In December 2015, Steminent received US FDA Orphan Drug Designation for Stemchymal ® in the treatment of PolyQ SCAs. The US FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics intended for both safe and effective treatment of rare indications that affect fewer than 200,000 people in the U.S.
The granted designation also allows Steminent to enjoy a 7-year market exclusivity upon approval of Stemchymal ® and other development incentives including tax credits for clinical research costs and Prescription Drug User Fee Act (PDUFA) fee exemption.
Stemchymal® is the proprietary, allogenicMSC product developed by Steminent for treatment of selected diseases with unmet or underserved medical needs.
The company’s SCA clinical study is now in the Phase II stage.