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Ultragenyx agrees to sell review voucher for $210M

The agreed $210 million cash payment is due upon closing; after closing, Ultragenyx will pay NIH 20% of the PRV sale’s gross proceeds.

(Moderate)

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Form Type
8-K

Rhea-AI Filing Summary

Ultragenyx Pharmaceutical Inc. (RARE) entered into an agreement on October 6, 2026, to sell a Rare Pediatric Disease Priority Review Voucher (PRV). The buyer agreed to pay $210 million in cash upon closing. Under a patent license agreement dated December 10, 2018, Ultragenyx will pay NIH 20% of the gross proceeds from the PRV sale after closing.

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. FDA awarded Ultragenyx the PRV on August 19, 2026, upon approval of GENGLYCOS (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with glycogen storage disease type Ia. The agreement includes customary representations, warranties, covenants and indemnification provisions, subject to certain limitations.

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.
Cash purchase price $210 million Payable by the buyer upon closing
Gross proceeds payable to NIH 20% Ultragenyx will pay this share after closing
Agreement date October 6, 2026 Date Ultragenyx entered into the PRV Asset Purchase Agreement
PRV award date August 19, 2026 FDA award upon GENGLYCOS approval
Minimum patient age 8 years GENGLYCOS approval was for patients eight years and older
Rare Pediatric Disease Priority Review Voucher regulatory
"sell a Rare Pediatric Disease Priority Review Voucher"
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
"waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976"
GSDIa medical
"glycogen storage disease type Ia (GSDIa)"
pariglasgene brecaparvovec-opnr medical
"GENGLYCOS (pariglasgene brecaparvovec-opnr)"

FAQ

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

How much is Ultragenyx (RARE) selling its PRV for?

The buyer agreed to pay Ultragenyx $210 million in cash upon closing of the PRV sale.

How much of the RARE PRV sale proceeds will go to NIH?

Ultragenyx will pay NIH 20% of the gross proceeds after closing, under a patent license agreement dated December 10, 2018.

What indication was GENGLYCOS approved for when RARE received the PRV?

The FDA awarded the PRV on August 19, 2026, upon approval of GENGLYCOS in adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa).

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

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Learn about SEC filing dates
0001515673false00015156732026-10-062026-10-06

 

 

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 06, 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 6, 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 August 19, 2026 upon approval of GENGLYCOS™ (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa). Pursuant to the PRV Asset Purchase Agreement, the buyer agreed to pay the Company $210 million, payable in cash, upon the closing of the transaction. Pursuant to the terms of a patent license agreement with the U.S. Department of Health (the “NIH”) dated December 10, 2018, 20% of the gross proceeds from the sale of the PRV will be payable by the Company to the NIH after 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 7, 2026

By:

/s/ Howard Horn

 

 

 

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

 

 


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