EC grants ‘orphan medicinal product designation’ to Arcturus’ ARCT-032 for CF

Arcturus Therapeutics Holdings announced that the European Commission EC, based on a positive opinion issued by the European Medicines Agency, EMA , has granted orphan medicinal product designation for the Company’s product candidate ARCT-032 to treat Cystic Fibrosis CF . In November 2023, the U.S. Food and Drug Administration FDA granted orphan drug designation to ARCT-032 for CF. “We are pleased to receive orphan medicinal product designation from the EC for ARCT-032, as it represents a significant milestone for our CF program,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “We will continue to advance ARCT-032 as a potential new treatment option for people with CF regardless of their genetic mutations.” After successful completion of the single-ascending-dose portion of the study in healthy adults, the first participant with CF in the Phase 1b study part enrolled and completed two administrations of ARCT-032. Arcturus remains on track to share interim Phase 1b data in H1 2024.