Bristol Myers Squibb reports Phase 3 trial meets primary endpoint for RYZ101 in rare neuroendocrine tumors
Bristol Myers Squibb’s RayzeBio subsidiary announced that the ACTION‑1 Phase 3 trial of RYZ101 achieved its primary endpoint, showing a statistically significant improvement in progression‑free survival versus standard of care in patients with somatostatin‑receptor‑positive gastro‑enteropancreatic neuroendocrine tumors who had progressed after Lu‑177 therapy. The FDA had granted RYZ101 orphan‑drug designation for this indication in August 2026. The company said it will meet with the FDA to discuss next steps toward a regulatory submission.
Why it matters
The positive topline data could pave the way for an FDA filing, adding a potential new therapy for a rare cancer with limited options. Analysts note that the trial news helped lift BMY shares, which rose 6.5% in pre‑market trading.
Key facts
- 1The ACTION‑1 trial met its primary endpoint with a statistically significant improvement in progression‑free survival. gurufocus.com
- 2The FDA granted RYZ101 orphan‑drug designation for GEP‑NETs in August 2026. gurufocus.com
- 3Bristol Myers Squibb shares rose 6.5% in pre‑market trading after the announcement. finance.yahoo.com
- 4Approximately 18,000 new cases of GEP‑NETs are diagnosed annually in the United States. finance.yahoo.com
- 5Bristol Myers Squibb acquired RayzeBio and RYZ101 in a $4.1 billion takeover. ksl.com
Summary written by AlphAI AI Desk from 11 of 11 sources. Not investment advice. Figures are as stated by the linked sources.