Breaking News Instant updates and real-time market news.

ARDM

Aradigm

$5.24

0.04 (0.77%)

07:22
12/01/16
12/01
07:22
12/01/16
07:22

Aradigm says Pulmaquin 'safe,' 'well tolerated' in ORBIT-3, ORBIT-4 trials

Aradigm announced top-line results from its two Phase 3 clinical trials evaluating the safety and efficacy of Pulmaquin, the company's investigational proprietary formulation of once daily ciprofloxacin for inhalation, in patients with non-cystic fibrosis bronchiectasis with chronic lung infections with Pseudomonas aeruginosa. The ORBIT-3 and ORBIT-4 pivotal trials were identical in design except for a pharmacokinetics sub-study that was conducted in one of the trials. The primary endpoint in both ORBIT-3 and ORBIT-4 was an increase in the median time to first mild, moderate or severe pulmonary exacerbation. The key secondary efficacy endpoint in both trials was the frequency of PE's over the 48-week double-blind treatment period. In ORBIT-4 the median time to first mild, moderate or severe PE was 230 days in the Pulmaquin treatment group as compared to 163 days in the placebo group. This increase in the median time to first PE was statistically significant using non-stratified log-rank analysis. In the key secondary efficacy endpoint, there was a 37% reduction in the frequency of PE's over the 48-week treatment period in the Pulmaquin treatment group as compared to the placebo group. This result was statistically significant with a Hazard Ratio of Pulmaquin/placebo of 0.63 using non-stratified binomial regression. In ORBIT-3 the median time to first mild, moderate or severe PE was 221 days in the Pulmaquin treatment group as compared to 136 days in the placebo group. This increase in the median time to first PE was similar to ORBIT-4 but was not statistically significant using non-stratified log-rank analysis. In the key secondary efficacy endpoint, there was a 13% reduction in the frequency of PE's over the 48-week treatment period in the Pulmaquin treatment group as compared to the placebo group. This result was not statistically significant with a Hazard Ratio of Pulmaquin/placebo of 0.87 using non-stratified binomial regression. The analyses of combined data from both studies resulted in a statistically significant reduction in the number of PE's over the 48-week double-blind period, representing a 27% reduction in PE's over the period. When the additional analyses of combined data from both studies were conducted taking into account only PE's that were moderate or severe the median time to first PE in the Pulmaquin group was 302 days vs. placebo 198 days. There was also a statistically significant reduction in the number of moderate and severe PE's over the 48-week double-blind period using non-stratified analysis, representing a 33% reduction in PE's over the period. In each study, the treatment groups were stratified for gender, pre-trial frequency of exacerbations and smoking status. The Statistical Analysis Plan for the studies called for stratified analyses; however, since some strata were found to have no or very few subjects, both non-stratified and stratified analyses were conducted. The company believes that due to the limited number of subjects in some strata the non-stratified analyses are more appropriate as strata that are too small can produce highly unstable estimated treatment effects with potential outliers. Using the stratified analyses, the median time to first PE in ORBIT-3 was Pulmaquin: 221 days; placebo: 136 days; p=0.7681 and for ORBIT-4 was Pulmaquin: 230 days; placebo: 163 days; p=0.0885. Both studies demonstrated a statistically significant reduction in P. aeruginosa density at Day 28, the end of the first on-treatment period. For each study, the magnitude of this antibiotic effect remained persistent throughout all on-treatment periods. Pulmaquin was safe and well tolerated in both studies. There were no differences in the changes of lung function or symptoms of airway irritation between the Pulmaquin and placebo groups in the two studies. Overall, the incidence of all treatment emergent adverse events was similar between the Pulmaquin and placebo groups in both ORBIT-3 and ORBIT-4. In ORBIT-3 the rates of serious TEAEs were 30.6% with Pulmaquin and 25.3% with placebo while in ORBIT-4 the rates were 17.0% versus 28.6%. For each study, the randomization rate of Pulmaquin treated subjects to placebo was 2 to 1. There were 8 deaths in ORBIT-3 and 6 deaths in ORBIT-4; placebo: 4. None of the deaths was related to Pulmaquin or placebo. The most frequently observed treatment related TEAEs were of respiratory/thoracic/mediastinal nature and were reported in ORBIT-3 by 25.7% of subjects with Pulmaquin and in 21.1% of subjects with placebo, while the rates in ORBIT-4 were 16.5% with Pulmaquin versus 19.4% with placebo. After the completion of the 48-week double-blind period, both Pulmaquin and placebo treated patients were given the opportunity to receive Pulmaquin in a 28-day open label extension period. 89% of the patients who completed ORBIT-3 and 91% of the patients who completed ORBIT-4 enrolled in the extension period. The company also announced that it has received the final statistical analysis report from the two year inhalation carcinogenicity study in rats with Pulmaquin; there were no differences in the rate of observed tumors between the Pulmaquin and control groups. Aradigm has been granted orphan drug designation for Pulmaquin for non-CF BE in the U.S. In addition, FDA has designated Pulmaquin as a Qualified Infectious Disease Product. The QIDP designation is granted for treatment of non-CF BE patients with chronic lung infections with P. aeruginosa and made Pulmaquin eligible for Fast Track designation which was granted by the FDA in September 2014. Further data from the Phase 3 studies will be presented in future publications and medical meetings.

TODAY'S FREE FLY STORIES

02:50
04/27/17
04/27
02:50
04/27/17
02:50
General news
FX Update: USD-JPY has traded higher »

FX Update: USD-JPY has…

FND

Floor & Decor Holdings

20:03
04/26/17
04/26
20:03
04/26/17
20:03
Syndicate
Floor & Decor Holdings 8.824M share IPO priced at $21.00 »

The deal priced above 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

  • 26

    Apr

  • 27

    Apr

SNE

Sony

$33.58

-0.07 (-0.21%)

, FOX

21st Century Fox

$30.05

0.16 (0.54%)

20:02
04/26/17
04/26
20:02
04/26/17
20:02
Periodicals
Sony narrows search for studio boss to Vinciquerra, WSJ says »

Former Fox (FOX) TV head…

SNE

Sony

$33.58

-0.07 (-0.21%)

FOX

21st Century Fox

$30.05

0.16 (0.54%)

FOXA

21st Century Fox

$30.74

0.13 (0.42%)

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

  • 08

    May

  • 10

    May

  • 24

    May

  • 25

    May

  • 15

    Jun

VZ

Verizon

$47.36

0.66 (1.41%)

19:57
04/26/17
04/26
19:57
04/26/17
19:57
Periodicals
Verizon go90 boss departs, Business Insider says »

Verizon go90 chief Chip…

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

  • 09

    May

SSNLF

Samsung

19:45
04/26/17
04/26
19:45
04/26/17
19:45
Hot Stocks
Samsung sees FY17 earnings growth, cites health in memory, OLED »

"Moving on to 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

SSNLF

Samsung

19:42
04/26/17
04/26
19:42
04/26/17
19:42
Hot Stocks
Samsung sees Q2 growth due to 'robust' memory performance, Galaxy S8 launch »

"Looking ahead 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

SSNLF

Samsung

19:40
04/26/17
04/26
19:40
04/26/17
19:40
Earnings
Samsung reports Q1 operating profit 9.9T won vs. 6.68T won last year »

Reports Q1 revenue 50.55T…

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

ADM

Archer Daniels

$45.27

-0.31 (-0.68%)

19:36
04/26/17
04/26
19:36
04/26/17
19:36
Periodicals
Archer Daniels appoints new head of global trading desk, Reuters says »

Archer Daniels has…

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

  • 02

    May

FTI

TechnipFMC

$32.26

0.14 (0.44%)

19:35
04/26/17
04/26
19:35
04/26/17
19:35
Earnings
TechnipFMC reports Q1 adjusted EPS 71c, consensus 33c »

Reports Q1 revenue…

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

  • 27

    Apr

  • 01

    May

F

Ford

$11.60

0.12 (1.05%)

, GM

General Motors

$34.38

0.39 (1.15%)

19:29
04/26/17
04/26
19:29
04/26/17
19:29
Periodicals
Transportation, EPA chiefs to meet with major automakers, Reuters says »

