RayzeBio

What RayzeBio does

RayzeBio is a clinical-stage biopharmaceutical company developing targeted radiopharmaceutical therapies (RPTs) for solid tumor oncology, founded in August 2020 in San Diego, California. The company is built around an Actinium-225 (Ac225) alpha-emitting isotope platform designed to deliver high-energy, short-range alpha particles that cause more double-stranded DNA breaks than conventional beta emitters, a mechanism intended to reduce treatment resistance. The pipeline includes the Phase 3 lead asset RYZ101 (225Ac-DOTATATE) in the ACTION-1 trial for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) progressing after Lu177 therapy, the next-generation SSTR2 agent RYZ401 in Phase 1, the GPC3-targeting theranostic pair RYZ801/RYZ811 in Phase 1/1b for hepatocellular carcinoma, and the ACP3-targeting RYZ701/RYZ711 program for prostate cancer, including PSMA-negative populations. Discovery is anchored by a 28,000 sq ft San Diego research facility, and the company has built a vertically integrated 77,000 sq ft Indianapolis manufacturing facility that combines on-demand Ac225 isotope production with drug product manufacturing, with over $160 million invested and a stated 2-day distribution capability.

RayzeBio is a wholly-owned subsidiary of Bristol Myers Squibb following a $4.1 billion acquisition completed in February 2024, having previously raised approximately $418 million in venture funding across rounds in 2020, 2021, and 2022. The business model is pre-revenue: investigational therapies are currently distributed through clinical trial sites such as Mayo Clinic and approximately 20-30 other U.S. locations, and future commercial sales of approved RPTs will flow through the Indianapolis manufacturing footprint and authorized nuclear medicine treatment centers. As a BMS subsidiary, RayzeBio benefits from parent-company global oncology commercial infrastructure and participates in industry-wide initiatives such as the RLT Angels Association, co-founded in June 2025 with Novartis, GE HealthCare, the European Association of Nuclear Medicine, and the ICPO Foundation to scale radioligand therapy access to 1,000 RLT Centers and one million patients globally.

Name

RayzeBio

Legal name

RayzeBio, Inc.

Website

https://rayzebio.com

Company type

Private

Founded year

2020

Operating status

Acquired

Headcount range

51–100 employees

Short description

RayzeBio is a clinical-stage, Bristol Myers Squibb subsidiary developing Actinium-225 alpha-emitting radiopharmaceutical therapies for solid tumors. Its pipeline includes the Phase 3 lead RYZ101 plus next-generation SSTR2, GPC3, and ACP3 programs, supported by vertically integrated Indianapolis manufacturing and San Diego discovery operations.

Ownership category

akta.pro rank

Product category

Radiopharmaceutical Therapeutics

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414), Irradiation Apparatus Manufacturing (334517)

SIC

Biological Products, (No Disgnostic Substances) (2836), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB)

akta.pro secondary industries

Radiopharmacy Compounding & Dispensing (Hospital/Commercial) (HLAIAGAE), Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC), Radiopharmaceutical CDMO & Manufacturing (GMP Fill-Finish) (HLAIAGAF), Diagnostic Radiopharmaceuticals (SPECT/PET Tracers) (HLAIAGAA), Radiopharmaceutical & Nuclear Medicine Distributors (HLAIAJAI)

Keywords

• Targeted radiopharmaceutical therapy
• Actinium-225 therapeutics
• Oncology drug development
• Radiopharmaceutical manufacturing
• Cancer peptide binders

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Infrastructure, Personnel, Marketing or Sales, Operations

Revenue model

1. Future commercial drug sales (post-approval): RayzeBio is currently clinical-stage and pre-revenue. Future revenue model will rely on commercial sales of approved Actinium-225-based radiopharmaceutical therapies targeting oncology indications, manufactured at the Indianapolis facility at scale of tens of thousands of doses annually.
2. Acquisition value (one-time): RayzeBio was acquired by Bristol Myers Squibb for approximately $4.1 billion (deal closed February 2024 per multiple sources; press release of acquisition was December 2023), generating one-time transaction value rather than ongoing revenue.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

RayzeBio is a clinical-stage biopharmaceutical company developing targeted radiopharmaceutical therapies (RPTs) that deliver the alpha-emitting radioisotope Actinium-225 (Ac225) to solid tumors. Its pipeline includes the lead asset RYZ101 (225Ac-DOTATATE) for SSTR2-expressing tumors, next-generation SSTR2 agent RYZ401, the GPC3-targeting theranostic pair RYZ801/RYZ811 for hepatocellular carcinoma, and the ACP3-targeting theranostic pair RYZ701/RYZ711 for prostate cancer, with discovery and manufacturing vertically integrated across its San Diego research and Indianapolis production sites.

