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Home › PDUFA Calendar › ABEO

ABEO PDUFA Date: UX111

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on September 17, 2026, 2 days before its September 19, 2026 goal date. Decision page with the source and measured reaction.
FDA decision Approved September 17, 2026 · Abeona Therapeutics Inc. · Sanfilippo syndrome type A (MPS IIIA)
More CNS & Neurology FDA decisions →All September 2026 PDUFA dates →

The story

UX111 was approved by the FDA on September 17, 2026 to treat Sanfilippo syndrome type A (MPS IIIA) - a fatal childhood neurodegenerative disease.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthNVO-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)

$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 decisionApproved September 17, 2026
FDA goal 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

What did the FDA decide on ABEO's UX111?
The FDA decided ABEO's (Abeona Therapeutics Inc.) application for UX111 on September 17, 2026: Approved. The FDA goal date for this application was 2026-09-19. Verify against the linked primary source.
What is ABEO's drug UX111?
UX111 is Abeona Therapeutics Inc.'s drug, approved by the FDA on September 17, 2026 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
under -30%: 5 of 274 (2%)<-30-30 to -15%: 10 of 274 (4%)-15 to -7%: 25 of 274 (9%)-7 to -3%: 36 of 274 (13%)-3 to +3%: 131 of 274 (48%)±3+3 to +7%: 30 of 274 (11%)+7 to +15%: 21 of 274 (8%)+15 to +30%: 10 of 274 (4%)over +30%: 6 of 274 (2%)>+30
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.