secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2026-04-02T23:59:59+00:00
Accession:  0001193125-26-139084
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts resubmitted BLA for UX111 gene therapy; PDUFA date Sept 19, 2026
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- FDA accepted for review resubmitted BLA for UX111 (rebisufligene etisparvovec) AAV9 gene therapy.
- UX111 is intended for Sanfilippo syndrome Type A (MPS IIIA) under accelerated approval pathway.
- PDUFA action date set for September 19, 2026.
- No new safety or efficacy data disclosed; review outcome remains uncertain.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526139084/0001193125-26-139084-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000119312526139084/rare-20260402.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-139084

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