SOFIE

What SOFIE does

SOFIE is a privately held radiopharmaceutical company operating a vertically integrated platform for PET diagnostics and theranostics manufacturing, headquartered in Dulles, Virginia and founded in 2008. The company runs 15 U.S. manufacturing and radiopharmacy locations — including sites in Totowa NJ, Gilroy CA, Romeoville IL, Cleveland OH, Sanford FL, Kansas City MO, Houston TX, and Decatur IL — producing over 567,000 doses annually through 14+ network sites committed to on-time delivery. Its proprietary core asset is [18F]FAPI-74, a fluorine-18 radiolabeled PET tracer targeting Fibroblast Activation Protein (FAP), licensed from Heidelberg University Hospital and now advancing through two Phase 3 clinical programs: FAPI-GO for gastroesophageal cancers and FAPI-PRO for pancreatic ductal adenocarcinoma.

The company generates revenue across three streams: (1) direct manufacturing and distribution of PET radiopharmaceuticals (including common tracers and proprietary FAPI products) to hospitals, imaging centers, and healthcare systems via its radiopharmacy network; (2) contract manufacturing / CDMO services to pharmaceutical and academic clients, channeled through its Theranostics Center of Excellence for clinical trial material and commercial supply; and (3) supply and licensing arrangements for FAPI-based diagnostic and companion-diagnostic agents, including an agreement to supply [18F]FAPI-74 to Eli Lilly's FiREBOLT FAP Radioligand Therapy study. Pricing is quote-based and not publicly disclosed. Go-to-market is enterprise-direct and sales-led, targeting pharmaceutical companies, healthcare systems, and academic medical centers.

Distribution is handled through the company's owned radiopharmacy network, with extended product shelf-life (12 hours post-End of Synthesis) and an 8-hour delivery radius from activated sites enabling broad domestic coverage. Marketing and education outreach is conducted through scientific conferences (SNMMI, EANM, ASCO GI), peer-reviewed publications, webinars, a quarterly "Focus on FAPI" newsletter, and an educational hub aimed at PET imaging practitioners. The leadership team is led by Patrick Phelps (President and CEO), with Sherly Mosessian, PhD as Chief Scientific Officer; ownership includes a 2024 growth investment from Trilantic North America.

Name

SOFIE

Legal name

SOFIE Co.

Website

https://sofie.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

251–500 employees

Short description

SOFIE is a privately held radiopharmaceutical company operating 15 U.S. manufacturing and radiopharmacy sites that produce over 567,000 PET doses annually and supply its lead FAPI-based diagnostic tracer [18F]FAPI-74 — currently in two Phase 3 oncology trials — to hospitals, imaging centers, pharmaceutical companies, and academic institutions.

Ownership category

akta.pro rank

Product category

Radiopharmaceutical Manufacturing and Distribution

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Health Services (8000), Surgical & Medical Instruments & Apparatus (3841), Services-Misc Health & Allied Services, Nec (8090)

akta.pro primary industry

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC)

akta.pro secondary industries

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• PET radiopharmaceutical manufacturing
• Molecular imaging diagnostics
• Radiopharmacy network services
• Radiopharmaceutical contract manufacturing
• Theranostic cancer imaging

Headquarters

HQ city

Culver City

HQ country

United States

HQ region

North America

Offices9 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Radiopharmaceutical Manufacturing and Distribution: Manufacturing and distribution of PET radiopharmaceuticals through company-owned radiopharmacy network. Produces over 567,000 doses annually across 15 U.S. locations for diagnostic imaging services.
2. Contract Manufacturing (CDMO Services): Provides contract manufacturing services to pharmaceutical companies and academic institutions through its network and Theranostics Center of Excellence for clinical needs.
3. FAPI Clinical Trial Support: Supply of [18F]FAPI-74 for pharmaceutical collaborations including Lilly's FiREBOLT FAP Radioligand Therapy study and academic investigator-initiated studies.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

SOFIE is a radiopharmaceutical company that manufactures and distributes PET (positron emission tomography) radiopharmaceuticals through its network of radiopharmacies across the United States. It operates a vertically integrated business spanning proprietary diagnostic tracer development (lead asset [18F]FAPI-74 targeting Fibroblast Activation Protein for GI cancers), GMP-compliant contract development and manufacturing (CDMO) services for clinical and commercial supply, and a Theranostics Center of Excellence serving pharmaceutical, academic, and healthcare provider customers.

