Core Insights - Actinium Pharmaceuticals has developed Iomab-B, the first CD45 targeted radiotherapy aimed at enabling potentially curative bone marrow transplants, representing an alternative to traditional chemotherapy approaches [1][6] - The Phase 3 SIERRA trial demonstrated significant efficacy, achieving durable Complete Remission and Event-Free Survival with high statistical significance [1][3] - Actinium plans to seek a strategic partner for further development of Iomab-B in the U.S. after completing FDA interactions for an additional clinical trial [1][6] Study Details - The SIERRA trial was a randomized, multicenter, controlled study involving 153 patients aged 55 and above with active relapsed or refractory Acute Myeloid Leukemia [2] - Patients receiving Iomab-B showed a 22% rate of durable Complete Remission compared to 0% in the control group, with a p-value of <0.0001 [3] - The trial also achieved a significant improvement in Event-Free Survival with a Hazard Ratio of 0.22 and a p-value of <0.0001 [3] Future Development - Despite positive results, the SIERRA trial did not meet the overall survival endpoint due to a high crossover rate, with nearly 60% of control patients receiving Iomab-B [3][5] - Actinium is focused on finalizing the specifics of an additional Phase 3 randomized trial to demonstrate overall survival benefits as required by the FDA for a Biologics License Application [6] - The company aims to accelerate the availability of Iomab-B for patients with high unmet needs in the context of bone marrow transplants [6][7]

Core Viewpoint - Actinium Pharmaceuticals, Inc. is under investigation for potential claims following a significant stock drop after the FDA's decision regarding its Biologics License Application for Iomab-B [2][3]. Investigation Details - On August 5, 2024, Actinium announced that the FDA deemed the Phase 3 SIERRA trial insufficient to support a BLA filing for Iomab-B, despite achieving a statistically significant primary endpoint [2]. - Following this announcement, Actinium's stock plummeted nearly 60% on the same day [2]. Next Steps - Investors who have information related to the investigation or who purchased Actinium securities are encouraged to assist by visiting the firm's website or contacting the firm's representatives [3]. Legal Representation - Bronstein, Gewirtz & Grossman, LLC operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and attorney fees if successful in the case [4]. Firm Background - Bronstein, Gewirtz & Grossman, LLC is a recognized firm specializing in representing investors in securities fraud class actions and has recovered hundreds of millions of dollars for investors across the nation [5].

Core Viewpoint - The Schall Law Firm is investigating Actinium Pharmaceuticals, Inc. for potential violations of securities laws related to misleading statements and failure to disclose important information to investors [1] Group 1: Company Overview - Actinium Pharmaceuticals, Inc. is focused on developing treatments for acute myeloid leukemia, specifically through its product Iomab-B [1] - The company announced a regulatory update regarding its Biologics License Application (BLA) filing for Iomab-B on August 5, 2024 [1] Group 2: Regulatory and Market Impact - The FDA has determined that the Phase 3 SIERRA trial is insufficient to support a BLA filing for Iomab-B, despite the trial meeting its statistically significant primary endpoint [1] - Following this announcement, Actinium's shares experienced a significant decline, falling by almost 60% on the same day [1]

