is a rare, severe and difficult to treat infantile-onset epilepsy characterized by frequent, disabling seizures. The study demonstrated that adding Fintepla to these patients' treatment regimens led to a significant and clinically meaningful reduction in monthly convulsive seizure frequency, or MCSF. Study 1504 was an international, double-blind, placebo-controlled Phase 3 study of 87 Dravet syndrome patients age 2-19 taking background anti-epileptic drug regimens that included stiripentol, randomized to placebo or Fintepla 0.4 mg/kg/day. The study was conducted at 28 centers in Canada, France, Germany, the Netherlands, Spain, the United Kingdom and the United States. Eligible patients in the trial were experiencing seizures that were poorly controlled with their current anti-seizure medications consisting of stiripentol plus clobazam and/or valproic acid. After a 6-week period to establish baseline seizure frequency, patients were randomized to receive Fintepla starting at a dose of 0.2 mg/kg/day, twice-daily with gradual blinded titration over a three week period to 0.4 mg/kg/d over three weeks. Patients maintained their regimen for an additional 12 weeks at a stable dose, then either continued treatment in an open-label extension study or discontinued treatment. The study met its primary efficacy endpoint and all key secondary endpoints. Patients treated with Fintepla achieved a 54% greater reduction in mean MCSF than those receiving the placebo. Additionally, 54% of patients treated with Fintepla experienced a clinically meaningful reduction in MCSF versus 5% with placebo. Profound seizure reduction was experienced by 35% of Fintepla-treated patients compared to 2% with placebo. The median longest seizure-free interval was 22 days with Fintepla and 13 days with placebo. In the study, Fintepla was generally well-tolerated and demonstrated a safety profile consistent with the findings of Zogenix's first Phase 3 study of Fintepla in Dravet syndrome, called Study 1, as well as with findings from an analysis of the company's ongoing open-label extension study. The most common adverse events in Study 1504 were decreased appetite, fatigue and pyrexia. Across all three studies, no patient exhibited clinical or echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension.

  • 03

    Dec

  • 25

    Mar

ZGNX Zogenix
$47.58

-0.15 (-0.31%)

06/27/19
06/27/19
UPGRADE
Target $64

Buy
Zogenix upgraded to Buy Fintepla NDA news at Guggenheim
As previously reported, Guggenheim analyst Yatin Suneja upgraded Zogenix to Buy from Neutral after speaking with management following the news on Fintepla NDA resubmission in Dravet in Q3. The analyst believes the company has a clear understanding with the FDA on potential approval pathway and views the news as the best case scenario. The company also announced the loss of breakthrough designation, which is surprising but in line with FDA policy, he notes, adding however, that it does not change his view on the approvability of the drug and thinks priority review could help with a speedy approval. Suneja also raised his price target on the shares to $64 from $40.
06/28/19
MZHO
06/28/19
NO CHANGE
Target $65
MZHO
Buy
Zogenix price target raised to $65 from $58 at Mizuho
Mizuho analyst Difei Yang raised her price target for Zogenix to $65 from $58 following the FDA's decision to allow a re-submission of the new drug application for Fintepla. The analyst believes a priority review is highly likely and views the FDA's decision as a positive. She reiterates a Buy rating on Zogenix shares.
08/26/19
PIPR
08/26/19
NO CHANGE
PIPR
Overweight
Zogenix should be bought on weakness from Modis deal, says Piper Jaffray
Piper Jaffray analyst Danielle Brill recommends buying shares of Zogenix on weakness following the company's acquisition of Modis Therapeutics. While pipeline diversification makes sense, investors are likely thrown off by the timing of the deal, given the proximity to Fintepla approval, Brill tells investors in a research note. Also, a potential near-term takeover of Zogenix now seems unlikely, adds the analyst. However, she still thinks Fintepla will be a commercial success. Brill expects Zogenix shares to recover after the new drug application filing is accepted and she keeps an Overweight rating on the name with a $64 price target. The stock in afternoon trading is down 13%, or $6.68, to $43.33.
10/21/19
NEED
10/21/19
INITIATION
Target $58
NEED
Buy
Zogenix initiated with a Buy at Needham
Needham analyst Serge Belanger initiated coverage of Zogenix with a Buy rating and $58 price target, citing its Fintepla drug returning to the path of a potential regulatory approval by the FDA. The analyst contends that the drug will play a "niche but consequential role" in treating rare pediatric epilepsy disorders given the high levels of efficacy and seizure freedom in treating Dravet Syndrome, or DS, patients. Belanger believes that Fintepla will be approved by the FDA in the first half of next year thanks to its efficacy and manageable safety profile, as well as a "significant unmet need in DS."

