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Actinium Pharmaceuticals, Inc. (ATNM) is a clinical-stage biopharmaceutical leader pioneering targeted radiotherapies for advanced cancers, with a focus on acute myeloid leukemia (AML) and stem cell transplant conditioning. This page provides investors and healthcare professionals with timely updates on the company’s clinical trials, regulatory milestones, and scientific advancements.
Access verified news about Actinium’s antibody radiation conjugate (ARC) pipeline, including Iomab-B and Actimab-A, alongside strategic partnerships in oncology. Our curated repository ensures efficient tracking of developments in targeted radiotherapy, clinical research collaborations, and progress toward addressing unmet needs in hematologic malignancies.
Explore updates across key categories: clinical trial results, FDA communications, intellectual property expansions, and scientific presentations. Bookmark this page to stay informed on Actinium’s innovative approaches to minimizing treatment toxicity while improving outcomes for high-risk cancer patients.
Actinium Pharmaceuticals (NYSE: ATNM) has presented promising preclinical results for ATNM-400, a novel targeted radiotherapy for prostate cancer, at the AACR Annual Meeting. The data shows ATNM-400 outperforms Pluvicto, achieving 99.8% tumor growth inhibition with a single 40 µCi/kg dose.
Unlike Pluvicto and most prostate cancer radiotherapies that target PSMA, ATNM-400 is a first-in-class treatment targeting a distinct non-PSMA receptor that remains highly expressed even after Pluvicto treatment. The therapy utilizes Actinium-225, a more potent alpha-particle emitter than Lutetitium-177, causing irreversible DNA breaks with potentially fewer off-target effects.
Key findings demonstrate ATNM-400's efficacy in Pluvicto-resistant tumors, rapid internalization, sustained tumor uptake, and efficient clearance from essential organs. The treatment was well-tolerated with no apparent toxicities at both tested dose levels.
Actinium Pharmaceuticals (NYSE: ATNM) presented data at the AACR Annual Meeting showcasing Actimab-A's mutation agnostic antileukemic effects in AML treatment. The preclinical studies demonstrated significant efficacy when combining Actimab-A with standard AML therapies against multiple mutations (FLT3, NPM1, KMT2A, and TP53).
Actimab-A, the only CD33-targeted radiotherapy using Actinium-225 isotope for AML treatment, showed enhanced tumor growth inhibition and prolonged survival when combined with various therapies including menin inhibitor revumenib, FLT3 inhibitor gilteritinib, and hypomethylating agent azacitidine.
The company is advancing multiple clinical trials, including a Phase 2/3 trial combining Actimab-A with CLAG-M in relapsed/refractory AML and another study with Venetoclax and ASTX-727 in frontline AML under an NCI CRADA. The addressable market spans over 100,000 patients in the U.S. and EU5.
Actinium Pharmaceuticals (NYSE: ATNM) has unveiled ATNM-400, a groundbreaking non-PSMA targeting radiotherapy for prostate cancer using Actinium-225. Initial preclinical data showed remarkable results with 99.8% tumor growth inhibition at 40 µCi/kg and 68.5% at 20 µCi/kg from a single dose.
The therapy demonstrated selective tumor accumulation for up to 144 hours with minimal uptake in healthy tissues. ATNM-400 differentiates itself from Novartis's Pluvicto by targeting a different marker than PSMA and utilizing the more potent alpha-particle emitter Ac-225, potentially resulting in fewer off-target effects.
The company will present initial data at the AACR Annual Meeting (April 25-30, 2025), including results from Pluvicto-resistant prostate cancer models. The presentation will showcase findings from in vitro and in vivo studies, biodistribution imaging, and efficacy analyses at various dose levels.
Actinium Pharmaceuticals (NYSE: ATNM) announced significant updates to its clinical pipeline, highlighting the introduction of ATNM-400, a novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer. Initial preclinical results will be presented at AACR on April 27, 2025.
The company is establishing radiopharmaceutical manufacturing infrastructure in 2025 and expects multiple clinical trial data readouts in H2 2025, including:
- Actimab-A frontline AML trial with NCI
- Solid tumor trials combining Actimab-A with KEYTRUDA and OPDIVO in HNSCC and NSCLC
- Iomab-ACT trials in commercial CAR-T and sickle cell disease
Actinium's pipeline now targets four multi-billion-dollar market opportunities. The company reports a strong balance sheet with cash runway extending into mid-2027.
