New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 4, 2014
08:01 EDTVRTXVertex reports improvement in lung function in proof-of-concept ivacaftor study
Vertex Pharmaceuticals announced the results of a two-part proof-of-concept study of ivacaftor in 24 people with cystic fibrosis who have a residual function mutation. The first part of the study evaluated ivacaftor, compared with placebo, in a two-week crossover design over two treatment cycles, and the second part of the study evaluated ivacaftor in an eight-week open-label design. In part one, a statistically significant improvement in mean absolute lung function was observed after treatment with ivacaftor for two weeks compared with placebo. In part two of the study, improvements in lung function were observed after eight weeks of treatment. In the study, ivacaftor was generally well-tolerated, and the most common adverse events in the treatment group were cough and respiratory tract infection. This proof-of-concept study was the first to evaluate the use of ivacaftor in multiple residual function mutations and is supported by in vitro observations that showed ivacaftor enhanced the function of the cystic fibrosis transmembrane conductance regulator protein in cells with residual function mutations. Based on these data, Vertex plans to initiate a larger Phase 3 study in people with residual function mutations that will evaluate longer-duration treatment with ivacaftor, pending discussions with regulatory authorities.
News For VRTX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 30, 2015
06:34 EDTVRTXObama to propose $215M for major medical program, CNBC says
Subscribe for More Information
January 29, 2015
10:00 EDTVRTXOn The Fly: Analyst Downgrade Summary
Subscribe for More Information
09:16 EDTVRTXVertex downgraded at Maxim
Subscribe for More Information
09:07 EDTVRTXHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
Subscribe for More Information
08:08 EDTVRTXVertex downgraded to Hold from Buy at Maxim
Subscribe for More Information
06:58 EDTVRTXVertex downgraded to Hold from Buy at Needham
Subscribe for More Information
January 28, 2015
18:21 EDTVRTXOn The Fly: After Hours Movers
Subscribe for More Information
16:07 EDTVRTXVertex sees FY15 KALYDECO net revenues $560M-$580M
FY15 revenue consensus $1.19B. KALYDECO net revenues reflect use of KALYDECO by eligible patients in Australia following the completion of reimbursement discussions in late 2014; use of KALYDECO in some people in the United States with the R117H mutation following FDA approval in late 2014; the completion of reimbursement discussions for gating mutations in certain European countries; and use of KALYDECO in children with CF ages 2 to 5 with the G551D or other gating mutations in the United States, based on potential approval in March 2015. Vertex expects that its combined non-GAAP R&D and SG&A expenses in 2015 will be in the range of $1.05B-$1.1B. The increase as compared to 2014 is primarily a result of launch preparation activities for lumacaftor in combination with ivacaftor and the planned pivotal Phase 3 development program for VX-661 in combination with ivacaftor.
16:05 EDTVRTXVertex reports Q4 adjusted EPS (55c), consensus (65c)
Reports Q4 revenue $145M, consensus $137.49M. Reports Q4 revenues of $124M from KALYDECO in CF.
15:37 EDTVRTXNotable companies reporting after market close
Subscribe for More Information

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