The Race for the Global Radiotherapy Cancer Market; Actinium Pharmaceuticals' (ATNM) Big Bet
Actinium Pharmaceuticals (NYSE: ATNM) is prioritizing ATNM-400, an Ac-225 alpha-emitter pan-tumor candidate, alongside clinical assets Actimab-A and Iomab-ACT as it targets the growing targeted radiotherapy market. Actinium lists ~250 issued and pending patents and reports preclinical data showing ATNM-400 produced superior tumor control versus 177Lu-PSMA-617 and achieved 40% complete tumor regressions in combination with enzalutamide in animal models. The company disclosed a competitive and regulatory backdrop including a Novartis objection letter (Aug 2025) and noted market context where RLT is estimated at $25–$30B and Pluvicto sales reached about $1.4B in early 2025.
Actinium Pharmaceuticals (NYSE: ATNM) sta dando priorità a ATNM-400, un candidato alpha-emitter Ac-225 pan-tumore, insieme agli asset clinici Actimab-A e Iomab-ACT, mentre punta al mercato in crescita della radioterapia mirata. Actinium annota circa 250 brevetti emessi e in sospeso e riporta dati preclinici che mostrano che ATNM-400 ha prodotto un controllo del tumore superiore rispetto a 177Lu-PSMA-617 e ha raggiunto 40% di regressioni tumorali complete in combinazione con enzalutamide in modelli animali. L'azienda ha divulgato un contesto competitivo e regolatorio tra cui una lettera di opposizione di Novartis (agosto 2025) e ha sottolineato il contesto di mercato in cui la radioterapia mirata (RLT) è stimata tra 25 e 30 miliardi di dollari e le vendite di Pluvicto hanno raggiunto circa 1,4 miliardi di dollari all'inizio del 2025.
Actinium Pharmaceuticals (NYSE: ATNM) está priorizando ATNM-400, un candidato de emisor alfa Ac-225 para múltiples tumores, junto con activos clínicos Actimab-A y Iomab-ACT, ya que apunta al creciente mercado de radioterapia dirigida. Actinium lista ~250 patentes emitidas y pendientes y reporta datos preclínicos que muestran que ATNM-400 logró un mejor control tumoral frente a 177Lu-PSMA-617 y alcanzó un 40% de reducciones completas de tumores en combinación con enzalutamida en modelos animales. La compañía divulgó un trasfondo competitivo y regulatorio que incluye una carta de objeción de Novartis (agosto de 2025) y señaló el contexto de mercado donde la RLT se estima en 25–30 mil millones de dólares y las ventas de Pluvicto alcanzaron alrededor de 1,4 mil millones a principios de 2025.
Actinium Pharmaceuticals (NYSE: ATNM)는 ATNM-400을 최우선으로 두고, Ac-225 알파 방출제 팬-투뭄어 후보 물질로서 Actimab-A 및 Iomab-ACT의 임상 자산과 함께 성장하는 표적 방사선 치료 시장을 공략합니다. Actinium은 약 250개의 발행 및 특허 출원 중임을 밝히고 있으며, 전임상 데이터에서 ATNM-400이 177Lu-PSMA-617 대비 종양 억제에 우수한 성능을 보였고 동물 모델에서 엔잘루타마이드와 병용 시 40%의 종양 완전 관해를 달성했다고 보고합니다. 또한 회사는 노바티스의 이의 제기 서한(2025년 8월) 등 경쟁 및 규제 맥락을 공개했고, 시장 맥락에서 RLT가 250억~300억 달러 규모로 추정되며 Pluvicto 매출이 2025년 초 약 14억 달러에 이른다고 지적했습니다.
Actinium Pharmaceuticals (NYSE: ATNM) donne la priorité à ATNM-400, un candidat α-émiteur Ac-225 pan-tumeur, aux côtés des actifs cliniques Actimab-A et Iomab-ACT, alors qu'elle vise le marché croissant de la radiothérapie ciblée. Actinium indique environ 250 brevets émis et en attente et rapporte des données précliniques montrant que ATNM-400 a produit un meilleur contrôle des tumeurs par rapport au 177Lu-PSMA-617 et a atteint 40% de rémissions complètes des tumeurs en association avec l'enzalutamide dans des modèles animaux. L'entreprise a divulgué un contexte compétitif et réglementaire comprenant une lettre d'objection de Novartis (août 2025) et a noté le contexte du marché où la radiothérapie ciblée interne (RLT) est estimée entre 25 et 30 milliards de dollars et les ventes de Pluvicto ont atteint environ 1,4 milliard de dollars début 2025.
