Ultragenyx secured FDA approval for Glenglycos, its one-time gene therapy for glycogen storage disease type Ia (GSDIa), marking the company’s first marketable gene therapy. The liver-targeted program delivers a functional gene intended to restore deficient enzyme activity that stabilizes blood sugar between meals. The FDA decision expands Ultragenyx to five approved products while bringing its gene-therapy portfolio into commercialization. Company officials said Glenglycos carries a per-patient wholesale acquisition cost of $2.7 million and is expected to be available within 30 to 60 days at specialized treatment centers. Ultragenyx also signaled capital-market implications through its priority review voucher plan, with management reiterating the therapy supports a path to profitability. Investors will now look to the company’s next major FDA catalysts, including UX111 and GTX-102.