REGENXBIO’s shares fell 4.3% after earnings, with investors likely focused on the company’s dependence on pivotal sura-vec data still expected later this quarter and a potential RGX-202 launch that remains in 2027. The call offered no new efficacy readout or change to those timelines to resolve the clinical and regulatory uncertainty.
- Top-line results from the sura-vec ATMOSPHERE and ASCENT wet AMD trials are expected this quarter; global regulatory submissions are planned for 2027.
- The two pivotal trials have enrolled more than 1,300 patients across 14 countries. Their primary endpoint is non-inferiority in visual acuity at 54 weeks versus anti-VEGF controls.
- REGENXBIO plans to submit the RGX-202 BLA under the accelerated approval pathway in Q1 2027, with potential U.S. approval in the second half of 2027.
- The company remains on track to start the ex-U.S. AFFINITY RISE randomized, placebo-controlled study in the first half of 2027.
- Management said it has trained more than 500 retina specialists and is manufacturing intended commercial supply for RGX-202, but these preparations do not remove the near-term dependence on clinical and regulatory milestones.
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