Current Investment Highlights

  • Envarsus® (LCP-Tacro™) has successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002 by meeting its primary efficacy and primary safety endpoints
  • The company submitted in December 2013 a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® for the prevention of organ rejection in kidney transplant recipients
  • Envarsus® granted Orphan Drug Status by FDA 
  • The European Medicines Agency (EMA) has accepted for review the company's Marketing Authorization Application (MAA) to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union. Veloxis expects the decision from the European Union in 2014
  • Final STRATO clinical study data have demonstrated the potential for Envarsus® to improve tacrolimus-induced tremors in stable kidney transplant patients
  • Positive results of Envarsus® Phase III "Switch" Study, Study 3001
  • Exclusive distribution agreement with Chiesi Farmaceutici S.p.A for the commercialization and distribution of Envarsus® in certain countries, including Europe, Turkey and CIS countries

2013 Outlook

  • Veloxis is expecting an operating loss of DKK 60 - 90 million compared to the realized operating loss of DKK 136 million in 2013.

  • Net loss is expected to be in the range of DKK 55 - 85 million compared to the net loss of DKK 139 million in 2013.

  • As of 31 December 2013, the Company’s cash position equaled DKK 329 million and the Company’s 31 December 2014 cash position is expected to be in the range of DKK 230 - 270 million.

Veloxis Pharmaceuticals A/S (OMX : VELO) 16:59 on Feb 27, 2015
Last Price Change Open Day High 52-Week High
0.01 up  (0.90%) 1.11 1.13 2.30
Volume Previous Close Day Low 52-Week Low
1,443,509 1.11 1.10 0.76