Product Development and Clinical Trials - Actinium Pharmaceuticals is developing Iomab-B and Actimab-A to improve outcomes for patients with relapsed or refractory acute myeloid leukemia (r/r AML) [74] - The Phase 3 SIERRA trial for Iomab-B enrolled 153 patients, achieving a durable Complete Remission (dCR) rate of 22% compared to 0% in the control arm, with a p-value of <0.0001 [82] - Actinium has received positive feedback from the FDA regarding the Chemistry, Manufacturing and Controls (CMC) package for Iomab-B, but requires an additional clinical study to demonstrate overall survival benefit [81] - Actimab-A has been studied in approximately 150 patients across six clinical trials, showing potential as a backbone therapy in AML due to its mutation-agnostic ability [86] - Actinium has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to accelerate the development of Actimab-A [87] - Actinium plans to seek a strategic partner for Iomab-B in the U.S. following further discussions with the FDA regarding the additional clinical trial [84] - Iomab-ACT is being studied for conditioning prior to CAR-T therapy, with a Phase 1 trial showing no patients developed ICANS, compared to a 25% incidence in typical cases [90] - The company has received FDA clearance for an IND to study Iomab-ACT as targeted conditioning prior to commercial CAR-T therapy, marking a significant advancement in clinical trials [91] Market Opportunities - The EUMENA market opportunity for Iomab-B is estimated at approximately 7,200 bone marrow transplants (BMTs) performed in AML patients, which is about twice the number of BMTs performed in the U.S. [84] - The CAR-T market is projected to grow at a CAGR of approximately 11% over the next five years, with total sales exceeding $3.5 billion in 2023 [93] - The addressable patient population for CAR-T and gene therapies is expected to nearly double to approximately 93,000 patients in the U.S. by 2030 [93] Financial Performance - The company reported a net loss of $11.353 million for the three months ended June 30, 2024, compared to a net loss of $15.181 million for the same period in 2023, indicating a reduction in losses [111] - Research and development expenses decreased to $8.825 million in Q2 2024 from $11.081 million in Q2 2023, reflecting a 20.3% reduction [111] - Total operating expenses decreased to $12.418 million in Q2 2024 from $15.642 million in Q2 2023, a decline of 20.8% [111] - General and administrative expenses for the three months ended June 30, 2024, were $3.6 million, down from $4.6 million in the same period of 2023, a decrease of $1.0 million [119] - Net loss for the three months ended June 30, 2024, was $11.4 million, a decrease of $3.8 million from $15.2 million for the same period in 2023 [121] - Research and development expenses for the six months ended June 30, 2024, were $15.5 million, a decrease of $3.4 million from $18.9 million in the same period of 2023 [125] - General and administrative expenses for the six months ended June 30, 2024, were $6.6 million, down from $8.3 million in the same period of 2023, a decrease of $1.7 million [126] - Net loss for the six months ended June 30, 2024, was $20.0 million, a decrease of $6.2 million from $26.2 million for the same period in 2023 [128] - Cash used in operating activities for the six months ended June 30, 2024, was $15.3 million, a decrease of $13.4 million from $28.7 million in the prior-year period [132] - Cash provided by financing activities for the six months ended June 30, 2024, was $24.7 million, compared to $10.8 million for the same period in 2023 [132] - No commercial revenue was recorded for the three months ended June 30, 2024, and June 30, 2023 [113] Intellectual Property and Technology - Actinium's technology platform is supported by over 235 issued and pending patents worldwide, indicating a strong intellectual property position [72] - The patent portfolio includes over 235 issued patents and pending applications worldwide, providing a strong foundation for the company's intellectual property strategy [107] - The proprietary technology for producing Ac-225 is expected to reduce costs to between $650 and $1,000 per mCi, which is 10 to 20 times less expensive than current methods [100] Operational Outlook - As of the date of filing, the company expects existing resources to be sufficient to fund planned operations for more than 12 months [134] - As of June 30, 2024, the company's cash equivalents primarily consisted of short-term money market funds, indicating a low-risk profile [142] - The company is not currently exposed to significant market risk related to changes in interest rates, with an immediate 10% change in interest rates not materially affecting its financial position [142] - There is no significant exposure to foreign currency exchange rate fluctuations at present, although future operations may be subject to such risks [142] - Inflation has generally increased labor and clinical trial costs, but it did not have a material effect on the company's business or financial results during the six months ended June 30, 2024 and 2023 [143]

FDA determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpointAdditional head-to-head randomized clinical trial demonstrating overall survival benefit with Iomab-B is required by FDA to support a BLA filingActinium to request a meeting with the FDA to further discuss specifics of additional trialActinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development ef ...

- Sickle cell disease affects approximately 100,000 patients in the U.S. annually and is a debilitating and lifethreatening condition with high unmet need - Current conditioning with non-targeted chemotherapies provides limited access to potentially curative bone marrow transplant and recently approved gene therapies for sickle cell disease patients - Initial trial focused on conditioning for bone marrow transplant intended to inform subsequent gene therapy conditioning study and provide broader access to c ...

Presentation to highlight positive outcomes of Iomab-B led bone marrow transplant in difficult to treat TP53 patients and the mutation-agnostic mechanism of Actimab-A for patients with relapsed or refractory acute myeloid leukemiaIomab-B and Actimab-A represent the only clinical stage antibody radiation conjugates in development for patients with acute myeloid leukemiaNEW YORK, July 25, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the devel ...

Low-cap biotech companies are a high-risk but high-reward investment choice. If their clinical trials are successful, that can often mean an explosion in value as investors anticipate a buyout. However, if they fail, that may mean the end of the road for these companies. Here is a list of promising biotechs priced under $10 that could offer a huge return on investment in the coming months.Actinium Pharmaceuticals (ATNM)Source: ShutterstockActinium Pharmaceuticals (NYSEMKT:ATNM) is a biotech working on targe ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Actinium Pharmaceuticals (ATNM) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Actinium Pharmaceuticals is a member of our Medical group, which includes 1042 different companies and currently sits at #6 in the ...

PALM BEACH, Fla., June 17, 2024 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - According to a report from Mordor Intelligence the Acute Myeloid Leukemia Market size is estimated at USD 1.83 billion in 2024, and is expected to reach USD 2.97 billion by 2029, growing at a CAGR of 10.15% during the forecast period (2024-2029). The report said: "Key factors propelling the growth of this market are the high incidence and prevalence of acute myeloid leukemia, advancements in pharmacology and molecular biolo ...