Arcturus Therapeutics receives Orphan Drug Designation for ARCT-032 from FDA

Arcturus Therapeutics announced the FDA has granted Orphan Drug Designation for the company’s product candidate ARCT-032 to treat cystic fibrosis, or CF. The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, prevent, or diagnose a rare disease or condition affecting fewer than 200,000 people in the United States. The designation provides significant incentives to promote the development of the drug including the potential for market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act Application fee, and eligibility to receive regulatory guidance from the FDA in the design of an overall drug development plan.