RGNX
REGENXBIO Inc.
FDA PDUFA Target Action Date
Sunday, February 8, 2026
107 days ago
Complete Response Letter Drug Information
- Application Type
- BLA
- FDA Designations
- Priority ReviewOrphan Drug
- Indication
- Mucopolysaccharidosis Type II (Hunter syndrome)
- Approved As
- RGX-121 (clemidsogene lanparvovec)
Filing Details
- Company
- REGENXBIO Inc.
- Stock Ticker
- RGNX
- SEC CIK
- 0001590877
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue