REGENXBIO Inc.
RGNX$536M
Small CapNASDAQBiological Products, (No Diagnostic Substances)🇺🇸North AmericaROCKVILLE
Clinical-stage biotechnology company developing AAV gene therapies
Drugs in Pipeline
0
Phase 3 Programs
0
Upcoming Catalysts
1
Next Catalyst
May 12, 2026
13wData is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply
Market Overview
Stock performance and market intelligence
Catalyst Timeline
2 upcoming, 1 past
🎯PDUFANext
FDA PDUFA Date RGX-121 (priority review)
2/8/2026
Gene therapy for Hunter syndrome. PDUFA date confirmed after FDA acceptance. For Hunter syndrome (MPS II).
Source🎯PDUFA
FDA PDUFA Date RGX-314 (priority)
5/12/2026
For wet age-related macular degeneration. BLA filing. Extracted from SEC filing: 8-K
SourceAI Predictions & Institutional Flow
Machine learning insights and smart money movement
FDA Submissions
Pending NDA/BLA submissions with predicted PDUFA dates
Drug Pipeline
Clinical development programs and drug candidates
Drug Pipeline
No drugs found in this phase.
Regulatory & News
Approvals, filings, and latest developments
Regulatory Approvals
RGNX News