AURA - Aura Biosciences receives Orphan Drug Designation for AU-011 for primary ocular melanoma

The European Commission has granted orphan drug designation to Aura Biosciences (NASDAQ:AURA) AU-011, a lead candidate for the treatment of uveal melanoma. The designation of uveal melanoma includes choroidal melanoma as well as melanomas of the iris and the ciliary body. Choroidal melanoma represents ~90% of uveal melanomas. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market. Aura's lead candidate AU-011 (belzupacap sarotalocan), a virus-like drug conjugate in phase 2 for chorodial melanoma, the most common type of intraocular cancer. AU-011 was previously granted Orphan Drug Designation for the treatment of uveal melanoma by the U.S. Food and Drug Administration.

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Aura Biosciences receives Orphan Drug Designation for AU-011 for primary ocular melanoma