Transportation Secretary…

F

Ford

$11.60

0.12 (1.05%)

GM

General Motors

$34.38

0.39 (1.15%)

TM

Toyota

$109.91

1.19 (1.09%)

VLKAY

Volkswagen

$32.13

-0.2 (-0.62%)

FCAU

Fiat Chrysler

$11.65

1.11 (10.53%)

DDAIF

Daimler AG

$74.57

-0.6001 (-0.80%)

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

  • 27

    Apr

  • 28

    Apr

  • 02

    May

CMCSA

Comcast

$38.79

0.3 (0.78%)

, CMCSK

Comcast

19:24
04/26/17
04/26
19:24
04/26/17
19:24
Hot Stocks
Comcast responds to FCC net neutrality news, says committed to open Internet »

Responding to FCC…

CMCSA

Comcast

$38.79

0.3 (0.78%)

CMCSK

Comcast

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

  • 27

    Apr

PCH

Potlatch

$46.50

1.25 (2.76%)

19:18
04/26/17
04/26
19:18
04/26/17
19:18
Earnings
Potlatch reports Q1 EPS 41c, consensus 20c »

Reports Q1 revenue…

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

  • 27

    Apr

DBOEY

Deutsche Boerse

$9.59

-0.005 (-0.05%)

19:13
04/26/17
04/26
19:13
04/26/17
19:13
Hot Stocks
Deutsche Boerse says plans EUR 200M repurchase program »

Deutsche Boerse 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

CBLI

Cleveland BioLabs

$3.64

-0.11 (-2.93%)

19:03
04/26/17
04/26
19:03
04/26/17
19:03
Hot Stocks
Cleveland BioLabs names John Szydlo principal financial officer »

According to a regulatory…

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

SU

Suncor

$30.62

-0.53 (-1.70%)

19:02
04/26/17
04/26
19:02
04/26/17
19:02
Hot Stocks
Suncor to repurchase up to C$2B of company's shares through NCIB »

Suncor announced plans 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

  • 27

    Apr

  • 27

    Apr

NBR

Nabors Industries

$11.74

-0.03 (-0.25%)

18:53
04/26/17
04/26
18:53
04/26/17
18:53
Earnings
Nabors Industries reports Q1 cont-op EPS with item (52c), consensus (35c) »

Reports Q1 revenue $563M,…

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

  • 27

    Apr

  • 01

    May

RTN

Raytheon

$155.27

-0.74 (-0.47%)

18:40
04/26/17
04/26
18:40
04/26/17
18:40
Hot Stocks
Raytheon awarded $375M U.S. Air Force contract »

The U.S. Air Force…

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

  • 27

    Apr

  • 31

    May

NOV

National Oilwell

$36.15

0.33 (0.92%)

18:38
04/26/17
04/26
18:38
04/26/17
18:38
Hot Stocks
National Oilwell reports Q1 book-to-bill of 41% for Rig Systems »

Backlog for capital…

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

  • 27

    Apr

  • 01

    May

  • 01

    May

OIS

Oil States

$32.10

-0.3 (-0.93%)

18:36
04/26/17
04/26
18:36
04/26/17
18:36
Earnings
Oil States reports Q1 adjusted EPS (34c), consensus (27c) »

Reports Q1 revenue…

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

  • 27

    Apr

  • 01

    May

PSA

Public Storage

$223.93

-1.61 (-0.71%)

18:35
04/26/17
04/26
18:35
04/26/17
18:35
Earnings
Public Storage reports Q1 core FFO $2.37, consensus $1.65 »

Reports Q1 revenue…

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

    Apr

  • 27

    Apr

NOV

National Oilwell

$36.15

0.33 (0.92%)

18:31
04/26/17
04/26
18:31
04/26/17
18:31
Earnings
National Oilwell reports Q1 adjusted EPS (17c), consensus (21c) »

Reports Q1 revenue…

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

  • 27

    Apr

  • 01

    May

  • 01

    May

PUB

People's Utah Bancorp

$27.55

-0.2 (-0.72%)