Product overview

SOFIE is a radiopharmaceutical company offering a portfolio of diagnostic PET tracers and contract manufacturing services. The core product is [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP) for cancer imaging. The company operates a network of 14+ radiopharmacies producing over 567,000 doses annually, provides CDMO contract manufacturing services, and has a Theranostics Center of Excellence. SOFIE also runs clinical development programs including Phase 3 trials (FAPI-GO for gastroesophageal cancers and FAPI-PRO for pancreatic cancer), an educational hub for PET imaging, and a FAPI Outreach Program for research collaboration.

Differentiator

Problem solved

Functional benefit

Products and services

• [18F]FAPI-74 PET Tracer

Quantifiable outcome

• 100% positive predictive value in detecting FAP-expressing cells
• +3 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core and minor.

• RadNetcoreStrategic or Co-development PartnerClinical trial partnership for Phase 3 FAPI-GO study. RadNet provides imaging capabilities through its national network of 407 outpatient imaging centers. RadNet's Director of PET/CT and Research, Judith Rose MD, serves as principal investigator.
• Helios Clinical ResearchcoreStrategic or Co-development PartnerClinical trial network dedicated to accelerating access to innovative therapies through high-quality, patient-centered research. In partnership with The Oncology Institute of Hope and Innovation, Helios embeds clinical trials into real-world care settings.
• The Oncology Institute of Hope and InnovationminorStrategic or Co-development PartnerNationally recognized leader in community-based oncology care collaborating with Helios Clinical to expand access to cutting-edge cancer clinical trials.
• Heidelberg University Hospital (UKHD)coreTechnology or IntegrationLicensor of FAPI (quinoline-based PET tracers acting as FAP inhibitors) technology developed by the team at Heidelberg University Hospital. SOFIE holds license for FAPI development and commercialization.
• Eli Lilly and CompanycoreStrategic or Co-development PartnerSOFIE is a supplier of [18F]FAPI-74 for Lilly's FiREBOLT FAP Radioligand Therapy study (NCT07213791), supporting pharmaceutical collaboration in radiotheranostics.

Scale indicators8 records

Recent moves9 records

Expansion highlights7 records

Broad incumbents

• Bracco Imaging: Bracco is a global imaging agent company with a portfolio spanning contrast media and radiopharmaceuticals, providing a broader-market analog to SOFIE's diagnostic imaging focus with global distribution reach SOFIE lacks.
• GE HealthCare (Radiopharma): GE HealthCare operates a global radiopharmacy and PET tracer manufacturing footprint as part of its broader imaging and diagnostics portfolio, overlapping with SOFIE on commercial distribution but with materially greater scale and capital resources.
• Novartis (Pluvicto / radioligand therapy franchise): Novartis pioneered commercial radioligand therapy with Pluvicto/Lutathera, establishing the theranostic Dx/Tx paradigm that SOFIE is building toward with FAPI-74 and its Lilly-supplied FAP therapy program.

Direct peers

• Telix Pharmaceuticals: Telix develops and commercializes radiopharmaceuticals for cancer imaging and therapy, including PSMA-targeted agents; its companion-diagnostic-plus-therapy model parallels SOFIE's FAPI-74 / Lilly FiREBOLT theranostic positioning.
• Curium Pharma: Curium is a global radiopharmaceutical company manufacturing and distributing PET and SPECT tracers, with vertical integration across manufacturing, distribution, and contract services — a near-identical operating model to SOFIE.
• PETNET Solutions (Siemens Healthineers): PETNET Solutions operates a national U.S. radiopharmacy network producing and distributing PET radiopharmaceuticals for hospitals and imaging centers, making it the most direct operational peer to SOFIE's 15-site distribution business.
• Cardinal Health Nuclear & Precision Health Solutions: Cardinal Health operates a large U.S. nuclear pharmacy and radiopharmaceutical distribution network serving hospitals and imaging centers, directly competing with SOFIE's commercial dose distribution franchise.
• Lantheus Holdings: Lantheus is a radiopharmaceutical-focused company with proprietary diagnostic agents (e.g., PYLARIFY) and CDMO services, comparable to SOFIE's combined FAPI-74 pipeline plus commercial distribution and contract manufacturing business.

Emerging players

• Blue Earth Diagnostics: Blue Earth Diagnostics develops and commercializes PET radiopharmaceuticals for cancer imaging, sharing SOFIE's diagnostic oncology focus with a more limited pipeline and narrower indication footprint.

Regional players

• Jubilant Pharmova (Jubilant Biosys / Radiopharma): Jubilant is an existing SOFIE investor (lead in the 2020 round) and operates radiopharmaceutical and contract manufacturing businesses primarily outside the U.S., making it a comparable CDMO/radiopharma peer with a different geographic footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/sofiebio
• Xx.com/sofiebio
• Facebookfacebook.com/sofiebio

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds7 records

Investors6 records

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

M&A1 record

Investments

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

Frequently asked questions about SOFIE