Boston, MA, 06/28/2013 (financialstrend) – Dendreon Corporation (NASDAQ:DNDN) is trading currently at $4.24 after moving 3.68% ($0.16) northwards. The intra-day range of the stock is $4.22-$4.49. About 5.86 million shares are traded till now and 4.63 million shares are traded on an average in 30 days.
The company, Dendreon Corporation, has announced recently that the EMA (European Medicines Agency) CHMP (Committee for Medicinal Products for Human Use) has given a positive opinion saying that PROVENGE, an autologous peripheral blood mononuclear cells that are activated with Sipuleucel-T or PAP-GM-CSF, will be granted the marketing authorization in the EU (European Union). These cells can be used for the treatment of minimally symptomatic or asymptomatic metastatic (non-visceral) castrate resistant prostate cancer which affects male adults, in whom the chemotherapy is not yet clinically indicated.
The recommendation of Committee for Medicinal Products for Human Use (CHMP) follows a positive recommendation by CAT (Committee for Advanced Therapy).
The Chief Medical Officer and the Executive Vice President of Research and Development, Mark Frohlich, said that they are very glad at this outcome and are looking forward to a final regulatory decision that will be taken by the European Commission by the end of this year. PROVENGE is a novel therapy which uses the immune system of the body in order to fight cancer. It addresses a genuine un-met need of the patient. PROVENGE would help in extending the lives of the people in Europe, who have appropriate prostate cancer, if it is approved.
Within the coming months, a final recommendation would be made to the European Commission (EC) by the CHMP on the application of marketing authorization for PROVENGE in EU. In the second half of this year, the regulatory decision is expected from EC.
PROVENGE is the first immunotherapy that has demonstrated an overall improvement in the field of prostate cancer. Hence, it is great news for the patients and physicians in Europe.