What Nucleus RadioPharma does

Nucleus RadioPharma is a privately held, venture-backed contract development and manufacturing organization (CDMO) focused exclusively on radiopharmaceuticals for targeted radiotherapy and theranostic oncology applications. Founded in October 2022 by Eclipse Ventures and Mayo Clinic and headquartered in Rochester, Minnesota, the company was created to remove the manufacturing, supply-chain, and delivery bottlenecks that limit patient access to short half-life radiopharmaceuticals. Its customers are pharmaceutical and biotech companies developing targeted radiotherapies and theranostics; the company explicitly positions as a "collaborator, not competitor" by holding no internal drug development program that could conflict with client engagements.

The platform is an isotope-flexible, end-to-end radiopharmaceutical CDMO spanning four operational modules: LABS (R&D, including chelation, radiolabeling, analytical method development, formulation, and stability planning), Supply Chain (specialty logistics with proprietary IATA 7A/Type A shipping packages and a real-time GPS-tracking mobile app), Manufacturing (clinical through commercial dose manufacturing and fill/finish), and Quality & Regulatory (electronic QMS aligned to 21 CFR 211 and ICH Q10, plus NRC, DOT, ATF, and HAZMAT licensing). Nucleus is licensed to handle an unusually broad isotope portfolio including Lu-177, Ac-225, Cu-61/64/67, Pb-212, Tb-149/152/155/161, Y-90, I-131, and others. Production is anchored at a Rochester, MN facility (~10K starting capacity scaling to ~50K vials/year) with a 47,000+ sq ft Springhouse Innovation Park, PA expansion site under construction (planned 2028, ~450K vials/year, aligned with EU Annex 1 and ISO 13408-6). A flagship commercial manufacturing agreement with Clarity Pharmaceuticals reserves 50,000 doses/year in Rochester and 600,000 doses/year in Springhouse for Cu-64 SAR-bisPSMA, contingent on FDA NDA approval.

The company is also extending beyond pure CDMO services into delivery hardware via a first-of-its-kind shielded theranostic infusion system for Lu-177 and Ac-225 (regulatory submission targeted Fall 2025, commercial launch 2026). Nucleus has raised approximately $106M across seed (2022), Series A (2023, co-led by Eclipse and GE Healthcare with Mayo Clinic, Fox Chase, Mercy Health, University of Missouri, Echo Global Logistics, and Granger), an AstraZeneca-led Series A extension (2024), and a $50M OrbiMed financing (April 2026). The board and leadership combine a former FDA Commissioner (CEO Stephen Hahn), Mayo Clinic's former Chair of Nuclear Medicine (CSO/Geoffrey Johnson), and senior operations executives drawn from Genentech/Roche, Foundation Medicine, Eli Lilly, and AstraZeneca. AstraZeneca holds a board seat.

Name

Nucleus RadioPharma

Legal name

Nucleus RadioPharma

Website

https://nucleusrad.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

51–100 employees

Short description

Nucleus RadioPharma is a radiopharmaceutical CDMO serving pharma and biotech developers of targeted radiotherapies and theranostics, offering isotope-flexible end-to-end development, manufacturing, logistics, and regulatory services from facilities in Rochester, MN and Springhouse, PA.

Ownership category

akta.pro rank

Product category

Radiopharmaceutical Contract Manufacturing (CDMO)

NAICS

Pharmaceutical and Medicine Manufacturing (3254)

akta.pro primary industry

Radiopharmaceutical CDMO & Manufacturing (GMP Fill-Finish) (HLAIAGAF)

akta.pro secondary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

Keywords

• Radiopharmaceutical manufacturing
• Contract development services
• Radiolabeling development
• Isotope supply logistics
• Theranostic CDMO

Headquarters

HQ city

Rochester

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Development & Manufacturing (CDMO) services: End-to-end CDMO revenue stream covering radiolabeling development, chelation, analytical method development, Phase 0–III clinical manufacturing, technology transfer, and commercial dose manufacturing (fill/finish). Customers pay for project-based and ongoing manufacturing capacity at Rochester, MN (10K–50K doses/year) and Springhouse, PA (~450K doses/year at full capacity).
2. Isotope supply and specialty radiopharmaceutical logistics: Revenue stream from isotope sourcing agreements with alpha and beta emitter suppliers plus specialty logistics (custom IATA 7A/Type A packages with proprietary real-time GPS tracking app). Provides isotope supply redundancy and just-in-time distribution to hospitals and destination medical centers.
3. Quality, regulatory and compliance services: Regulatory and quality support aligned with cGMP expectations including FDA, NRC and USDOT requirements, supported by electronic QMS across the product lifecycle. Bundled within CDMO engagements.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels3 records

Core offering

Nucleus RadioPharma is an end-to-end contract development and manufacturing organization (CDMO) partner dedicated to building clinical and commercial supply chains for targeted radiotherapies and theranostics. The company provides flexible radiopharmaceutical CDMO services across the lifecycle—from early development and pre-clinical research through Phase 0–III clinical manufacturing and commercialization—via an operational Rochester, MN facility and a planned Springhouse, PA expansion site. It operates as a non-competing collaborator (no internal drug development), with an unusually broad, isotope-flexible manufacturing platform, proprietary GPS-tracked specialty logistics, and is also developing a first-of-its-kind shielded theranostic infusion system.

