Asset profile

RYZ101 · Bristol-Myers Squibb (BMY)

Indication: somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) after Lu177-based therapy
Also known as: 225Ac-DOTATATE, 225Ac-DOTATATE

Company

Bristol Myers Squibb discovers, develops, and markets drugs for various therapeutic areas, such as cardiovascular, cancer, and immune disorders. A key focus for Bristol is immuno-oncology, where the firm is a leader in drug development. Bristol derives close t…

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On the calendar

Dec 2026

~ Dec 2026

BMYBristol-Myers Squibb

RYZ101: Phase 3 trial NCT05477576 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Dec 2026

Dec 31, 2026

in 69 days

BMYBristol-Myers Squibb

RYZ101: Phase 1/Phase 2 trial NCT07150806 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

Oct 2028

~ Oct 2028

BMYBristol-Myers Squibb

RYZ101: Phase 1/Phase 2 trial NCT06590857 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Timeline

Newest first.

Oct 12, 2026

10:55 AM

BMYBristol-Myers Squibb

BMY Announces Positive Phase 3 ACTION-1 Topline for RYZ101 in GEP-NETs

Topline resultsCompany press release Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 12, 2026

Primary endpoint metFavourable

BMY Announces Positive Phase 3 ACTION-1 Topline for RYZ101 in GEP-NETs

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

58 of 86 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

RayzeBio Not US-listedPartner

BMYBristol-Myers SquibbOwner

Company press release Oct 12, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT06590857	Phase 1/2	Recruiting	Oct 1, 2028	64	25 of 31 sites in the United States
NCT07150806	Phase 1/2	Recruiting	Dec 31, 2026	30	1 of 1 sites in the United States
NCT05477576	Phase 3	Active, not recruiting	Dec 1, 2026	343	32 of 54 sites in the United States

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