secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2026-02-23T23:59:59+00:00
Accession:  0001193125-26-062568
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Ultragenyx's BLA for DTX401 gene therapy for GSDIa with Priority Review, PDUFA Aug 23, 2026
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- FDA accepted Biologics License Application for DTX401 (pariglasgene brecaparvovec) to treat Glycogen Storage Disease Type Ia.
- Granted Priority Review; Prescription Drug User Fee Act (PDUFA) action date is August 23, 2026.
- DTX401 is an AAV-based gene therapy targeting a rare metabolic disorder with no approved therapies.
- BLA acceptance triggers regulatory milestone; company may be eligible for priority review voucher if approved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526062568/0001193125-26-062568-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526062568/rare-20260223.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-062568

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer