OSE Immunotherapeutics, and its partner Veloxis Pharmaceuticals, have announced receipt of orphan drug designation (ODD) for VEL-101, which is in clinical development as a potential maintenance therapy for patients following kidney transplantation. This has several development and commercial advantages, including: tax credits for qualified clinical trials; exemption from user fees; and the potential for seven years of market exclusivity after approval. While this is a positive milestone, we note that Veloxis is responsible for the programme and, therefore, OSE has little control over how it runs.
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