Radiopharmaceutical Innovation in Oncology: Strategic Momentum and Clinical Differentiation in Emerging Theranostics Platforms

The theranostics market is undergoing a transformative phase in oncology, driven by technological advancements, personalized medicine, and increased R&D investments. With the global theranostics market projected to grow at a compound annual growth rate (CAGR) of 28.7% from 2025 to 2032, reaching an estimated value of USD 27.76 billion by 2032, investors are increasingly turning their attention to companies that are pioneering novel approaches in this high-growth sector. Two emerging players, Radiopharm Theranostics and Archeus Technologies, are leveraging FDA clearances, expert partnerships, and novel isotopic therapies to build defensible positions in the theranostics market.

Radiopharm Theranostics: Targeted Therapies with Strategic Partnerships

Radiopharm Theranostics has made significant strides in the theranostics space with its FDA Investigational New Drug (IND) approval for RV-01, a B7-H3-targeting radiopharmaceutical. This clearance, achieved in 2025, validates the company's scientific innovation and underscores the growing demand for targeted therapies in solid tumors. RV-01, a Lu-177-labeled monoclonal antibody engineered to reduce off-target effects and kidney toxicity, is designed to address limitations in existing radiopharmaceutical therapies. The drug's rapid excretion and high tumor uptake, demonstrated in preclinical data, position it as a first-in-class therapy with potential applications in aggressive cancers such as glioblastoma, melanoma, and small-cell lung cancer.

Strategically, Radiopharm has leveraged this IND approval to strengthen its financial and partnership ecosystem. The company has reported a 20.9% reduction in net losses for the half-year ending December 2024, supported by cost controls and a $28,060 gain from contingent consideration. Its cash reserves have reached $36.4 million, bolstered by an $8 million equity placement with Lantheus Holdings, a major player in radiopharmaceuticals. Lantheus also increased its stake in Radiopharm to 12.16%, and the two companies entered a co-development agreement for a Phase 1 imaging trial involving RV-01. This partnership not only enhances Radiopharm's credibility but also provides access to Lantheus' manufacturing and commercialization expertise.

In addition to its partnership with Lantheus, Radiopharm has forged a strategic collaboration with MD Anderson Cancer Center, further strengthening its R&D capabilities and clinical trial infrastructure. The company also secured a $4 million investment to increase its ownership in Radiopharm Ventures, LLC, signaling confidence in the scalability of its preclinical and clinical programs. These strategic moves collectively position Radiopharm to navigate the high costs and complexities of drug development and to compete effectively in the theranostics space, particularly against larger biotechnology firms.

The company's financial resilience is further supported by its Nasdaq listing (ticker: RADX) in November 2024, which expanded access to U.S. capital markets and increased visibility among institutional investors. With a projected global theranostics market growth of 15.2% CAGR through 2030, reaching $5.4 billion, Radiopharm's focus on B7-H3—a biomarker associated with poor prognosis in multiple cancers—aligns with the growing trend of personalized medicine and radiopharmaceutical adoption in oncology. The company's pipeline includes both therapeutic and imaging agents, such as RV-01 and RAD101, aiming to capture both diagnostic and therapeutic segments of the market.

Looking ahead, the Phase 1 trial for RV-01 is scheduled to begin in Q4 2025 and will be a critical milestone in demonstrating the drug's safety and efficacy in humans. Investors are encouraged to monitor key developments, including enrollment in the first-in-human basket study, interim Phase 1 data, and the formation of new partnerships to secure manufacturing and distribution. While the path to commercialization remains long, Radiopharm's scientific differentiation, financial prudence, and strategic alliances make it an intriguing candidate for long-term investors. The IND approval for RV-01 represents not just a regulatory achievement but a validation of the company's ability to innovate in a competitive and high-stakes therapeutic area.

Archeus Technologies: Novel Isotopic Therapies and Academic Collaborations

Archeus Technologies has made significant progress in the theranostics space with multiple FDA clearances for its investigational radiopharmaceutical therapies. In October 2024, the FDA granted clearance to an Investigational New Drug (IND) application for ARC-706, Archeus' lead therapeutic candidate, and its companion diagnostic, ARC-166. These agents are being developed as a theranostic pair for use in combination with certain validated immunotherapies across a range of tumor types. Preclinical data suggest that ARC-706 may yield clinical activity and immune memory against tumors that were previously resistant to immunotherapy.

In June 2025, Archeus received FDA clearance for another novel receptor-based PSMA-targeting small molecule, ART-101, for the imaging and treatment of metastatic castration-resistant prostate cancer (mCRPC). This clearance enables the initiation of a Phase 1 clinical trial for ART-101, which is expected to begin later in the year. ART-101 is compatible with multiple therapeutic isotopes, including actinium-225, lutetium-177, and terbium-161, and preclinical studies have demonstrated higher tumor uptake and retention, along with lower uptake in normal tissues and salivary glands compared to current PSMA-targeting agents. These characteristics suggest the potential for greater efficacy and safety compared to existing standards of care.

Archeus has formed a strategic partnership with the Wisconsin Alumni Research Foundation (WARF), the patenting and licensing arm of the University of Wisconsin–Madison (UW), to advance the development of ART-101, a novel receptor-based targeting molecule for the treatment of prostate cancer. This collaboration is part of a broader effort to translate innovative radiopharmaceutical research into clinical applications. ART-101 was discovered and developed at the Advanced Radiotheranostics Lab at UW–Madison, led by Dr. Reinier Hernandez, an assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health. The molecule has demonstrated enhanced pharmacology in preclinical studies, including significantly higher tumor uptake and retention compared to the FDA-approved prostate cancer treatment Pluvicto® (177Lu-PSMA-617), as well as superior pharmacokinetics, dosimetry, and normal tissue toxicity profiles.

