Organization (Industry)
REGENXBIO Inc.
ClinicalTrials.gov lists REGENXBIO Inc. as lead sponsor of 18 trials. It has 11 active development programs.
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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: 0 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 2.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers REGENXBIO Inc.: 18 lead-sponsored trials and 3 legal-entity registrations.
Disease areas (20)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Death | 6 |
| Infant Death | 6 |
| Intellectual Disability | 6 |
| Mucopolysaccharidosis II | 6 |
| Sudden Infant Death | 6 |
Showing 5 of 20 disease areas.
Trials by start year as sponsor or collaborator (10)
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 |
|---|---|
| 2025 | 2 |
| 2024 | 1 |
| 2023 | 2 |
| 2022 | 4 |
| 2021 | 5 |
| 2020 | 3 |
| 2019 | 3 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 1 |
Recruitment duration, a model prediction: 3 trials 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 (11)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Long Term Follow-Up | Intellectual Disability | Not reported | 1 |
| Long Term Follow-Up | Sudden Infant Death | Not reported | 1 |
| Long Term Follow-Up | Mucopolysaccharidosis II | Not reported | 1 |
| Long Term Follow-Up | Infant Death | Not reported | 1 |
| Long Term Follow-Up | Death | Not reported | 1 |
Showing 5 of 11 active programs.
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 |
|---|---|
| 30% hit target (n=10) | 14% on time (n=7) |
Journals published in (2)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Human gene therapy | 1 |
| Lancet (London, England) | 1 |
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 |
|---|---|---|
| 8 | 7 | 2025-07-22 |
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 170,441,000 | -193,878,000 | 228,299,000 |
| 2024 | 83,328,000 | -227,102,000 | 208,522,000 |
| 2023 | 90,242,000 | -263,494,000 | 232,266,000 |
| 2022 | 112,724,000 | -280,321,000 | 242,453,000 |
| 2021 | 470,347,000 | 127,840,000 | 181,437,000 |
| 2020 | 154,567,000 | -111,250,000 | 166,294,000 |
| 2019 | 35,233,000 | -94,733,000 | 124,185,000 |
| 2018 | 218,505,000 | 99,937,000 | 83,873,000 |
| 2017 | 10,393,000 | -73,169,000 | 57,224,000 |
| 2016 | 4,589,000 | -62,967,000 | 45,482,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (29)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-07-20 | Public offering | not disclosed | Sec extracted |
| 2026-07-16 | Public offering | not disclosed | Sec extracted |
| 2026-06-29 | Royalty / licensing | not disclosed | Sec extracted |
| 2026-06-03 | Other financing | not disclosed | Sec extracted |
| 2026-02-12 | Other financing | not disclosed | Edgar offerings |
Showing 5 of 29 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 1 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| REGENXBIO Inc. | Rockville, 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 (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| Government of the United States of America | Co sponsors trial with | 1 |
Latest dated events (63)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-07-20 | Public offering | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-07-16 | Public offering | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-06-29 | Royalty / licensing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-06-03 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-02-12 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
Showing 5 of 63 events.
Biomarker capability evidence (51)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ACD | Trial sponsor | Named in trial inclusion criteria |
| ACD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
| DMD | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 51 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, fda warning letters, fda untitled letters, fda recalls, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.