FDA Approval of Ultragenyx Gene Therapy Triggers ABEONA Royalties

Abeona is eligible for commercial milestone payments and royalties after the FDA approved FAYUVI, the Sanfilippo type A gene therapy it out-licensed in 2022.

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Abeona Therapeutics developed the Sanfilippo type A gene therapy before out-licensing it in 2022.

Abeona Therapeutics (ABEO) said the U.S. Food and Drug Administration has approved FAYUVI (rebisufligene etisparvovec-hopf), also known as UX111, a gene therapy from Ultragenyx Pharmaceutical for patients with Sanfilippo syndrome type A, or MPS IIIA. The program originated at Abeona, which advanced it through early clinical development as ABO-102 before out-licensing global rights to Ultragenyx in May 2022. Under that agreement, Abeona is eligible to receive certain commercial milestone payments and royalties tied to future product sales.