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RARE PDUFA Date: DTX401 AAV gene therapy (pariglasgene brecaparvovec)

FDA decision (PDUFA) target 2026-08-23 · Ultragenyx Pharmaceutical Inc. · Glycogen Storage Disease Type Ia (GSDIa)

RARE run-up into the PDUFA (last ~120 days)

$26.91$18.5
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-08-23
Drug / candidateDTX401 AAV gene therapy (pariglasgene brecaparvovec)
IndicationGlycogen Storage Disease Type Ia (GSDIa)
CompanyUltragenyx Pharmaceutical Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT03517085 · completed

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FAQ

When is the RARE PDUFA date?
The FDA PDUFA target date for RARE (Ultragenyx Pharmaceutical Inc.) is 2026-08-23 for DTX401 AAV gene therapy (pariglasgene brecaparvovec). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is RARE's drug DTX401 AAV gene therapy (pariglasgene brecaparvovec)?
DTX401 AAV gene therapy (pariglasgene brecaparvovec) is Ultragenyx Pharmaceutical Inc.'s candidate under FDA review for Glycogen Storage Disease Type Ia (GSDIa).
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.