Ultragenyx Pharmaceutical Inc. 8-K Filing
Ticker: RARE · Form: 8-K · Filed: Dec 30, 2025 · CIK: 1515673
| Field | Detail |
|---|---|
| Company | Ultragenyx Pharmaceutical Inc. (RARE) |
| Form Type | 8-K |
| Filed Date | Dec 30, 2025 |
| Pages | 3 |
| Reading Time | 4 min |
| Key Dollar Amounts | $0.001 |
| Sentiment | neutral |
Sentiment: neutral
FAQ
What type of filing is this?
This is a 8-K filing submitted by Ultragenyx Pharmaceutical Inc. (ticker: RARE) to the SEC on Dec 30, 2025.
What are the key financial figures in this filing?
Key dollar amounts include: $0.001 (nge on which registered Common Stock, $0.001 par value RARE Nasdaq Global Select).
How long is this filing?
Ultragenyx Pharmaceutical Inc.'s 8-K filing is 3 pages with approximately 1,001 words. Estimated reading time is 4 minutes.
Where can I view the full 8-K filing?
The complete filing is available on SEC EDGAR. You can also read the AI-decoded analysis with risk assessment and key highlights on ReadTheFiling.
Filing Stats: 1,001 words · 4 min read · ~3 pages · Grade level 18.4 · Accepted 2025-12-30 16:11:26
Key Financial Figures
- $0.001 — nge on which registered Common Stock, $0.001 par value RARE Nasdaq Global Select
Filing Documents
- rare-20251230.htm (8-K) — 49KB
- 0001193125-25-337099.txt ( ) — 150KB
- rare-20251230.xsd (EX-101.SCH) — 23KB
- rare-20251230_htm.xml (XML) — 4KB
01 Other Events
Item 8.01 Other Events. On December 30, 2025, Ultragenyx Pharmaceutical Inc. (the "Company") issued a press release announcing that that it has completed the rolling submission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration (the "FDA") seeking approval for DTX401 AAV gene therapy (pariglasgene brecaparvovec) as a treatment for Glycogen Storage Disease Type Ia ("GSDIa"). The BLA for DTX401 is based on data from a clinical development program that includes 52 treated patients and up to six years of follow-up. Previously announced data from the randomized, double-blind, placebo-controlled Phase 3 GlucoGene study demonstrate that patients treated with DTX401 experienced significant and clinically meaningful reductions in both the quantity and frequency of daily cornstarch intake while maintaining low levels of hypoglycemia, improved levels of euglycemia, and improved fasting tolerance. These clinical benefits translated to meaningful improvements in patient-reported quality of life, as measured by the Patient Global Impression of Change scale. DTX401 was well tolerated with an acceptable safety profile. The Company was previously granted rolling review and submitted the non-clinical and clinical modules to the FDA in August 2025 and has now completed the package through submission of the chemistry, manufacturing and controls module. Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, "anticipates," "continue," "will," or other similar terms or expressions that concern the Company's expectations, plans and intentions. Forward-looking statements include, without limitation, statements related to the Company's expectations and projections regarding its future operating results and financial performance
SIGNATURES
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: December 30, 2025 By: /s/ Howard Horn Howard Horn Executive Vice President, Chief Financial Officer, Corporate Strategy