New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 10, 2014
04:55 EDTEXEL, EXEL, EXEL, AGIO, AGIO, AGIO, ALNY, ALNY, ALNY, EPZM, EPZM, EPZM, INFO, INFO, INFO, VRTX, VRTX, VRTX, FMI, FMI, FMIBernstein to hold a conference
Emerging Biotech Conference 2014 is being held in Snowbird, Utah on March 10-12.
News For EXEL;AGIO;ALNY;EPZM;INFO;VRTX;FMI From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
May 18, 2015
07:37 EDTAGIOAgios Pharmaceuticals AG-120 granted FDA Fast Track designation
Subscribe for More Information
May 17, 2015
15:24 EDTALNYAlnylam files ALN-AAT trial application, reports positive results in primates
Subscribe for More Information
13:46 EDTVRTXVertex reports Orkambi data, says 'significant improvements' in primary endpoint
Vertex Pharmaceuticals announced that the New England Journal of Medicine published data from the two phase 3 studies of Orkambi, or lumacaftor/ivacaftor, a medicine designed to treat the underlying cause of cystic fibrosis in people ages 12 and older with two copies of the F508del mutation. In November 2014, Vertex submitted an NDA to the FDA for the combination of lumacaftor and ivacaftor. On May 12th, the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 12-1 to recommend approval of Orkambi for people ages 12 and older with two copies of the F508del mutation. The FDA is expected to make a decision by July 5. The New England Journal reports that the studies enrolled 1108 patients who underwent randomization and received Orkambi. In both studies, there were significant improvements in the primary end point in both lumacaftor–ivacaftor dose groups. The difference between active treatment and placebo with respect to the mean absolute improvement in the percentage of predicted FEV ranged 2.6%-4%, which corresponded to a mean relative treatment difference of 4.3 to 6.7%. Pooled analyses showed that the rate of pulmonary exacerbations was 30%-39% lower than in the placebo group. The rate of events leading to hospitalization or the use of intravenous antibiotics was also lower. The incidence of adverse events was generally similar to the placebo group.
May 15, 2015
09:31 EDTVRTXAmerican Thoracic Society to hold a conference
ATS 2015 Conference is being held in Denver on May 15-20.
May 13, 2015
07:28 EDTFMIFoundation Medicine price target lowered to $48-52 from $60-65 at Wells Fargo
Subscribe for More Information
07:19 EDTVRTXVertex shares should have upward momentum in near-term, says JMP Securities
Subscribe for More Information
07:06 EDTFMIFoundation Medicine announces new data on FoundationOne assay
Subscribe for More Information
May 12, 2015
17:54 EDTVRTXOn The Fly: After Hours Movers
Subscribe for More Information
16:49 EDTVRTXVertex resumes after-hours trading, shares up 5.6% to $131.00
Subscribe for More Information
16:20 EDTVRTXVertex to resume trading at 14:45
16:19 EDTVRTXVertex confirms FDA panel voted 12-to-1 to recommend approval of Orkambi
Subscribe for More Information
16:16 EDTVRTXVertex confirms FDA panel voted 12-to-1 to recommend approval of Orkambi
16:16 EDTVRTXPiper Jaffray remains confident in approval for Vertex
Subscribe for More Information
15:43 EDTVRTXFDA panel votes 12 to 1 that data supports Orkambi approval
Subscribe for More Information
15:35 EDTVRTXFDA panel votes unanimously that data support Orkambi safety
Subscribe for More Information
15:32 EDTVRTXFDA panel inconclusive on if Lumacaftor contributes to Orkambi effectiveness
Subscribe for More Information
10:23 EDTVRTXVertex shares halted while FDA panel meeting takes place
08:20 EDTFMIFoundation Medicine weakness creates buying opportunity, says JMP Securities
Subscribe for More Information
07:58 EDTVRTXFDA Pulmonary-Allergy Drugs Advisory Committee to hold a meeting
Subscribe for More Information
07:52 EDTEPZM, ALNY, AGIOLeerink to hold a tour
Subscribe for More Information
1 | 2 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use