TODAY'S FREE FLY STORIES

WFT

Weatherford

$0.00

(0.00%)

18:49
12/13/19
12/13
18:49
12/13/19
18:49
Hot Stocks
Weatherford completes financial restructuring, emerges from Chapter 11 »

Weatherford announced…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CNC

Centene

$57.71

-0.81 (-1.38%)

18:40
12/13/19
12/13
18:40
12/13/19
18:40
Hot Stocks
Centene CEO: Our big markets are growing, we're gaining share »

In an interview on…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 13

    Dec

LYV

Live Nation

$64.24

-5.205 (-7.50%)

, ZBRA

Zebra Technologies

$257.82

-0.32 (-0.12%)

18:29
12/13/19
12/13
18:29
12/13/19
18:29
Hot Stocks
S&P announces changes to S&P 400, 500, 600 indices »

S&P Dow Jones Indices…

LYV

Live Nation

$64.24

-5.205 (-7.50%)

ZBRA

Zebra Technologies

$257.82

-0.32 (-0.12%)

STE

Steris

$151.93

-1.745 (-1.14%)

AMG

Affiliated Managers

$85.18

-1.77 (-2.04%)

TRIP

TripAdvisor

$29.24

-0.2 (-0.68%)

MAC

Macerich

$26.04

-0.46 (-1.74%)

LOPE

Grand Canyon

$89.24

-0.86 (-0.95%)

LEA

Lear

$129.43

-0.84 (-0.64%)

OAS

Oasis Petroleum

$2.68

-0.295 (-9.93%)

SWN

Southwestern Energy

$2.00

-0.12 (-5.66%)

UNT

Unit Corp.

$0.83

-0.0626 (-6.98%)

FTR

Frontier Communications

$0.68

0.0315 (4.84%)

ARWR

Arrowhead

$66.47

-0.91 (-1.35%)

GVA

Granite Construction

$26.21

-1.335 (-4.85%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 26

    Feb

  • 23

    Mar

PLAN

Anaplan

$51.80

1.44 (2.86%)

18:23
12/13/19
12/13
18:23
12/13/19
18:23
Hot Stocks
Anaplan CEO: Digitization has really started to accelerate »

In an interview on…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

WPX

WPX Energy

$10.92

-0.24 (-2.15%)

18:08
12/13/19
12/13
18:08
12/13/19
18:08
Periodicals
WPX Energy in talks to acquire Felix Energy assets for $2.5B, Bloomberg says »

WPX Energy is in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 23

    Mar

HLIT

Harmonic

$7.94

-0.25 (-3.05%)

17:47
12/13/19
12/13
17:47
12/13/19
17:47
Hot Stocks
Harmonic CFO sells 28K shares of common stock »

In a regulatory filing,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

HZNP

Horizon Pharma

$32.84

(0.00%)

17:36
12/13/19
12/13
17:36
12/13/19
17:36
Hot Stocks
Breaking Hot Stocks news story on Horizon Pharma »

Horizon Pharma up 9.6% to…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 13

    Dec

  • 08

    Mar

AMRN

Amarin

$24.12

1.12 (4.87%)

17:33
12/13/19
12/13
17:33
12/13/19
17:33
Hot Stocks
Breaking Hot Stocks news story on Amarin »

Amarin rises 1.4% to…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

THMO

ThermoGenesis

$2.88

(0.00%)

17:31
12/13/19
12/13
17:31
12/13/19
17:31
Syndicate
Breaking Syndicate news story on ThermoGenesis »

ThermoGenesis files $30M…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AMRN

Amarin

$24.12

1.12 (4.87%)

17:30
12/13/19
12/13
17:30
12/13/19
17:30
Hot Stocks
Breaking Hot Stocks news story on Amarin 

Amarin trading resumes

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

QTNT

Quotient

$8.60

-0.165 (-1.88%)

17:28
12/13/19
12/13
17:28
12/13/19
17:28
Syndicate
Breaking Syndicate news story on Quotient »

Quotient files to sell…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

ARWR

Arrowhead

$66.47

-0.91 (-1.35%)

, GVA

Granite Construction

$26.21

-1.335 (-4.85%)

17:27
12/13/19
12/13
17:27
12/13/19
17:27
Hot Stocks
Breaking Hot Stocks news story on Arrowhead, Granite Construction »

Arrowhead to replace…

ARWR

Arrowhead

$66.47

-0.91 (-1.35%)

GVA

Granite Construction

$26.21

-1.335 (-4.85%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

OAS

Oasis Petroleum

$2.68

-0.295 (-9.93%)

, SWN

Southwestern Energy

$2.00

-0.12 (-5.66%)

17:25
12/13/19
12/13
17:25
12/13/19
17:25
Hot Stocks
Oasis, Southwestern to replace Unit Corp., Frontier in S&P 600 at open on 12/23 »

Oasis Petroleum (OAS) and…

OAS

Oasis Petroleum

$2.68

-0.295 (-9.93%)

SWN

Southwestern Energy

$2.00

-0.12 (-5.66%)

UNT

Unit Corp.

