Bel-sar (AU-011) - (CoMpass)

June 1, 2026: Aura Biosciences, Inc. (NASDAQ: AURA) announced it has completed enrollment of 108 patients in its registration-enabling, global randomized Phase 3 CoMpass trial evaluating belzupacap sarotalocan (bel-sar; AU-011) as a frontline treatment for early choroidal melanoma. The study compares bel-sar versus sham control and is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA. Aura expects topline data from the 15-month primary endpoint in the second half of 2027, positioning this readout as the next major catalyst for the program. The company also noted prior regulatory designations for bel-sar in early choroidal melanoma, including Orphan Drug Designation from both the FDA and EMA and Fast Track designation from the FDA.