The U.S. Food and Drug Administration granted orphan drug status to Cynata Therapeutics Ltd.'s stem cell therapy CYP-001.
The drug is meant to treat the acute graft versus host disease, which occurs after transplant procedures when immune cells from transplanted tissue attack the recipient. The disease has a high mortality rate.
The orphan drug status will help expedite development of CYP-001 and entitles Cynata to seven years of exclusive market rights and tax credits once the treatment is commercialized.
CYP-001 is being studied in an early stage trial.