Bristol Myers Squibb Announces Positive Topline Results from the Interim Analysis of Phase 3 ACTION-1 for RYZ101, RayzeBio's Radiopharmaceutical Therapy, in Patients with GEP-NETs (Bristol-Myers Squibb Press Release) - Oct 12, 2026 - "...The ACTION-1 trial (NCT05477576)...met the primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review, and safety results consistent with the known RYZ101 safety profile....The FDA granted RYZ101 Orphan Drug Designation for the treatment of GEP-NETs in August 2026 based on the significant unmet need facing patients with this disease. That designation, combined with the results of this interim analysis, supports RayzeBio's continued development efforts and plans to engage with the FDA to discuss next steps toward a regulatory submission. Detailed results are expected to be presented at a future medical meeting."
FDA filing • Orphan drug • P3 data: top line • Pancreatic Neuroendocrine Tumor
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