COMPANY
REGENXBIO Inc.
Since the raise (Jul 17, 2026): 11 of 11 open jobs were first seen after it.
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| VP, Global Rare Disease Franchise | Remote | Oct 1, 2026 | Oct 8, 2026 |
| Vice President, Information Technology | Rockville, Maryland | Oct 1, 2026 | Oct 8, 2026 |
| People Intern | Rockville, Maryland | Sep 30, 2026 | Oct 8, 2026 |
| Associate Director, Regulatory Affairs | Rockville, Maryland | Sep 29, 2026 | Oct 8, 2026 |
| Head of Sales, Rare Disease | Remote | Sep 29, 2026 | Oct 8, 2026 |
Trial and FDA signals
- FDA complete response letter Received an FDA complete response letter (BL 125840, letter dated Feb 7, 2026); 12 roles open. FDA BL 125840 (Feb 7, 2026)
Evidence (1 event)
- Feb 7, 2026 · FDA BL 125840
CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE February 7, 2026 REGENXBIO, Inc. Attention: Steve Pakola, MD Rockville, MD (street omitted) Dear Dr. Pakola: Please refer to your Biologics License Application (1b) (4
- Feb 7, 2026 · FDA BL 125840
Timeline
- Board tracked Radar started tracking this company’s job board (11 open jobs at last check). source ↗
- Raise Follow-on offering: $100M (total, as published), announced Jul 17, 2026. Source: SEC filing. source ↗
- Trial start Phase 3: RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome) source ↗
- Debt Debt financing: $250M (up to, as announced), announced May 19, 2025. Source: SEC filing. source ↗
- Partnership Partnership / licensing announced Mar 4, 2025. Source: SEC filing. source ↗
- Partnership Partnership / licensing: $110M (upfront, as published); deal value up to $700M (kept separate from upfront), announced Jan 14, 2025. Source: SEC filing. source ↗
- Trial start —: Long Term Follow-up for RGX-202 source ↗
- Trial start —: Long Term Follow-Up for RGX-111 source ↗
- Trial start Phase 2/Phase 3: AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD) source ↗
- Trial start —: AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD source ↗
- Trial start —: Mucopolysaccharidosis Type II Observational source ↗
- Trial start —: An Observational Study in Children With CLN2 Batten Disease source ↗
- Trial start —: A Retrospective, Natural History Study in Children With CLN2 source ↗
- Trial start —: Long-term Follow-Up for RGX-121 source ↗
- Trial start Phase 1/Phase 2: RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome) source ↗
- Trial start —: Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients source ↗
- Trial start —: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501 source ↗
- Trial start Phase 1/Phase 2: RGX-111 Gene Therapy in Patients With MPS I source ↗
- Trial start Phase 2/Phase 3: CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome) source ↗
- Trial start —: Mucopolysaccharidosis Type II Natural History source ↗
- Trial start Phase 1/Phase 2: Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial source ↗
- Trial start Phase 1/Phase 2: A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH) source ↗
Upcoming milestones
- 2027-09 (ESTIMATED) · · Long Term Follow-Up for RGX-111 · NCT06103487
- Apr 30, 2028 (ESTIMATED) · Phase 3 · RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome) · NCT07236606
- 2028-10 (ESTIMATED) · · Long-term Follow-Up for RGX-121 · NCT04597385
- Dec 1, 2029 (ESTIMATED) · · Long Term Follow-up for RGX-202 · NCT06491927
Open jobs 11
| Title | Location (from posting, not HQ) | Employer posted | First seen | Level |
|---|---|---|---|---|
| VP, Global Rare Disease Franchise | Remote | Oct 1, 2026 | Oct 8, 2026 | Executive |
| Vice President, Information Technology | Rockville, Maryland | Oct 1, 2026 | Oct 8, 2026 | Executive |
| People Intern | Rockville, Maryland | Sep 30, 2026 | Oct 8, 2026 | Entry |
| Associate Director, Regulatory Affairs | Rockville, Maryland | Sep 29, 2026 | Oct 8, 2026 | Senior |