Actinium Pharmaceuticals (NYSE: ATNM) priorisiert ATNM-400, einen Ac-225-Alpha-Emitter Pan-Tumor-Kandidaten, neben den klinischen Assets Actimab-A und Iomab-ACT, während es den wachsenden Markt der zielgerichteten Radiotherapie anvisiert. Actinium listet etwa 250 erteilte und anhängige Patente auf und berichtet über präklinische Daten, die zeigen, dass ATNM-400 eine bessere Tumorkontrolle gegenüber 177Lu-PSMA-617 erzielte und in Kombination mit Enzalutamid in Tiermodellen zu 40% vollständigen Tumorrückbildungen führte. Das Unternehmen legte einen wettbewerbsorientierten und regulatorischen Hintergrund offen, darunter ein Einwandschreiben von Novartis (August 2025) und wies auf den Markt-context hin, in dem RLT auf geschätzt 25–30 Mrd. USD und Pluvicto-Umsätze Anfang 2025 bei ca. 1,4 Mrd. USD lagen.
Actinium Pharmaceuticals (NYSE: ATNM) تعطي الأولوية لـ ATNM-400، وهو مُصدِر ألفا Ac-225 عابر للأنسجة، إلى جانب الأصول السريرية Actimab-A و Iomab-ACT، فيما تستهدف سوق العلاج الإشعاعي المستهدف المتنامي. تسرد Actinium نحو 250 براءة اختراع صادرة وقيد الانطلاق وتعرض بيانات ما قبل السريرية تُظهر أن ATNM-400 حقق تحكماً أقوى في الورم مقارنة بـ 177Lu-PSMA-617 وحقق نسبة 40% من الانحدارات الكلية للورم عند الجمع مع الإنزلالوتاميد في نماذج حيوانية. كشفت الشركة عن خلفية تنافسية وتنظيمية تشمل رسالة اعتراض من نوفارتس (أغسطس 2025) وأشارت إلى سياق السوق حيث يُقدَّر حجم RLT بين 25 و30 مليار دولار وبلغت مبيعات Pluvicto نحو 1.4 مليار دولار في أوائل 2025.
- ATNM-400 showed superior tumor control vs 177Lu-PSMA-617 in preclinical studies
- 40% complete tumor regressions in animals with ATNM-400 plus enzalutamide
- Approximately 250 issued and pending patents worldwide
- Actimab-A is an advanced clinical-stage product candidate
- ATNM-400 remains preclinical, exposing timeline and clinical-risk
- Aug 2025 Novartis objection letter raises competitive/legal uncertainty
- More than 30 PSMA-targeted radiotherapies in development increases competition
Insights
Actinium frames ATNM-400 and Actimab-A as differentiated targeted radiotherapies; opportunity depends on preclinical-to-clinic translation and regulatory/competitive responses.
Actinium is positioning ATNM-400 as a first-in-class Ac-225 alpha-emitter with preclinical activity in prostate, NSCLC and breast cancer, and highlights Actimab-A and Iomab-ACT for hematology and conditioning. The company cites
Key dependencies and risks are clear in the disclosures: ATNM-400 remains preclinical and comparisons to approved agents prompted a formal letter from Novartis, indicating competitive and legal sensitivity around claims. Clinical translation, tolerability of Ac-225 constructs, regulatory acceptance of comparative claims, and successful demonstration of synergy with ARPIs are material gates. The presence of many other RLT programs and recent large collaborations (for example between Lilly and other developers) underlines competitive intensity.
Concrete items to watch include completion of preclinical programs and entry into first-in-human studies for ATNM-400, clinical milestones for Actimab-A, any formal responses or filings related to the Novartis letter, and regulatory filings tied to competing products such as the referenced Pluvicto® FDA filing activity in
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - November 17, 2025) - Investorideas.com, a go-to investing platform covering biotech and pharma stocks issues a snapshot looking at the radiotherapy cancer market, featuring Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), a pioneer in the development of differentiated, targeted radiotherapies intended to meaningfully improve outcomes for patients with advanced cancers. Actinium is deploying its technologies, capabilities and intellectual property with approximately 250 issued and pending patents worldwide, to develop next-generation radiotherapies focused on solid tumors, hematology and conditioning for cellular therapies.
