Regenxbio near pivotal wet AMD gene therapy data, reaffirms Duchenne Q1'27 filing, cash run to Q4'27

 

• Top-line Phase 3 sura-vec wet AMD data from ATMOSPHERE and ASCENT expected by year-end 2026.
• Company reiterates plan to file full RGX-202 Duchenne BLA for accelerated approval in Q1 2027.
• Cash, equivalents, and securities at $251 million; runway extends into late Q4 2027 post key milestones.
• Q3 2026 loss of $0.62 per share on $9.2M revenue, down 69% YoY; beat EPS but missed revenue estimates.
• $100 million AbbVie diabetic retinopathy milestone and $108 million equity raise bolster balance sheet.
• Additional $49 million Sarepta settlement payment in October not included in quarter-end cash figure.
• sura-vec positioned commercially with >500 trained retina surgeons and established subretinal reimbursement infrastructure.
• Key risks: imminent sura-vec pivotal wet AMD data outcome, payer adoption, and FDA acceptance of RGX-202 accelerated approval strategy.
• Mixed quarter, driven by pipeline execution and balance sheet strengthening ahead of multiple binary clinical readouts.

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