# RARE PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/RARE
Company: Ultragenyx Pharmaceutical

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with RARE.

## RARE PDUFA Milestones

- 2025-07-11 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for UX111 (rebisufligene etisparvovec) on July 11, 2025....
  Company: Ultragenyx Pharmaceutical
  Source: https://www.sec.gov/Archives/edgar/data/1515673/000095017025095334/rare-20250711.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/RARE/ux111-rebisufligene-etisparvovec-ux111-bla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/july (July 2025)
- 2026-08-23 — PDUFA — Original PDUFA date superseded by early approval. FDA had assigned August 23 as the PDUFA target action date for the DTX401 BLA. The agency granted accelerat...
  Company: Ultragenyx Pharmaceutical
  Source: https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-and-priority-review
  Event detail: https://biopharmsignal.com/pdufa-calendar/RARE/dtx401-glycogen-storage-disease-type-ia.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)
- 2026-09-19 — PDUFA — FDA decision expected. FDA assigned a September 19, 2026 PDUFA action date to the resubmitted BLA seeking accelerated approval for UX111.
  Company: Ultragenyx Pharmaceutical
  Source: https://ir.ultragenyx.com/node/18781
  Event detail: https://biopharmsignal.com/pdufa-calendar/RARE/ux111-sanfilippo-syndrome-type-a-review-2.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/RARE
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the RARE PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with RARE, including decision dates, application stage, and summary details when available.
### Where can I find more context for RARE?

Use the BioPharmSignal company page for RARE to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.