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Stock Market & Financial Investment News

News Breaks
January 6, 2013
18:23 EDTVRTXVertex announces FDA grants the first two 'Breakthrough Therapy Designations'
Vertex announced that the U.S. Food and Drug Administration, FDA, granted the first two Breakthrough Therapy Designations to ivacaftor monotherapy and the combination regimen of VX-809 with ivacaftor for CF. Enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. FDASIA, Breakthrough Therapy Designation is intended to expedite the development and review of a potential new medicine if it is “intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”1
News For VRTX From The Last 14 Days
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January 29, 2015
10:00 EDTVRTXOn The Fly: Analyst Downgrade Summary
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09:16 EDTVRTXVertex downgraded at Maxim
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09:07 EDTVRTXHead researchers of Vertex, Regeneron, Merck invited to White House, CNBC says
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08:08 EDTVRTXVertex downgraded to Hold from Buy at Maxim
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06:58 EDTVRTXVertex downgraded to Hold from Buy at Needham
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January 28, 2015
18:21 EDTVRTXOn The Fly: After Hours Movers
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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
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