Hot off a pair of key FDA green lights this summer, rare disease specialist Ultragenyx has wasted little time cashing in a pair of priority review vouchers it earned in the wake of the approvals.
On Wednesday, the company announced an agreement to sell a rare pediatric disease priority review voucher to an unnamed buyer for $203 million. Ultragenyx received the voucher following the September approval of Fayuvi, its second gene therapy to win an FDA nod this year and the first approved treatment for children with the rare genetic disorder Sanfilippo syndrome type A.
The transaction marks Ultragenyx's second PRV sale in just one week. On Oct. 7, the company disclosed an agreement to sell another rare pediatric disease PRV for $210 million to an undisclosed buyer. That voucher was awarded following the August approval of its gene therapy Genglycos for glycogen storage disease type Ia.
The latest PRV sale “delivers meaningful non-dilutive funding that strengthens our ability to provide innovative treatments for rare and ultra-rare diseases while supporting our objective of achieving profitability,” said Howard Horn, Ultragenyx’s finance chief and EVP for corporate strategy, in a statement.
Fayuvi itself benefited from capital Ultragenyx received as part of a previous FDA review voucher sale, which Horn said points to the “important role the PRV program plays in helping companies develop transformative therapies for rare disease patients.”
PRVs are awarded alongside certain FDA approvals, including those for rare pediatric diseases. The vouchers, which companies can also use themselves, allow drugmakers to shorten the FDA's standard 10-month review timeline to approximately six months. Selling PRVs to other companies is also a popular strategy for smaller drugmakers seeking an immediate financial return following approval.
The prices Ultragenyx secured in its two deals are toward the higher end of other PRV transactions announced in 2026.
In January, Jazz Pharmaceuticals said it had reached a $200 million deal to sell the PRV it secured with the 2025 approval of targeted brain cancer treatment Modeyso. The following month, Fortress Biotech agreed to sell a PRV for $205 million after its subsidiary Cyprium received the voucher following the January approval of copper replacement therapy Zycubo.
In late April, Rocket Pharmaceuticals also joined the PRV sale spree, selling the voucher it earned from the approval of its gene therapy Kresladi for leukocyte adhesion deficiency type 1 for $180 million.
The traditional PRVs that Ultragenyx, Jazz and others are trading appear to remain valuable for drugmakers hoping to accelerate the FDA review process.
The FDA introduced another option last year with its Commissioner's National Priority Voucher (CNPV) pilot program. Unveiled in June 2025 under former FDA Commissioner Martin Makary, M.D., the program aims to shorten review timelines even further for select drugs that address national priorities, including unmet medical needs, public health crises, innovation, domestic manufacturing and affordability.
Unlike traditional PRVs, however, CNPV vouchers cannot be transferred or sold to other companies.
The CNPV program has already yielded multiple FDA approvals in 2026.