The molecule is compatible with multiple therapeutic isotopes, including actinium-225, lutetium-177, and terbium-161, which could enhance its therapeutic potential for prostate cancer treatment. Archeus plans to evaluate ART-101 as a theranostic radiopharmaceutical agent capable of delivering alpha-emitting isotopes with greater tolerability and efficacy compared to current standards of care. The company has received FDA clearance of its Investigational New Drug (IND) application for ART-101, which will enable the initiation of a Phase 1 clinical trial in 2025 for men with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 trial is expected to provide critical insights into the safety, tolerability, and therapeutic potential of ART-101 in human subjects.

In addition to ART-101, Archeus has a growing pipeline of radiopharmaceutical therapies and companion diagnostic assets. The company received IND clearances in October 2024 for its lead therapeutic candidate, ARC-706, and its companion diagnostic, ARC-166, which are being developed as a theranostic pair. These agents are intended for use in combination with certain validated immunotherapies across a range of cancer types. Preclinical data suggest that ARC-706 may produce curative responses and generate immune memory against cancers that are otherwise resistant to these immunotherapies. Clinical development of these agents is also expected to begin in 2025.

Archeus Technologies is led by an executive team with extensive radiopharmaceutical expertise, including CEO Evan Sengbusch, who has a background in medical physics and business development in nuclear medicine and radiopharmaceutical technologies. The company also benefits from a long-standing collaboration with the University of Wisconsin–Madison and is supported by a strong advisory board, including experts in oncology, radiopharmaceutical development, and clinical trials.

The Wisconsin Alumni Research Foundation (WARF) plays a crucial role in supporting Archeus' development through its investment and commercialization initiatives, including the WARF Accelerator and WARF Therapeutics. These programs aim to improve the commercialization potential of university intellectual property and drug candidates by engaging with industry partners and validating market potential. WARF's involvement underscores its commitment to advancing cutting-edge technologies and therapeutic candidates that have the potential to significantly improve cancer treatment options and patient outcomes.

Strategic Momentum and Clinical Differentiation: A Comparative Analysis

Both Radiopharm Theranostics and Archeus Technologies are leveraging FDA clearances, expert partnerships, and novel isotopic therapies to build defensible positions in the high-growth theranostics market. Radiopharm's focus on B7-H3, a biomarker associated with poor prognosis in multiple cancers, aligns with the growing trend of personalized medicine and radiopharmaceutical adoption in oncology. The company's strategic partnership with Lantheus and its collaboration with MD Anderson Cancer Center provide it with the resources and expertise needed to navigate the high costs and complexities of drug development.

Archeus Technologies, on the other hand, is leveraging its collaboration with the University of Wisconsin–Madison and the Wisconsin Alumni Research Foundation to develop novel isotopic therapies with the potential to improve outcomes for patients with advanced cancer. The company's pipeline of radiopharmaceutical therapies and companion diagnostic assets, including ART-101 and ARC-706, highlights its commitment to developing innovative treatments with the potential to address unmet medical needs in oncology.

While both companies are making significant strides in the theranostics space, their approaches differ in key areas. Radiopharm's focus on B7-H3 and its strategic partnerships with industry leaders position it to capture both diagnostic and therapeutic segments of the market. Archeus Technologies' collaboration with academic institutions and its focus on novel isotopic therapies position it to develop innovative treatments with the potential to improve outcomes for patients with advanced cancer.

Investment Insights and Recommendations

The theranostics market is expected to grow at a CAGR of 28.7% from 2025 to 2032, reaching an estimated value of USD 27.76 billion by 2032. This growth is driven by the increasing prevalence of cancer and the rising demand for targeted and personalized treatment options, particularly in oncology. As the market continues to expand, the integration of AI, the development of new radioisotopes, and the expansion of companion diagnostics are expected to play a central role in shaping the future of cancer treatment.

For investors, the key to success in the theranostics market lies in identifying companies that are leveraging strategic partnerships, expert collaborations, and novel isotopic therapies to build defensible positions in this high-growth sector. Radiopharm Theranostics and Archeus Technologies are two such companies that are well-positioned to capitalize on the growing demand for targeted and personalized treatment options in oncology.

Radiopharm Theranostics' focus on B7-H3, its strategic partnership with Lantheus, and its collaboration with MD Anderson Cancer Center position it to capture both diagnostic and therapeutic segments of the market. The company's financial resilience, supported by its Nasdaq listing and its ability to secure capital through equity placements and partnerships, further strengthens its position in the theranostics space.

Archeus Technologies' collaboration with the University of Wisconsin–Madison and the Wisconsin Alumni Research Foundation, along with its focus on novel isotopic therapies, positions it to develop innovative treatments with the potential to improve outcomes for patients with advanced cancer. The company's pipeline of radiopharmaceutical therapies and companion diagnostic assets, including ART-101 and ARC-706, highlights its commitment to developing innovative treatments with the potential to address unmet medical needs in oncology.

Given the high-growth potential of the theranostics market and the strategic momentum of these two companies, investors should consider Radiopharm Theranostics and Archeus Technologies as compelling long-term investment opportunities. Both companies are well-positioned to benefit from the growing demand for targeted and personalized treatment options in oncology, and their ability to leverage strategic partnerships and expert collaborations will be critical to their success in this high-growth sector.