Organization (Industry)
ABEONA THERAPEUTICS INC.
ClinicalTrials.gov lists ABEONA THERAPEUTICS INC. as lead sponsor of 11 trials. It has 4 active development programs and 3 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers ABEONA THERAPEUTICS INC.: 11 lead-sponsored trials and 2 legal-entity registrations.
Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.
Disease areas (22)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Epidermolysis Bullosa | 5 |
| Epidermolysis Bullosa Dystrophica | 5 |
| Mucopolysaccharidosis III | 4 |
| Diabetes Mellitus | 2 |
| Diabetic Foot | 2 |
Showing 5 of 22 disease areas.
Trials by start year as sponsor or collaborator (11)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 1 |
| 2023 | 1 |
| 2021 | 1 |
| 2020 | 2 |
| 2019 | 1 |
| 2017 | 1 |
| 2016 | 1 |
| 2010 | 1 |
| 2006 | 1 |
Showing 10 of 11 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (4)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| EB-101 Surgical application of RDEB wounds | Epidermolysis Bullosa | Phase 3 | 1 |
| EB-101 Surgical application of RDEB wounds | Epidermolysis Bullosa Dystrophica | Phase 3 | 1 |
| LZRSE-Col7A1 Engineered Autologous Epidermal Sheets | Epidermolysis Bullosa | Phase 1/2 | 1 |
| LZRSE-Col7A1 Engineered Autologous Epidermal Sheets | Epidermolysis Bullosa Dystrophica | Phase 1/2 | 1 |
Approved assets (3)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Pz-cel surgical application to DEB wounds | 1 |
| Non-conforming pz-cel surgical application to RDEB wounds | 1 |
| Ofloxacin | 2 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 60% hit target (n=5) | 2 of 4 on time (n=4) |
Journals published in (25)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Acta paediatrica (Oslo, Norway : 1992) | 2 |
| Human gene therapy. Clinical development | 2 |
| AJR. American journal of roentgenology | 1 |
| Acta neuropathologica | 1 |
| Annals of the New York Academy of Sciences | 1 |
Showing 5 of 25 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 40 | 2 | 2025-10-28 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 1 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Abeona Therapeutics Inc. | Cleveland, US | FDA |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (4)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Ultragenyx Pharmaceutical Inc. | Co sponsors trial with | 2 |
| Stanford University | Co sponsors trial with | 1 |
| Government of the United States of America | Co sponsors trial with | 1 |
| M.D. Anderson Cancer Center | Co sponsors trial with | 1 |
Latest dated events (62)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2027 | PDUFA decision date | Regulatory decision dates extracted from SEC filings |
| 2026-11 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-10-28 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-07-25 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-04-28 | PDUFA decision date | Regulatory decision dates extracted from SEC filings |
Showing 5 of 62 events.
Biomarker capability evidence (28)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ABO | Trial sponsor | Named in trial inclusion criteria |
| NAGLU | Trial sponsor | Named in trial inclusion criteria |
| SGSH | Trial collaborator | Named in trial inclusion criteria |
| SGSH | Trial collaborator | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 28 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda recalls, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.