REGENXBIO reports Q3 2026 results, confirms Duchenne BLA and wet AMD data timelines
The company said it remains on track for a Q1 2027 RGX-202 BLA submission and expects topline sura-vec wet AMD data in Q4 2026, while cash stood at $251.0 million.
REGENXBIO Inc. reported financial results for the quarter ended September 30, 2026 on November 5, 2026. The company expects to hold a pre-BLA meeting with the FDA in the fourth quarter of 2026 and remains on track to submit a Biologics License Application for RGX-202, its gene therapy for Duchenne muscular dystrophy, in the first quarter of 2027 under the accelerated approval pathway, which could support approval in the second half of 2027.1 REGENXBIO also plans to start "AFFINITY RISE," a placebo-controlled study outside the United States meant to support global regulatory filings for RGX-202, in the first half of 2027.1
In retinal disease, REGENXBIO said it expects to report topline results with AbbVie from the ATMOSPHERE and ASCENT pivotal trials of sura-vec given by subretinal delivery in the fourth quarter of 2026.1 Global regulatory submissions for that program are expected in 2027.1 Separately, the Phase IIb/III NAAVIGATE study of suprachoroidal sura-vec in patients with non-proliferative diabetic retinopathy without center-involved diabetic macular edema is enrolling.1
In neurodegenerative disease, the FDA placed a clinical hold on RGX-121 in August 2026 after asymptomatic spine MRI findings turned up in five participants in the CAMPSIITE study.1 REGENXBIO said it continues to collect and evaluate additional imaging and follow-up data.1
On finances, cash, cash equivalents and marketable securities totaled $251.0 million as of September 30, 2026, up from $240.9 million at the end of 2025.1 The increase mainly reflected a $100.0 million milestone payment from AbbVie tied to the first NAAVIGATE patient dosed, plus $107.8 million in net proceeds from a July 2026 stock and pre-funded warrant offering, partly offset by operating cash use.1 That total excludes a separate $39.0 million payment received in October 2026 under a settlement with Sarepta Therapeutics.1 REGENXBIO said the September 30 cash balance, combined with the October settlement proceeds, is expected to fund operations into late fourth quarter 2027.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.