$0.83

-0.0626 (-6.98%)

FTR

Frontier Communications

$0.68

0.0315 (4.84%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 23

    Mar

AMRN

Amarin

$24.12

1.12 (4.87%)

17:24
12/13/19
12/13
17:24
12/13/19
17:24
Hot Stocks
Amarin raises guidance after FDA approves Vascepa »

Amarin (AMRN) shares…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

LOPE

Grand Canyon

$89.24

-0.86 (-0.95%)

, LEA

Lear

$129.43

-0.84 (-0.64%)

17:22
12/13/19
12/13
17:22
12/13/19
17:22
Hot Stocks
Grand Canyon, Lear to replace Oasis, Southwestern in S&P 400 at open on 12/23 »

Grand Canyon Education…

LOPE

Grand Canyon

$89.24

-0.86 (-0.95%)

LEA

Lear

$129.43

-0.84 (-0.64%)

OAS

Oasis Petroleum

$2.68

-0.295 (-9.93%)

SWN

Southwestern Energy

$2.00

-0.12 (-5.66%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 23

    Mar

RTN

Raytheon

$217.31

-0.93 (-0.43%)

17:20
12/13/19
12/13
17:20
12/13/19
17:20
Hot Stocks
Raytheon awarded $123.53M Navy contract modification »

Raytheon was awarded a…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

LYV

Live Nation

$64.24

-5.205 (-7.50%)

, ZBRA

Zebra Technologies

$257.82

-0.32 (-0.12%)

17:19
12/13/19
12/13
17:19
12/13/19
17:19
Hot Stocks
Live Nation, Zebra Technologies, Steris to move to S&P 500 at open on 12/23 »

Live Nation (LYV), Zebra…

LYV

Live Nation

$64.24

-5.205 (-7.50%)

ZBRA

Zebra Technologies

$257.82

-0.32 (-0.12%)

STE

Steris

$151.93

-1.745 (-1.14%)

AMG

Affiliated Managers

$85.18

-1.77 (-2.04%)

TRIP

TripAdvisor

$29.24

-0.2 (-0.68%)

MAC

Macerich

$26.04

-0.46 (-1.74%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 26

    Feb

BAESY

BAE Systems

$0.00

(0.00%)

17:15
12/13/19
12/13
17:15
12/13/19
17:15
Hot Stocks
BAE Systems awarded $249.15M Army contract modification »

BAE Systems was awarded a…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

WST

West Pharmaceutical

$146.32

-0.14 (-0.10%)

17:02
12/13/19
12/13
17:02
12/13/19
17:02
Hot Stocks
West Pharmaceutical announces 848K share repurchase authorization »

On December 10, 2019, the…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AMRN

Amarin

$24.12

1.12 (4.87%)

17:02
12/13/19
12/13
17:02
12/13/19
17:02
Earnings
Amarin sees FY20 revenue $650M-$700M, consensus $654.55M »

With respect to 2020,…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

IBIO

iBio

$0.22

-0.0179 (-7.43%)

17:01
12/13/19
12/13
17:01
12/13/19
17:01
Hot Stocks
iBio receives NYSE noncompliance notice »

iBio, Inc. announced that…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

APLT

Applied Therapeutics

$21.23

0.29 (1.38%)

16:59
12/13/19
12/13
16:59
12/13/19
16:59
Syndicate
Breaking Syndicate news story on Applied Therapeutics »

Applied Therapeutics…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AMRN

Amarin

$24.12

1.12 (4.87%)

16:59
12/13/19
12/13
16:59
12/13/19
16:59
Earnings
Amarin raises FY19 revenue view to $410M-$425M from $380M-$420M 

FY19 consensus $410.25M.

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

BIO

Bio-Rad

$354.69

-8.005 (-2.21%)

16:56
12/13/19
12/13
16:56
12/13/19
16:56
Hot Stocks
Bio-Rad progressing from ransomware attack recovery detected on Dec 5th »

Bio-Rad Laboratories…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AMRN

Amarin

$24.12

1.12 (4.87%)

16:50
12/13/19
12/13
16:50
12/13/19
16:50
Hot Stocks
Amarin confirms FDA approval of Vascepa »

Amarin announced that the…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 28

    Dec

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.