| Head of Sales, Rare Disease | Remote | Sep 29, 2026 | Oct 8, 2026 | Executive |
| Associate Director, People Business Partner | Rockville, Maryland | Sep 14, 2026 | Oct 8, 2026 | Senior |
| Director, Commercial Data, Advanced Analytics & Forecasting | Remote | Sep 11, 2026 | Oct 8, 2026 | Senior |
| Market Development Director - Southeast Region | Remote | Sep 4, 2026 | Oct 8, 2026 | Senior |
| Associate Director, Rare Disease Product Marketing | Rockville, Maryland | Aug 14, 2026 | Oct 8, 2026 | Senior |
| Senior Director, Global Program Development Lead - DMD/Neuromuscular | Rockville, Maryland | Jan 30, 2026 | Oct 8, 2026 | Senior |
| Senior Director/Director, Medical Science Liaisons (Neuromuscular/DMD) | Remote | Nov 6, 2025 | Oct 8, 2026 | Senior |
Funding
- Follow-on offering: $100M (total, as published), announced Jul 17, 2026. Source: SEC filing. source ↗
- Debt financing: $250M (up to, as announced), announced May 19, 2025. Source: SEC filing. source ↗
- Partnership / licensing announced Mar 4, 2025. Source: SEC filing. source ↗
- Partnership / licensing: $110M (upfront, as published); deal value up to $700M (kept separate from upfront), announced Jan 14, 2025. Source: SEC filing. source ↗
Clinical trials (lead sponsor) 18
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04597385 | Long-term Follow-Up for RGX-121 | Not listed | Active, not recruiting | Mar 14, 2021 | 2028-10 (estimated) |
| NCT05693142 | AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD) | Phase 2/Phase 3 | Active, not recruiting | Jan 4, 2023 | 2026-09 (estimated) |
| NCT05683379 | AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Males With DMD | Not listed | Active, not recruiting | Dec 20, 2022 | Jun 30, 2026 (actual) |
| NCT07652606 | Expanded Access to RGX-202 | Not listed | Temporarily not available | Not listed | Not listed |
| NCT07236606 | RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome) | Phase 3 | Active, not recruiting | Nov 25, 2025 | Apr 30, 2028 (estimated) |
| NCT06103487 | Long Term Follow-Up for RGX-111 | Not listed | Enrolling by invitation | Jul 24, 2023 | 2027-09 (estimated) |
| NCT06491927 | Long Term Follow-up for RGX-202 | Not listed | Enrolling by invitation | May 8, 2024 | Dec 1, 2029 (estimated) |
| NCT03580083 | RGX-111 Gene Therapy in Patients With MPS I | Phase 1/Phase 2 | Suspended | Apr 3, 2019 | Jul 7, 2027 (estimated) |
| NCT04571970 | RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome) | Phase 1/Phase 2 | Completed | Mar 11, 2021 | May 9, 2023 (actual) |
| NCT03566043 | CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome) | Phase 2/Phase 3 | Active, not recruiting | Sep 27, 2018 | Nov 27, 2023 (actual) |
| NCT02651675 | A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH) | Phase 1/Phase 2 | Terminated | 2016-03 | Nov 27, 2020 (actual) |
| NCT03066258 | Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial | Phase 1/Phase 2 | Completed | Mar 29, 2017 | Nov 24, 2019 (actual) |
| NCT04080050 | A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501 | Not listed | Unknown status (ClinicalTrials.gov) | Sep 30, 2019 | Sep 29, 2024 (estimated) |
| NCT04591834 | Mucopolysaccharidosis Type II Observational | Not listed | Withdrawn | 2022-03 | 2025-07 (estimated) |
| NCT03529786 | Mucopolysaccharidosis Type II Natural History | Not listed | Completed | Sep 27, 2017 | Mar 22, 2022 (actual) |
| NCT04462692 | An Observational Study in Children With CLN2 Batten Disease | Not listed | Withdrawn | Mar 31, 2021 | 2023-10 (estimated) |
| NCT04480476 | A Retrospective, Natural History Study in Children With CLN2 | Not listed | Withdrawn | Mar 31, 2021 | 2022-04 (estimated) |
| NCT04148001 | Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients | Not listed | Completed | Dec 4, 2019 | Apr 8, 2020 (actual) |
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