18:25
04/26/17
04/26
18:25
04/26/17
18:25
Hot Stocks
People's Utah Bancorp announces CEO succession in 2018 »

People's Utah…

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

  • 27

    Apr

  • 17

    May

BSFT

BroadSoft

$38.70

0.45 (1.18%)

18:17
04/26/17
04/26
18:17
04/26/17
18:17
Hot Stocks
BroadSoft announces agreement with Telstra for Australia communications »

BroadSoft announced 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

  • 27

    Apr

  • 09

    May

RJF

Raymond James

$75.74

0.55 (0.73%)

18:14
04/26/17
04/26
18:14
04/26/17
18:14
Earnings
Raymond James reports Q2 adjusted EPS $1.28, consensus $1.14 »

Reports Q2 GAAP EPS 77c.…

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

UCTT

Ultra Clean

$17.51

-0.2 (-1.13%)

, TER

Teradyne

$33.77

0.21 (0.63%)

18:14
04/26/17
04/26
18:14
04/26/17
18:14
Hot Stocks
On The Fly: After Hours Movers »

UP AFTER EARNINGS: Ultra…

UCTT

Ultra Clean

$17.51

-0.2 (-1.13%)

TER

Teradyne

$33.77

0.21 (0.63%)

CRY

CryoLife

$16.75

0.5 (3.08%)

ALSN

Allison Transmission

$37.47

0.53 (1.43%)

MKSI

MKS Instruments

$75.35

0.95 (1.28%)

AXTI

AXT, Inc.

$6.15

-0.25 (-3.91%)

PYPL

PayPal

$44.41

-0.3 (-0.67%)

GGG

Graco

$99.80

1.45 (1.47%)

NOW

ServiceNow

$90.92

0.68 (0.75%)

XLNX

Xilinx

$59.99

-0.7 (-1.15%)

WPG

Washington Prime

$8.92

-0.09 (-1.00%)

MMLP

Martin Midstream Partners

$19.55

-0.15 (-0.76%)

CAVM

Cavium

$70.93

-0.31 (-0.44%)

WLL

Whiting Petroleum

$8.07

-0.22 (-2.65%)

ROG

Rogers Corporation

$92.47

3.23 (3.62%)

INTU

Intuit

$115.81

-3.27 (-2.75%)

WTW

Weight Watchers

$20.16

1.33 (7.06%)

HRB

H&R Block

$23.89

-0.35 (-1.44%)

MLNX

Mellanox

$50.90

-0.05 (-0.10%)

FFIV

F5 Networks

$137.30

-0.89 (-0.64%)

CMPR

Cimpress

$86.25

-0.07 (-0.08%)

CTXS

Citrix

$84.12

0.07 (0.08%)

NTGR

Netgear

$51.35

-1.55 (-2.93%)

ETH

Ethan Allen

$31.25

0.15 (0.48%)

AMGN

Amgen

$164.61

-0.09 (-0.05%)

KN

Knowles

$19.59

0.04 (0.20%)

BWLD

Buffalo Wild Wings

$162.40

-0.4 (-0.25%)

ORLY

O'Reilly Automotive

$265.07

1.11 (0.42%)

SAM

Boston Beer

$141.85

-2.45 (-1.70%)

AMSC

AMSC

$7.70

0.3 (4.05%)

SFST

Southern First Bancshares

$33.05

0.25 (0.76%)

BRKL

Brookline Bancorp

$15.95

0.35 (2.24%)

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

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 26

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 27

    Apr

  • 28

    Apr

  • 02

    May

  • 02

    May

  • 02

    May

  • 03

    May

  • 03

    May

  • 04

    May

  • 04

    May

  • 09

    May

  • 09

    May

  • 09

    May

  • 10

    May

  • 11

    May

  • 16

    May

  • 17

    May

  • 30

    May

  • 31

    May

  • 07

    Jun

  • 12

    Jun

  • 15

    Jun

  • 20

    Jun

  • 21

    Jun

  • 21

    Jun

  • 22

    Jun

  • 22

    Jun

  • 19

    Jul

  • 14

    Aug

  • 27

    Apr

  • 27

    Apr

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.