New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 14, 2012
09:05 EDTCYTXCytori Therapeutics 7.02M share Spot Secondary priced at $2.85
Lazard Capital acted as sole book running manager for the offering.
News For CYTX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
April 13, 2015
08:03 EDTCYTXCytori provides twelve month data update on Scleradec-I trial
Subscribe for More Information
April 8, 2015
15:00 EDTCYTXCytori CEO spinning 'fairy-tale story' to support company, TheStreet says
Subscribe for More Information
April 7, 2015
08:02 EDTCYTXCytori Therapeutics granted orphan drug status for cellular therpeutic in EU
Cytori Therapeutics announced that the European Commission, acting on the positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, has designated Cytori’s ECCS-50 cellular therapeutic as an orphan medicinal product for the treatment of scleroderma. This designation marks the first autologous adipose derived cell therapy for scleroderma granted orphan status in the European Union. Cytori is currently working with leading scleroderma centers in France led by the Assistance Publique des Hôpitaux de Marseille to begin a 40 patient EU pivotal trial called SCLERADEC-II. The trial is a follow-up controlled trial to the first SCLERADEC trial published last August. If successful, this trial would potentially lead to EMA approval of Cytori’s lead therapeutic for this indication in the EU, as an ATMP or Advanced Therapy Medicinal Product. Cytori recently received FDA approval for a phase 3 clinical trial with our ECCS-50 therapeutic in 80 patients with scleroderma associated hand dysfunction. This US clinical trial is currently planned to begin enrolling this year and has recently been granted FDA approval to expand the number of centers from 12 to 20 sites. This US clinical data could also be useful to support regulatory approvals and reimbursement in the EU as well as other global markets.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use