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NEW YORK - Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM), which has seen its stock surge nearly 10% in the past week according to InvestingPro data, has reported positive outcomes from a clinical trial of Actimab-A combined with CLAG-M chemotherapy in patients with relapsed or refractory acute myeloid leukemia (r/r AML). The company’s shares have experienced significant volatility over the past year, trading between $1.03 and $10.24. Published in the peer-reviewed journal Leukemia, the study indicates a median overall survival of 18.4 months for patients who had previously undergone one or two lines of therapy.
The trial, which took place at the Medical College of Wisconsin, showed that 52% of participants had TP53 mutations and 56% had previously received Venetoclax treatment. The combination of Actimab-A and CLAG-M led to a high rate of measurable residual disease negativity, reaching 75% across all patients, and 100% in those with prior Venetoclax therapy. These results represent a significant improvement compared to historical data in the pre-Venetoclax era, which showed a median overall survival of 13.3 months with CLAG-M alone.
Actimab-A, a CD33 targeting radiotherapeutic, leverages the Actinium-225 isotope and has demonstrated potential as a backbone therapy in AML and other myeloid malignancies. The encouraging trial results support the mutation agnostic potential of Actimab-A and its ability to induce deep remissions, thus improving access to potentially curative bone marrow transplants and enhancing survival outcomes.
Dr. Sameem Abedin, the Principal Investigator of the study, expressed optimism about the combination’s high response rates and the forthcoming Phase 2/3 trial, which aims to further evaluate the efficacy of Actimab-A + CLAG-M in r/r AML patients.
Actinium is also engaged in a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for the development of Actimab-A in AML and other myeloid malignancies, including a trial of a triplet combination with Venetoclax and ASTX-727 in frontline AML patients.
The company’s strategic focus remains on addressing the needs of over 100,000 patients with AML and MDS in the U.S. and Europe, aiming to capitalize on Actimab-A’s multi-billion-dollar market opportunity. InvestingPro data shows the company maintains strong financial health with a current ratio of 10.25, indicating robust liquidity to fund its development programs. While operating with moderate debt levels, analysts anticipate continued investment in research and development will impact near-term profitability. As Actinium prepares for the pivotal Phase 2/3 trial expected to commence in 2025, the results published in Leukemia add to the momentum for Actimab-A’s potential as a treatment for high-risk AML patients.
This news is based on a press release statement from Actinium Pharmaceuticals, Inc. As a niche player in the biotechnology sector, Actinium’s financial metrics and growth potential are closely monitored by analysts. For deeper insights into Actinium’s financial health, valuation metrics, and additional analyst recommendations, InvestingPro subscribers have access to over 10 additional key insights and detailed financial analysis tools.
In other recent news, Actinium Pharmaceuticals has initiated a clinical trial in collaboration with the National Cancer Institute to evaluate a novel triplet combination therapy for patients with newly diagnosed acute myeloid leukemia (AML). This trial will assess the safety and efficacy of Actimab-A when combined with Venetoclax and ASTX-727. The combination aims to target a broader patient population, including those with high-risk mutations. Actimab-A is a targeted radiotherapy that delivers radiation directly to cancerous cells, potentially offering a more durable remission for AML patients. The trial is a significant step towards establishing Actimab-A as a foundational therapy for AML and other myeloid malignancies. Actinium’s Chief Medical Officer, Dr. Avinash Desai, expressed optimism about the potential of this therapy to produce deeper and more durable remissions. The company plans to generate preclinical data and initiate additional clinical trials throughout 2025. Actinium’s strategy focuses on leveraging its targeted radiotherapy platform for various cancers, supported by a robust intellectual property portfolio.
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