Current Investment Highlights
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Enrolment completed in the pivotal LCP-Tacro™ Phase III study in de novo kidney transplant patients. Results from this study are expected mid-2013
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Positive results of LCP-Tacro Phase III "Switch" Study
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Exclusive distribution agreement with Chiesi Farmaceutici S.p.A for the commercialization and distribution of LCP-Tacro™ in certain countries, including Europe, Turkey and CIS countries
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Submission of marketing authorization Application (MAA) in April 2013 to the European Medicines Agency (EMA) seeking approval to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union
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Financing in place to support development, differentiation and commercialization activities through initial launch of LCP-Tacro
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Full organizational focus on the completion of the development and subsequent commercialization of LCP-Tacro™
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Preliminary analysis of the STRATO Phase lllb study suggests reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro™
Expected 2013 Milestones
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Veloxis anticipates releasing final results from its STRATO tremor study in May 2013
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The pivotal study results from the 3002 kidney transplant study are on target for release in mid-2013 with expected NDA filing with the FDA in the second half of 2013. If successful, and if approved by EMA and FDA, commercialization of LCP-Tacro could begin by approximately the fourth quarter 2014
| Veloxis Pharmaceuticals A/S (OMX : VELO) |
15:57 on Jun 18, 2013 |
| Last Price |
Change |
Open |
Day High |
52-Week High |
0.60 |
0.01
(1.64%) |
0.60 |
0.62 |
0.72 |
| Volume |
Previous Close |
Day Low |
52-Week Low |
| 288,418 |
0.61 |
0.59 |
0.32 |
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