Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) on Monday announced positive topline results from the planned interim analysis of the Phase 3 ACTION-1 trial evaluating RYZ101, a radiopharmaceutical therapy developed by its subsidiary RayzeBio, in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival, as assessed by blinded independent central review, with safety results consistent with the therapy's established profile.

The trial compares RYZ101 with investigator-selected standard-of-care treatments in patients whose disease progressed following lutetium-177-based therapy. The US Food and Drug Administration (FDA) granted RYZ101 Orphan Drug Designation for GEP-NETs in August 2026, reflecting the significant unmet medical need in this patient population.

RayzeBio plans to engage with the FDA to discuss next steps toward a regulatory submission, with detailed trial results expected at a future medical meeting. Enrolled participants will continue receiving care under the study protocol and will be followed for overall survival.