Posted by Michael Wonder on 04 Mar 2026
SpliSense granted EMA EARLY PRIME designation for SPL84 in cystic fibrosis
3 March 2026 - SpliSense today announced that the EMA has granted early Priority Medicines (e-PRIME) designation to SPL84 for the treatment of cystic fibrosis in patients carrying the 3849+10Kb C>T mutation in the CFTR gene.
The e-PRIME designation builds also on the positive results previously reported from the Phase 2 (SPL84-002) study.
