Cytori Therapeutics Inc (NASDAQ:CYTX) announced that the European Commission has granted orphan drug status to a broad range of Cytori Cell Therapy® formulations when used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma.
Key benefits of this broad orphan drug designation include: (1) the ability to pursue multiple therapeutic formulations for systemic scleroderma that are not restricted to the processing of the adipose-derived cellular therapeutics at the bedside with the Celution® System or other current technology, (2) allows adipose-derived cellular therapeutics that are cryopreserved for later administration and (3) provides a pathway for Cytori to expeditiously seek conditional market approval in the EU.
“This broad orphan designation expands our strategic regulatory position and commercial options in Europe,” said Marc Hedrick, President and CEO of Cytori Therapeutics. “We intend to rely on this orphan designation, as well as long term safety and efficacy data from the SCLERADEC-I trial to seek conditional market authorization from the European Medicines Agency (EMA) on an accelerated timeline.”
“Orphan designation in Europe comes with significant benefits,” said Kenneth K. Kleinhenz, Vice President of Global Regulatory Affairs and Quality Assurance of Cytori Therapeutics. “These benefits include up to 10 years of market exclusivity if the medicine is authorized by the European Medicines Agency (EMA), access to the EMA’s conditional marketing authorization pathway (which is designed for orphan products that have initial clinical data and are actively in the process of completing their pivotal clinical studies), and an additional 10% reduction in regulatory fees beyond the reductions already afforded us because of our SME status. We believe the ECCS-50 therapy for scleroderma may benefit from these accelerated programs in Europe. This broad orphan designation will play a key role in our ability to fully access these programs.” (Original Source)
Shares of Cytori Therapeutics are up over 5% to $0.277 in pre-market trading. CYTX has a 1-year high of $0.75 and a 1-year low of $0.13. The stock’s 50-day moving average is $0.26 and its 200-day moving average is $0.25.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on March 28, Maxim Group analyst Jason Kolbert reiterated a Buy rating on CYTX, with a price target of $5, which implies an upside of 1801.1% from current levels. Separately, on March 24, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $1.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Joseph Pantginis have a total average return of -14.4% and -3.7% respectively. Kolbert has a success rate of 29.7% and is ranked #3824 out of 3828 analysts, while Pantginis has a success rate of 35.3% and is ranked #3663.