December 2025
Telomere Therapeutics has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for AAV-TERT-01, its investigational gene therapy for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
The designation recognizes the potential of AAV-TERT-01 to address a rare disease with significant unmet medical need and provides regulatory incentives to support its continued development, including protocol assistance, fee reductions, and, subject to marketing approval, up to ten years of market exclusivity in the European Union.