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ABEO PDUFA Date: UX111

FDA decision (PDUFA) target 2026-09-19 · Abeona Therapeutics Inc. · Sanfilippo syndrome type A (MPS IIIA)

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

$6.01$4.23
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-19
Drug / candidateUX111
IndicationSanfilippo syndrome type A (MPS IIIA)
CompanyAbeona Therapeutics Inc.
Market-cap tierSmall
Cohort decision-day move (history)±3% median
ClinicalTrials.govNCT02716246 · recruiting

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FAQ

When is the ABEO PDUFA date?
The FDA PDUFA target date for ABEO (Abeona Therapeutics Inc.) is 2026-09-19 for UX111. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is ABEO's drug UX111?
UX111 is Abeona Therapeutics Inc.'s candidate under FDA review for Sanfilippo syndrome type A (MPS IIIA).
What typically happens to a small-cap stock into a PDUFA date?
Historically, small-cap names had a median decision-day move around ±3% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.