The Race for the Global Radiotherapy Cancer Market; Actinium Pharmaceuticals' (ATNM) Big Bet
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The targeted radiotherapies for cancer market is experiencing significant growth, driven by advancements in technology and investment.
The cancer radiotherapy market, particularly the radioligand therapy (RLT) segment, is expanding swiftly. Novartis (NYSE: NVS), a dominant player in this arena, is targeting RLT revenue by broadening its portfolio of approved treatments and advancing its development pipeline. According to multiple sources, Novartis CEO Vas Narasimhan has estimated that the market for radioligand therapy (RLT) could be valued at between
Also reported in a Briefglance.com recent article, "Novartis is bolstering its position in the rapidly expanding field of targeted cancer therapy with a new radioligand therapy (RLT) manufacturing facility in Carlsbad, California. The investment underscores the growing demand for personalized cancer treatments and positions Novartis to capitalize on a market projected for significant growth over the next decade."
Continued:
Novartis's Pluvicto, approved for prostate cancer sales exceeded
Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reporting in its recent 10Q filing: "Recently prioritized as our lead program, ATNM-400, is a highly innovative, first-in-class, and pan-tumor Actinium-225 ("Ac-225") alpha-emitter targeted radiotherapy candidate with preclinical data in prostate cancer, non-small cell lung cancer ("NSCLC") and breast cancer.
"We believe ATNM-400 has the potential to address critical gaps across multiple treatment settings in each of these targeted indications and can therefore address large patient populations. Actimab-A is our most advanced clinical-stage product candidate, which utilizes an antibody linked to Ac-225 to target CD33, a cell surface protein that Actimab-A is designed to target, that is expressed ubiquitously in acute myeloid leukemia ("AML") and myelodysplastic syndromes ("MDS") and on myeloid derived suppressor cells ("MDSC")."
"We are evaluating Actimab-A's potential to synergize with immune checkpoint inhibitors ("ICIs") such as programmed cell death 1 ("PD-1) inhibitors in solid tumors by depleting MDSC immune cells. Iomab-ACT is our next-generation targeted conditioning agent we are developing with the intent to improve patient access to, and outcomes with, cellular therapies such as CAR-T for various blood cancer indications and gene therapies for non-malignant hematologic disorders such as sickle cell disease ("SCD")."
Commenting on the market opportunity in their 10Q, Actinium notes,"With the approval of Novartis' (NYSE: NVS) Pluvicto® for patients with mCRPC post-taxane therapy and post ARPI therapy and prior to taxane therapy, targeted-radiotherapy has become a prominent component of the metastatic prostate cancer treatment paradigm. Pluvicto® generated sales of approximately
Continued:
"In August 2025, we received a letter from Novartis Pharmaceuticals Corporation (the "Novartis Letter") that is incorporated in this Form 10-Q as an exhibit. In that letter, Novartis strongly objected to statements that Actinium made comparing ATNM-400 and Pluvicto®. Given that ATNM-400 is in preclinical development and that we clearly indicated as such, we believe that the Novartis Letter is highly unusual. We believe the particular statements cited by Novartis were not misleading and were accurate depictions of our research findings that evaluated ATNM-400 versus 177Lu-PSMA-617, the active agent in Pluvicto® as well as 225Ac-PSMA-617, a targeted radiotherapy that is not yet approved but is being evaluated by multiple companies including Novartis. As we have reported, ATNM-400 demonstrated superior tumor control and improved overall survival in preclinical studies in prostate cancer bearing animals compared to 177Lu-PSMA-617. In addition, ATNM-400 demonstrated efficacy in prostate cancer tumors that developed resistance to 177Lu-PSMA-617. Therefore, we do not agree with any of the claims made in the Novartis Letter and do not believe Novartis has requisite legal authority or basis to challenge Actinium. Therefore, we have not responded to Novartis but reserve all rights. We believe patients with mCRPC have high unmet needs that are not addressed by current therapies including Pluvicto® and intend to continue to develop ATNM-400 with the goal of addressing these patient needs.
