ABEO PDUFA Date: UX111

Name: UX111 FDA decision
Start: 2026-09-19
End: 2026-09-19

Updated August 7, 2026·next FDA decision on the calendar

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

More CNS & Neurology FDA decisions →All September 2026 PDUFA dates →

The story

UX111 is under FDA review to treat Sanfilippo syndrome type A (MPS IIIA) - a fatal childhood neurodegenerative disease.

Full PDUFA calendar ->Every upcoming FDA decision date, by month NVO-sogroya . 2026-06-30Same area: Rare / Genetic . Sogroya (somapacitan)REGN-otoferlin-gene-therapy . 2026-06-30Same area: Rare / Genetic . Otoferlin gene therapy (DB-OTO)TLX . 2026-09-11Same month decision . TLX101-Px

Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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

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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See the full 2026 PDUFA calendar →

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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.

Decision-day move · small-cap cohortn=274 · median +0.0% · 49% up

Distribution of next-day % moves after the FDA decision for small-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.