“Voluntary Withdrawal of Orphan Drug Designation for obe-cel in the European Union
As previously reported, in March 2022, our product obe-cel received European Commission orphan drug designation. In June 2025, we met with the European Medicines Agency’s Committee for Orphan Medicinal Products, which is responsible for assessing continued eligibility for EU orphan drug designation. Following such meeting, in June 2025, we voluntarily withdrew obe-cel from the EU register of orphan medicinal products. In July 2025, following a thorough evaluation of the commercial viability of marketing obe-cel in the European Union without an orphan designation, as well as the challenges associated with the framework of pricing policies for advanced cell therapies within the European Union and the potential impact of proposed most favored nations pricing policies in the United States, we put the launch of obe-cel in Germany on hold. Evaluation of potential pricing and feasibility of market entry opportunities is ongoing.”
