Regenxbio reports Q2 2026 results, cites Duchenne trial win and new AbbVie funds

Regenxbio Inc. reported second quarter 2026 financial results on August 6, 2026, along with a series of pipeline updates. Chief Executive Officer Curran Simpson said the Phase III AFFINITY DUCHENNE trial met its primary endpoint, the company dosed the first participant in the NAAVIGATE study in diabetic retinopathy, and the FDA reaffirmed the path forward for RGX-121.¹

On Duchenne muscular dystrophy, the Phase III AFFINITY DUCHENNE trial met its primary endpoint with high statistical significance (p<0.0001), and RGX-202 was well tolerated, with a statistically significant correlation between microdystrophin expression and functional improvement at one year in a subset of nine patients.¹ The confirmatory study of RGX-202 finished enrollment in June 2026 ahead of schedule.¹ Regenxbio remains on track to begin a BLA submission in the third quarter of 2026 under the accelerated approval pathway, with potential approval in the second half of 2027.¹ A new ex-U.S. trial called AFFINITY RISE is expected to start in the first half of 2027 to support global filings.¹

For retinal disease, topline data from the ATMOSPHERE and ASCENT pivotal studies of sura-vec, partnered with AbbVie, are expected in the fourth quarter of 2026, with global regulatory filings anticipated in 2027.¹ The Phase IIb/III NAAVIGATE study for diabetic retinopathy dosed its first patient in June 2026,¹ which triggered a $100 million milestone payment from AbbVie received in July 2026.¹

On RGX-121 for Hunter syndrome, the FDA held a positive Type A meeting with Regenxbio in July 2026 and reaffirmed that no additional studies are required for the BLA resubmission,¹ which the company plans to file in the third quarter of 2026.¹

On finances, cash, cash equivalents and marketable securities totaled $105.5 million as of June 30, 2026, down from $240.9 million at the end of 2025.¹ In July 2026 the company added roughly $100 million from the AbbVie milestone and about $108 million in net proceeds from a stock and warrant offering.¹ Regenxbio said the combined funds are expected to extend its runway into the fourth quarter of 2027.