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Stock Market & Financial Investment News

News Breaks
June 30, 2014
16:07 EDTVRTXVertex submits sNDA to FDA for Kalydeco
Vertex Pharmaceuticals announced the submission of a supplemental New Drug Application, or sNDA, to the FDA for the approval of Kalydeco in people with cystic fibrosis, or CF, ages 18 and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator, or CFTR, gene. In the United States, Kalydeco is currently approved for use in people with CF ages 6 and older who have one of the following nine mutations: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D. CF is caused by a defective or missing CFTR protein that results from mutations in the CFTR gene. In the United States, approximately 300 people have the R117H mutation and are 18 years of age or older. R117H is the most common residual function mutation and also has a defect in the gating of the CFTR protein.
News For VRTX From The Last 14 Days
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January 30, 2015
06:34 EDTVRTXObama to propose $215M for major medical program, CNBC says
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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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