Continued:
"With the only approved targeted radiotherapy in prostate cancer moving up in the treatment paradigm with very few differentiated products in clinical development, we believe there is a significant potential market opportunity for ATNM-400. Currently, over 30 PSMA-targeted radiotherapies are in various stages of development, of which few offer a substantial efficacy advantage compared to Pluvicto®. Re-treatment with PSMA-targeting agents has not yet been supported substantially in controlled clinical trials and could be less effective than targeting a different antigen due to potential reduction of PSMA surface expression as well as increased tumor heterogeneity following initial PSMA-targeted therapy.
Continued:
"We have demonstrated that ATNM-400's differentiated target is expressed and druggable following ARPI therapy and PSMA radiotherapy. We believe ATNM-400 can therefore target a significant subset of the mCRPC patient population with aggressive disease who progressed on second generation ARPIs or have had no response to or progressed on Lu-177 labelled PSMA-targeted therapy. As ATNM-400 does not target PSMA, xerostomia or dry mouth, which can be a significant quality of life issue for patients with metastatic prostate cancer receiving PSMA-targeted radiotherapies as PSMA is expressed on salivary glands, would not be expected. Additionally, the antigen targeted by ATNM-400 is implicated in a pathway leading to ARPI-resistance in mCRPC patients and expression increases post-ARPI treatment; therefore, along with the tumor suppressing ability of Ac-225, ATNM-400 displays a compelling mechanism for synergy with ARPIs. This mechanistic synergy is supported by the complete tumor regression in 40 percent of tumor bearing animals treated with the combination of ATNM-400 and the ARPI enzalutamide. As a result, we believe ATNM-400 has the potential to address critical gaps in prostate cancer treatment as a monotherapy or in combination or sequenced with other therapeutic modalities."
SEC filing https://ir.actiniumpharma.com/all-sec-filings#document-3317-0001213900-25-110979
Looking at other companies in the market which are taking a different approach, in September, Lila Biologics an AI/ML-driven protein therapeutics biotech company announced a global licensing and multi-target research collaboration with Eli Lilly and Company ( NYSE: LLY) focused on the discovery, development, and commercialization of novel radioligand therapies (RLTs) for imaging and treatment of solid tumors. Lila also announced the launch of its two protein therapeutic platforms, driven by artificial intelligence (AI) and machine learning (ML), to combat cancer and non-oncology diseases. Lila's targeted radiotherapy (TRT)/oncology platform for solid tumors and long-acting injectables (LAI) platform for non-oncology conditions are utilizing Lila's proprietary AI/ML-powered protein design engine to create the foundation for new drug discovery and breakthrough treatments for patients.
From the news:
"We are on a mission to transform patient care by harnessing machine learning-powered protein design and advanced technologies to deliver life-changing therapies to patients," said Jake Kraft, CEO and co-founder of Lila Biologics. "Lila's core technology goes beyond ML-enabled design of high-affinity binders, and we've fine-tuned our engine to deliver precision targeted proteins with optimized drug-like properties that have the potential to unlock a new generation of treatments that dramatically improve patients' quality of life and extend survival time."
Earlier in the year, Eli Lilly and Company ( NYSE: LLY) entered into another collaboration in the sector. AdvanCell, a clinical-stage radiopharmaceutical company specializing in targeted alpha therapies, announced an expansion to the scope and breadth of its strategic collaboration with Eli Lilly and Company to research and develop innovative treatments for various cancers.
From the news:
Under this new agreement, the parties will leverage AdvanCell's proprietary Pb-212 production technology and radionuclide development infrastructure and Lilly's drug candidate programs and extensive expertise in drug development to facilitate the development and accelerate the clinical advancement of an expanded portfolio of targeted alpha therapies.
Continued:
AdvanCell's competitive advantage in technology development and the infrastructure it has built to accelerate early-stage clinical trials in Australia enables AdvanCell to rapidly develop and progress novel Pb-212-containing radiotherapeutics from discovery into clinical trials.
Continued:
"This collaboration with Lilly represents a significant milestone for AdvanCell, recognizing our company as one of the leaders in the Pb-212 targeted alpha therapy space," said Andrew Adamovich, CEO of AdvanCell. "By combining our groundbreaking isotope production capabilities, our team's expertise and infrastructure with Lilly's pharmaceutical and oncology expertise and global scale, we aim to bring transformative treatments to patients with hard-to-treat cancers. It is especially pleasing to continue and expand our existing relationship."
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FAQ
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