Cytori Therapeutics Inc (NASDAQ:CYTX) announced that the US FDA Office of Orphan Products Development (OOPD) has granted Cytori an orphan drug designation for cryopreserved or centrally processed ECCS-50 for scleroderma.
“This orphan drug designation is part of our long-term strategy to facilitate the autologous retreatment of patients with scleroderma, if it is needed,” said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics. “Our development plan for cryopreserved ECCS-50 will be described in greater detail over the next few quarters.”
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and waivers from FDA user fees. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity for seven years. (Original Source)
Shares of Cytori are currently trading at $1.79, up $0.16 or 9.59%. CYTX has a 1-year high of $6.11 and a 1-year low of $1.50. The stock’s 50-day moving average is $1.97 and its 200-day moving average is $2.33.
On the ratings front, Maxim analyst Jason Kolbert reiterated a Buy rating on CYTX, with a price target of $5, in a report issued on November 10. The current price target implies an upside of 199% from current levels. According to TipRanks.com, Kolbert has a yearly average loss of 15.1%, a 27% success rate, and is ranked #4105 out of 4209 analysts.
Cytori Therapeutics, Inc. is a late stage cell therapy company. Its develops autologous cell therapies from adipose tissue, using its proprietary technology, to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell TherapyT acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.