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REGENXBIO plans RGX-202 Duchenne gene therapy BLA submission in Q1 2027, with potential approval in 2H 2027.

05 Nov 2026, 14:05 WIB
PRNewsWire
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Bullish
REGENXBIO plans RGX-202 Duchenne gene therapy BLA submission in Q1 2027, with potential approval in 2H 2027.

REGENXBIO reported Q3 2026 results and confirmed its RGX-202 gene therapy for Duchenne muscular dystrophy is on track for a Biologics License Application (BLA) submission in Q1 2027, aiming for accelerated approval in the second half of 2027. The company also expects topline data from pivotal wet AMD trials in Q4 2026 and continues progress on diabetic retinopathy and other gene therapy programs. Financially, REGENXBIO had $251 million in cash and expects this to fund operations into late Q4 2027. The company recorded a net loss of $40.7 million for Q3 but gained $38 million from a litigation settlement. These developments position REGENXBIO to potentially launch new gene therapies in 2027 and 2028.

REGENXBIO's Q3 2026 financial results and operational highlights provide context for readers following biotech developments. For readers following the health sector, here is Pluang's market snapshot as of Nov 05, 2026 19:01 WIB: out of 150 priced US health stocks tradable on Pluang, 94 rose and 48 fell. Notable movers include ADMA Biologics Inc (ADMA) up 19.56% at USD 12.53 with 100% sell orders, Revolution Medicines Inc. (RVMD) up 7.14% at USD 213.95, and Becton Dickinson and Co (BDX) down 6.86% at USD 194.84 with 100% sell orders. The most notable figure is ADMA's 19.56% gain.

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