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RYZ101 Meets Primary PFS End Point in Phase 3 ACTION-1 Trial for Post–Lutetium-177 GEP-NETs
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Fusion42 · 12 October 2026 · Fusion42 review
The phase 3 ACTION-1 trial of RYZ101, an alpha-emitting targeted radiopharmaceutical, met its primary endpoint showing a significant progression-free survival improvement versus standard care in patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors progressing after lutetium-177 therapy. RayzeBio plans to engage with the FDA for regulatory submission following these positive results.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 12 Oct 2026 and 13 Oct 2026.
◆ ◆ The Wire takeaway
Oncology founders in radiopharmaceuticals must now prepare for rapid engagement with the FDA as RYZ101’s positive phase 3 results open a rare regulatory acceleration opportunity. Your window to position this treatment as the post-lutetium-177 standard is narrowing as competitors will pivot quickly.
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2 sources · first reported 12 Oct 2026 · latest 13 Oct 2026
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