Following the announcement, Ultragenyx Pharmaceutical shares rose 13% to close at $14.50 on Thursday, with further gains pushing the stock to $14.78 in after-hours trading. Despite this recovery, the company’s stock remains down 37% for the year, largely due to recent setbacks involving disappointing Phase 3 results for its Angelman syndrome candidate, apazunersen.

Fayuvi, formerly known as UX111, represents the company’s second gene therapy approval and its sixth overall product clearance. Ultragenyx expects to begin shipping the treatment to qualified centers within the next 30 to 60 days. In addition to the approval, the company secured a priority review voucher, providing a strategic asset for its future development pipeline.