Product overview

RayzeBio is a vertically integrated, clinical-stage radiopharmaceutical therapeutics (RPT) company and a Bristol Myers Squibb subsidiary focused on solid tumor oncology. Its core platform is built around the Actinium-225 (Ac225) alpha-emitting radioisotope, used across multiple programs in a pipeline-plus-modules architecture: the lead asset RYZ101 (SSTR2-targeting 225Ac-DOTATATE) in Phase 3 ACTION-1 for GEP-NETs plus Phase 1b/2 expansion trials for extensive-stage SCLC and HR+/HER2- breast cancer; the next-generation SSTR2 agent RYZ401 (Phase 1); the GPC3-targeting theranostic pair RYZ801 (Ac225 therapeutic) / RYZ811 (Ga68 diagnostic) for hepatocellular carcinoma (Phase 1/1b); the ACP3-targeting theranostic pair RYZ701 (therapeutic) / RYZ711 (diagnostic) for prostate cancer; and pre-clinical programs in ccRCC and additional targets. Discovery is enabled by the San Diego 28,000 sq ft research facility, and commercial-scale supply is anchored by the Indianapolis 77,000 sq ft end-to-end manufacturing facility that combines on-site Ac225 isotope production with drug product manufacturing.

Differentiator

Problem solved

Functional benefit

Products and services

• RYZ101 (225Ac-DOTATATE) Investigational targeted radiopharmaceutical therapy (RPT) composed of DOTATATE bound to Actinium-225, a high-energy alpha-emitting radioisotope, targeting somatostatin receptor type 2 (SSTR2) in GEP-NETs, small cell lung cancer, and HR+/HER2- metastatic breast cancer.
• RYZ401 Next-generation SSTR2-targeting radiopharmaceutical therapy labeled with Actinium-225, designed to offer enhanced tumor retention and decreased kidney uptake versus first-generation SSTR2 agents, with the potential to eliminate the need for co-administration of amino acids.
• RYZ801 / RYZ811 (Theranostic Pair) RYZ801 is a proprietary peptide targeting glypican-3 (GPC3) for delivery of Ac225 to treat hepatocellular carcinoma (HCC); RYZ811 is a paired diagnostic imaging agent using the same peptide binder and chelator with Gallium-68 (Ga68).
• RYZ701 / RYZ711 (ACP3 Program) First-in-class radiopharmaceuticals targeting acid phosphatase 3 (ACP3) for treatment and diagnosis of prostate cancer; RYZ701 is the therapeutic agent and RYZ711 is the diagnostic, targeting ACP3 which is highly expressed in >95% of prostate cancers including PSMA-negative/low tumors, with minimal expression in healthy tissues such as salivary glands and kidneys.

Quantifiable outcome

• RYZ101 Phase 1b ACTION-1 trial enrolled 17 patients all previously treated with Lu177 with disease progression; no dose limiting toxicity observed during the 8-week DLT period in the first treatment cycle; no treatment-related serious adverse events or dose discontinuations.
• +4 more outcomes

Named customers1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Six partnerships are on record, tiered core and flagship.

• Mayo CliniccoreImplementation/ SI/ Consulting Partner · 1 August 2025Mayo Clinic is a key clinical trial site for RayzeBio's RYZ101 actinium-225 alpha-emitting radiopharmaceutical therapy. In August 2025 Mayo Clinic treated the first U.S. patient with RayzeBio's therapy for advanced breast cancer as part of an international Phase 1b/2 trial conducted at Mayo Clinic's three academic sites and approximately 20 other U.S. locations. Mayo Clinic also previously administered RayzeBio's GPC3-targeted radiopharmaceutical theranostic in a first-in-human HCC clinical trial.
• ICPO Foundation (RLT Angels Association co-founders)coreStrategic or Co-development Partner · 20 June 2025RayzeBio (as a Bristol Myers Squibb company) co-founded the RLT Angels Association on June 20, 2025, alongside the European Association of Nuclear Medicine (EANM), GE HealthCare, Novartis, and the ICPO Foundation. The initiative aims to improve access to radioligand imaging and therapies for up to one million patients globally, establish 1,000 RLT Centers worldwide, and develop open-source best practice resources, accreditation standards, and educational tools.
• European Association of Nuclear Medicine (EANM)coreStrategic or Co-development Partner · 20 June 2025Co-founded the RLT Angels Association on June 20, 2025, with RayzeBio, GE HealthCare, Novartis, and ICPO Foundation to expand global access to radiotheranostics, support 1,000 RLT Centers worldwide, and develop best practice resources and accreditation standards.
• GE HealthCarecoreStrategic or Co-development Partner · 20 June 2025Co-founded the RLT Angels Association on June 20, 2025, with RayzeBio, Novartis, EANM, and ICPO Foundation to grow access to radiotheranostics to one million patients globally and establish 1,000 RLT Centers worldwide. GE HealthCare is also a supplier of diagnostic imaging infrastructure complementary to RayzeBio's therapeutic pipeline.
• NovartiscoreStrategic or Co-development Partner · 20 June 2025Co-founded the RLT Angels Association on June 20, 2025, with RayzeBio, EANM, GE HealthCare, and ICPO Foundation. As the only company with currently FDA-approved radioligand therapies (Pluvicto and Lutathera), Novartis's participation signals industry-wide collaboration on access infrastructure for radiotheranostics.
• Bristol Myers SquibbflagshipStrategic or Co-development Partner · 1 February 2024Bristol Myers Squibb acquired RayzeBio for approximately $4.1 billion (deal closed February 2024; acquisition announced December 2023) to enhance BMS's oncology portfolio with RayzeBio's actinium-based radiopharmaceutical therapeutics targeting solid tumors. RayzeBio now operates as a Bristol Myers Squibb subsidiary, leveraging BMS's commercial oncology infrastructure, R&D capabilities, and global manufacturing footprint while retaining its entrepreneurial biotech culture and Indianapolis manufacturing operations.

