REGENXBIO Inc. RGNX
REGENXBIO Inc. (Nasdaq: RGNX) is a rare genetic drug developer. Its lead program, RGX-121 (clemidsogene lanparvovec), is in Phase 3 for Mucopolysaccharidosis type II (MPS II, Hunter syndrome). Its next catalyst on record is sura-vec (ABBV-RGX-314) wet AMD: Topline data from ATMOSPHERE and ASCENT pivotal trials (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: sura-vec (ABBV-RGX-314) wet AMD — Topline data from ATMOSPHERE and ASCENT pivotal trials (Q4 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| RGX-121 (clemidsogene lanparvovec) | MPS II | gene therapy | Phase 3 |
| RGX-202 | Duchenne muscular dystrophy | gene therapy | Phase 3 |
| sura-vec (ABBV-RGX-314), subretinal ATMOSPHERE/ASCENT | wet age-related macular degeneration | gene therapy | Phase 3 |
| sura-vec NAAVIGATE (Phase IIb/III) | diabetic retinopathy | gene therapy | Phase 2 |
| sura-vec AAVIATE / ALTITUDE (suprachoroidal) | wet AMD / diabetic retinopathy, DME | gene therapy | Phase 2 |
| RGX-111 | MPS I (Hurler syndrome) | gene therapy | Phase 1 |
Recent results and decisions
- Aug 6, 2026completed enrollment Confirmatory RGX-202 trial completed enrollment in June 2026, ahead of schedule.
The confirmatory study of RGX-202 completed enrollment in June 2026 ahead of schedule due to strong patient demand and robust investigator interest.
Filing - Jun 29, 2026started First patient dosed in the Phase IIb/III NAAVIGATE trial of sura-vec in diabetic retinopathy, triggering a $100 million AbbVie milestone.
today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery.
Filing - May 14, 2026met Pivotal Phase III AFFINITY DUCHENNE met primary endpoint: 93% reached >10% microdystrophin at Week 12 (n=30, p<0.0001); mean expression 71.1%; well tolerated, 2 SAEs.
The trial met its primary endpoint with high statistical significance (p<0.0001), with 93% of participants reaching at least 10% microdystrophin expression at Week 12 (n=30).
Filing
7 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.