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Ultragenyx to sell FDA review voucher for $203M

The agreement calls for $203 million in cash at closing, with completion subject to customary conditions and the applicable HSR waiting period.

(Moderate)

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Form Type
8-K

Rhea-AI Filing Summary

On October 8, 2026, Ultragenyx Pharmaceutical Inc. entered into an asset purchase agreement to sell a Rare Pediatric Disease Priority Review Voucher for $203 million in cash, payable upon closing. The FDA awarded the voucher on September 17, 2026, upon approval of UX111 (rebisufligene etisparvovec-hopf) for pediatric patients with MPS IIIA, or Sanfilippo syndrome Type A. The transaction remains subject to customary closing conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
PRV sale price $203 million Cash payable upon closing
PRV asset purchase agreement date October 8, 2026 Date Ultragenyx entered into the agreement
PRV award date September 17, 2026 Awarded upon FDA approval of UX111
Rare Pediatric Disease Priority Review Voucher regulatory
"sell a Rare Pediatric Disease Priority Review Voucher (“PRV”) to the buyer"
A rare pediatric disease priority review voucher is a transferable regulatory benefit awarded to a company that wins approval for a drug treating a serious but uncommon childhood illness. It works like a “fast-pass” with regulators: the holder can use it to get an accelerated review of a future drug application or sell the voucher to another company, often for a large sum. Investors care because it can speed time to market or generate immediate cash, boosting potential returns and lowering risk on other programs.
Hart-Scott-Rodino Antitrust Improvements Act of 1976 regulatory
"the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976"
mucopolysaccharidosis type IIIA medical
"treatment of pediatric patients with mucopolysaccharidosis type IIIA"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much is Ultragenyx selling its PRV for?

Ultragenyx agreed to sell the Rare Pediatric Disease Priority Review Voucher for $203 million in cash, payable upon closing. The transaction remains subject to customary closing conditions, including the applicable Hart-Scott-Rodino waiting period.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false000151567300015156732026-10-082026-10-08

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 08, 2026

 

 

Ultragenyx Pharmaceutical Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36276

27-2546083

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

60 Leveroni Court

 

Novato, California

 

94949

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 415 483-8800

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 par value

 

RARE

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 


 

Item 1.01

Entry into a Material Definitive Agreement.

 

On October 8, 2026, Ultragenyx Pharmaceutical Inc. (the “Company”) entered into an asset purchase agreement (the “PRV Asset Purchase Agreement”), pursuant to which the Company agreed to sell a Rare Pediatric Disease Priority Review Voucher (“PRV”) to the buyer. The Company was awarded the PRV by the U.S. Food and Drug Administration (“FDA”) on September 17, 2026 upon approval of FAYUVITM (rebisufligene etisparvovec-hopf) also known as UX111, for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome Type A). Pursuant to the PRV Asset Purchase Agreement, the buyer agreed to pay the Company $203 million, payable in cash, upon the closing of the transaction.

The PRV Asset Purchase Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The foregoing description of the PRV Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Asset Purchase Agreement, a copy of which will be filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2026.

 

 


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Ultragenyx Pharmaceutical, Inc.

 

 

 

 

Date:

October 14, 2026

By:

/s/ Howard Horn

 

 

 

Howard Horn
Executive Vice President, Chief Financial Officer, Corporate Strategy

 

 


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