Scale indicators9 records

Recent moves7 records

Expansion highlights4 records

Others

• GE HealthCare: GE HealthCare supplies diagnostic imaging infrastructure (PET/CT, SPECT) essential to radiopharmaceutical theranostics and is a co-founder of the RLT Angels Association with RayzeBio. Not a direct therapeutic competitor but a critical enabling partner and ecosystem participant.
• Cardinal Health: Cardinal Health operates a major radiopharmaceutical distribution network and is expanding Ac225 production capabilities at its Indianapolis facility to support RayzeBio and other alpha-RPT developers. Adjacent ecosystem participant rather than direct competitor, with strategic supply-side overlap.
• Bristol Myers Squibb: BMS acquired RayzeBio for $4.1B in February 2024, making it the parent company. BMS is also a major oncology player with its own radiopharmaceutical-adjacent portfolio (IO, ADCs) and provides RayzeBio with global commercial, R&D, and manufacturing infrastructure.
• ITM Isotope Technologies: ITM is a leading manufacturer of medical radioisotopes including Lu177 and Ac225, supplying radiopharmaceutical developers globally. While not a direct competitor to RayzeBio's therapeutics, ITM is a critical enabling supplier and potential partner in the same value chain, and competes with RayzeBio's vertically integrated Indianapolis isotope production.

Direct peers

• Telix Pharmaceuticals: Telix develops diagnostic and therapeutic radiopharmaceuticals, with FDA-approved Illuccix (Ga68-PSMA-11) for prostate cancer imaging and an emerging pipeline of alpha-emitting therapeutics. Directly competes with RayzeBio in both diagnostic imaging and the broader theranostic RPT space.
• Lantheus Holdings: Lantheus is a radiopharmaceutical-focused company with a portfolio of diagnostic and therapeutic radiopharmaceuticals, including PSMA-targeted imaging agents and a growing alpha-emitter program (PNT2002/Ac225-PSMA-617 partnership with Point). Directly competes with RayzeBio in the radiopharmaceutical oncology space, particularly in prostate cancer.
• POINT Biopharma (Eli Lilly subsidiary): POINT Biopharma develops radioligand therapies including PNT2002 (Lu177-PSMA-I&T) and an alpha-emitting pipeline, and was acquired by Eli Lilly for $1.4B in 2023. Direct peer to RayzeBio in next-generation radiopharmaceuticals targeting prostate cancer and other solid tumors.

Emerging players

• Fusion Pharmaceuticals: Fusion Pharmaceuticals developed a platform of targeted alpha therapies (TATs) using Ac225 and other alpha-emitting conjugates, with a lead program in solid tumors; acquired by AstraZeneca in 2024. Direct emerging competitor in the Ac225 alpha-RPT space RayzeBio pioneered.

Broad incumbents

• Novartis (Pluvicto / Lutathera): Novartis is the dominant incumbent in radioligand therapy, with FDA-approved Pluvicto (Lu177-PSMA-617) in prostate cancer and Lutathera (Lu177-DOTATATE) in neuroendocrine tumors. Direct competitor to RayzeBio in the same oncology indications (NETs, prostate) using a beta-emitting Lu177 platform rather than RayzeBio's alpha-emitting Ac225 platform.
• Bayer (Xofigo / Algeta heritage): Bayer commercializes Xofigo (Ra223 dichloride), an alpha-emitting radiopharmaceutical for castration-resistant prostate cancer with bone metastases, and has active radioligand programs. Broad incumbent in alpha-emitting RPT and a direct competitor to RayzeBio's prostate cancer programs (RYZ701/RYZ711).

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/rayzebio
• LinkedInlinkedin.com/company/rayzebio

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds4 records

Investors22 records

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M&A

Investments

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Frequently asked questions about RayzeBio