Product overview

Nucleus RadioPharma offers a unified full-service radiopharmaceutical CDMO platform, organized around four core service modules—LABS (R&D), Supply Chain, Manufacturing, and Quality & Regulatory—that together support clients from early development through commercialization. These capabilities are delivered through two facility footprints: an operational Rochester, MN site (10K starting capacity scaling to ~50K doses/year) and a planned Springhouse Innovation Park, PA expansion site (~450K doses/year). Industry-specific Pharma and Bio Tech solutions tailor the offering to client segments, and the company is also developing the Theranostic Shielded Infusion System—a first-of-its-kind shielded infusion device for Lu-177 and Ac-225 therapies—to address workflow gaps in radiopharmaceutical delivery.

Differentiator

Problem solved

Functional benefit

Products and services

• Full-Service Radiopharmaceutical CDMO
• Theranostic Shielded Infusion System

Quantifiable outcome

• Rochester facility starting capacity 10K product vials/year, scaling to 40-50K/year; Springhouse PA facility ~450K vials/year at full capacity
• +4 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered flagship, core and minor.

• Thermo Fisher ScientificflagshipStrategic or Co-development Partner · 15 June 2026Nucleus RadioPharma announced a Strategic Alliance with Thermo Fisher Scientific to advance radiopharmaceutical development and clinical execution.
• BWXT MedicalcoreStrategic or Co-development Partner · 5 June 2026Nucleus RadioPharma and BWXT Medical entered a Master Purchase and Supply Agreement for critical radiopharmaceutical isotopes, securing isotope supply redundancy for Nucleus's manufacturing operations.
• Clarity PharmaceuticalsflagshipStrategic or Co-development Partner · 14 April 2026Clarity Pharmaceuticals signed a Commercial Manufacturing Agreement with Nucleus RadioPharma for the production of 64Cu-SAR-bisPSMA, a next-generation diagnostic imaging agent for prostate cancer detection. Covers Rochester, MN facility (50,000 doses/year) and planned Springhouse, PA facility (600,000 doses/year opening 2028), enabling nationwide US distribution and expansion to select international markets including Europe, pending Phase III AMPLIFY/CLARIFY trial success and FDA NDA approval.
• SHINE TechnologiescoreTechnology or Integration · 1 January 2024SHINE Technologies is collaborating with Blue Earth Therapeutics and Nucleus RadioPharma on Lutetium-177 supply for targeted cancer treatments (referenced in Lutetium-177 industry research).
• Mayo ClinicflagshipStrategic or Co-development Partner · 12 October 2022Mayo Clinic co-created and provided seed funding for Nucleus RadioPharma to develop radiopharmaceuticals for cancer treatment. Mayo Clinic's former Chair of Nuclear Medicine, Dr. Geoffrey Johnson, is co-founder and CSO; Manu Nair (Associate Chief Business Development Officer at Mayo Clinic) serves on Nucleus's Board of Directors.
• Kite Pharma, a Gilead CompanyminorOthersChris McDonald, Global Head of Technical Operations at Kite Pharma (Gilead), serves on Nucleus RadioPharma's Board of Directors. Relationship is primarily board-level executive overlap rather than an operational commercial partnership.
• Harbinger HealthminorOthersStephen Hahn, former CEO of Harbinger Health, now serves as CEO and Board Member at Nucleus RadioPharma. Relationship is executive-level rather than commercial.

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Emerging players

• Abdera Therapeutics: Early-stage radiopharmaceutical biotech developing targeted alpha and beta therapies; representative of the biotech customer segment Nucleus targets with its Bio Tech CDMO solutions.
• Telix Pharmaceuticals: Developer of diagnostic and therapeutic radiopharmaceuticals (e.g., Illuccix) with growing in-house manufacturing and external CDMO relationships; a peer on the demand side for radiopharma CDMO capacity and a possible direct competitor for theranostic manufacturing.
• BWXT Medical: Supplies medical isotopes and is a Nucleus supply partner; comparable as a vertically integrated radiopharma manufacturer, though more focused on isotope production than finished-dose CDMO services.
• RayzeBio (a Bristol Myers Squibb company): Actinium-225-focused radiopharma developer acquired by BMS for $4.1B; a peer on the demand side for Ac-225 manufacturing capacity and a potential long-term CDMO customer of Nucleus's platform.

Broad incumbents

• PETNET Solutions (Siemens Healthineers): One of the largest PET and SPECT radiopharmaceutical manufacturing and distribution networks in the U.S. and globally; competes directly with Nucleus for pharma/biotech CDMO contracts and offers a broad portfolio rather than a single-isotope specialty.
• Lantheus Holdings: Vertically integrated radiopharmaceutical company with both proprietary products (e.g., Pylarify, Definity) and established manufacturing/distribution infrastructure; competes with Nucleus both for CDMO clients and for downstream hospital contracts.
• Cardinal Health (Nuclear & Precision Health Solutions): Operates one of the largest U.S. radiopharma distribution and manufacturing networks through its Nuclear & Precision Health Solutions unit; competes with Nucleus on commercial fill/finish and distribution for radiopharmaceuticals.
• GE HealthCare (Pharmaceutical Diagnostics): Manufactures and distributes PET tracers and radiopharmaceuticals globally and is a Nucleus investor/board-affiliated partner; a broad incumbent that both overlaps with and accelerates Nucleus's reach.

Direct peers

• Curium Pharma: Global nuclear medicine CDMO operating large-scale PET, SPECT, and therapeutic radiopharmaceutical manufacturing; a directly comparable radiopharma CDMO peer with broad isotope capability similar to Nucleus's platform.
• IBA RadioPharma Solutions: Belgian provider of radiopharma production solutions, including cyclotrons, hot cells, and contract manufacturing; a directly comparable equipment-and-services CDMO peer serving radiopharma developers globally.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/nucleusrad
• LinkedInlinkedin.com/company/nucleus-radiopharma

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds4 records

Investors10 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nucleus RadioPharma