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Ultragenyx Agrees to Sell FDA Priority Review Voucher for $203 Million

BullishMedium impact
RARE$15.00 0.54%

Ultragenyx Pharmaceutical, Inc. (NASDAQ:RARE) has reached a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher for $203 million. The company earned the voucher after the U.S. Food and Drug Administration approved Fayuvi, also known as rebisufligene etisparvovec, in September to treat children with Sanfilippo syndrome type A.

The sale provides Ultragenyx with non-dilutive capital shortly after completing a similar transaction. Earlier this month, the biotechnology company agreed to sell another priority review voucher for $210 million following the approval of its rare disease treatment Genglycos. Under the FDA program, vouchers grant accelerated review timelines for subsequent drug marketing applications in the United States.

Completion of the $203 million transaction remains subject to customary closing conditions. Investors will be watching for the formal closing of both voucher sales and how the company utilizes the combined cash proceeds to support its rare disease development pipeline.

Key points

  • Ultragenyx Pharmaceutical agreed to sell an FDA priority review voucher for $203 million.
  • The voucher was awarded following the September FDA approval of Fayuvi for Sanfilippo syndrome type A.
  • This marks the company's second voucher sale this month, following a $210 million deal for its Genglycos voucher.
  • The transaction remains subject to customary closing conditions.

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Questions and answers

Why did Ultragenyx receive an FDA priority review voucher?

Ultragenyx received the voucher following the FDA approval of Fayuvi, a gene therapy approved in September to treat children with Sanfilippo syndrome type A.

How much is Ultragenyx selling the priority review voucher for?

Ultragenyx agreed to sell the Rare Pediatric Disease Priority Review Voucher for $203 million, subject to customary closing conditions.

How many priority review vouchers has Ultragenyx sold recently?

This deal is Ultragenyx's second voucher sale this month, following an agreement to sell another voucher for $210 million received for its therapy Genglycos.