Actinium Pharmaceuticals (NYSE: ATNM) announced a business update presentation at Trump Mar-a-Lago Club, following their March 25th Investor KOL Event. The company highlighted three key clinical programs targeting multi-billion-dollar markets:
1. Actimab-A for myeloid malignancies and solid tumors:
- Phase 2/3 trial in combination with CLAG-M for AML
- Clinical trials for solid tumors with PD-1 inhibitors
2. Iomab-ACT for cell & gene therapy conditioning:
- Commercial CAR-T trial data from UT Southwestern
- Sickle cell disease trial data from Columbia University
3. Infrastructure Development:
- Manufacturing facility build-out starting next quarter
- Proprietary Actinium-225 cyclotron technology development
The company reports a strong balance sheet with runway into mid-2027, with multiple clinical milestones expected in 2025.
Actinium Pharmaceuticals (NYSE: ATNM) announces a KOL investor call highlighting three major market opportunities for their targeted radiotherapies. The call features Dr. Ehab Atallah from Medical College of Wisconsin discussing Actimab-A clinical results and upcoming trials.
The company is pursuing three distinct multi-billion-dollar opportunities:
- Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies
- Actimab-A combined with PD-1 inhibitors (KEYTRUDA and OPDIVO) for solid tumors
- Iomab-ACT as a universal targeted conditioning agent for cell & gene therapies
The presentation will cover clinical proof of concept data from frontline AML trial under NCI CRADA, the new Actimab-A solid tumor program with checkpoint inhibitors, and Iomab-ACT commercial CAR-T trial, along with other 2025 milestones.
Actinium Pharmaceuticals (NYSE: ATNM) has secured a supply agreement with Eckert & Ziegler for Actinium-225 (Ac-225), a important radioisotope for targeted cancer therapies. The agreement will support the development of ATNM's lead product Actimab-A and other candidates for U.S. and international clinical trials.
Actimab-A, an Ac-225 based radiotherapy targeting CD33 receptors, is being developed for acute myeloid leukemia (AML) and other myeloid conditions. The company is advancing Actimab-A into a pivotal Phase 2/3 trial for relapsed/refractory AML and a Phase 1 trial in frontline settings with the NCI.
Additionally, ATNM is expanding Actimab-A's application to solid tumors, combining it with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO for head and neck squamous carcinoma and non-small cell lung cancer trials.
Actinium Pharmaceuticals (NYSE: ATNM) has announced a research collaboration with Memorial Sloan Kettering Cancer Center to expand Actimab-A's therapeutic applications. The partnership focuses on studying Actimab-A in combination with targeted therapies, particularly FLT3 and menin inhibitors, and assessing its activity in AML patient-derived samples.
Actimab-A has shown positive clinical results in high-risk relapsed and refractory AML patients, including those with TP53 gene mutation, prior Venetoclax treatment, and bone marrow transplant. The therapy demonstrates synergy with various inhibitors targeting mutations present in significant portions of AML cases: NPM1 and KMT2A (30%), FLT3 (25-30%), and IDH1&2 (10-20%).
The company is advancing Actimab-A into a pivotal Phase 2/3 trial in combination with CLAG-M chemotherapy for relapsed/refractory AML, and in newly diagnosed AML with Venetoclax and ASTX-727. Additionally, Actinium is developing Actimab-A for solid tumor indications, with planned trials combining it with KEYTRUDA® and OPDIVO® in HNSCC and NSCLC.
Actinium Pharmaceuticals (NYSE: ATNM) announced plans to host a KOL call featuring Dr. Ehab Atallah to discuss their pipeline developments and market opportunities. The company highlighted three potential multi-billion-dollar markets for their targeted radiotherapies:
1. Actimab-A for myeloid malignancies including AML and MDS
2. Actimab-A combined with KEYTRUDA® and OPDIVO® for solid tumors
3. Iomab-ACT as a universal targeted conditioning agent for cell & gene therapies
Key upcoming milestones include:
- Clinical proof of concept data for Actimab-A combinations in solid tumors (2H:2025)
- Initial clinical data from Actimab-A triplet combination in frontline AML (year-end 2025)
- Planned pivotal Phase 2/3 trial for Actimab-A + CLAG-M in r/r AML
- Iomab-ACT commercial CAR-T trial initiation and data expected in 2H:2025
The company reports having cash runway extending into 2027.