| Metric | Value ($ M) | Q1 FY25 |
|---|---|---|
| Revenue | 6.39 | 92.8% |
| Total Income | 6.39 | 92.8% |
| Expenditure | 89.76 | 16.7% |
| PBT | — | |
| Net Profit | -90.05 | 1581.1% |
| OPM | — | |
| NPM | — | |
| EPS | -1.72 | 1533.3% |
REGENXBIO Reports Q1 2026 Financial Results and RGX-202 Topline Data
14 May 2026 · 14 May, 4:51 pm
Summary
REGENXBIO reported financial results for the first quarter ended March 31, 2026. The company announced positive topline results from the pivotal Phase III AFFINITY DUCHENNE® study of RGX-202, with 93% of participants achieving microdystrophin expression above 10%. Revenues for the quarter were $6.4 million, compared to $89.0 million for the same period in 2025, with the decrease primarily attributable to upfront license revenue recognized in the prior year. Net loss for the quarter was $90.1 million, or $1.72 per share. The company expects its cash balance to fund operations into early 2027.
Key Highlights
- 1
REGENXBIO announced positive topline results from the pivotal Phase III AFFINITY DUCHENNE® study of RGX-202.
- 2
93% of participants achieved RGX-202 microdystrophin expression above 10% (p<0.0001) in the AFFINITY DUCHENNE trial.
- 3
A statistically significant correlation was observed between RGX-202 microdystrophin expression level and functional improvement (NSAA, n=9).
- 4
REGENXBIO expects to share topline data with AbbVie from ATMOSPHERE® and ASCENT® pivotal trials of sura-vec using subretinal delivery in Q4 2026.
- 5
Revenues were $6.4 million for the three months ended March 31, 2026, compared to $89.0 million for the three months ended March 31, 2025.
- 6
Net loss was $90.1 million, or $1.72 basic and diluted net loss per share, for the three months ended March 31, 2026.
- 7
REGENXBIO expects its cash, cash equivalents and marketable securities of $150.5 million as of March 31, 2026 to fund its operations into early 2027.
Management Comments
Curran Simpson
REGENXBIO enters a transformative year with positive momentum, reaching significant late-stage milestones to support our potential first- and best-in-class gene therapies. On our mission to bring meaningful new therapies to rare disease communities facing limited options, we remain focused on advancing RGX-202 for Duchenne toward potential BLA submission and are excited to share topline pivotal data in our webcast today; we also continue engaging with the FDA regarding a potential path forward for RGX-121 for Hunter syndrome. In chronic retinal diseases, we are executing against our multi-indication strategy and preparing for the Phase 3 wet AMD readout with partner AbbVie. Additionally, we continue harnessing internal manufacturing capabilities to support anticipated commercial needs. We remain well-positioned to capitalize on several near-term, high-value opportunities and bring these highly differentiated treatments to patients.
Steve Pakola
RGX-202 is the first gene therapy in development for Duchenne to demonstrate strong, statistically significant correlation between microdystrophin expression and functional improvement, a landmark distinction in the field. Today’s topline results underscore how our novel construct and differentiated therapeutic approach support a favorable safety profile and potential clinical benefit, including in older patients where progressive decline is expected. These data support the potential of RGX-202 to become a best-in-class gene therapy for Duchenne patients.
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