Actinium Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, develops targeted radiotherapies to deliver cancer-killing radiation to treat patients with high unmet medical needs. Its lead product candidate, Iomab-B (I-131 apamistamab) that is in a pivotal Phase III clinical trial for people with relapsed and refractory acute myeloid leukemia for bone marrow transplant; and a Phase I study with a CD19- targeted CAR T-cell therapy with memorial sloan kettering cancer center. The company offers clinical and preclinical development programs that utilize multiple isotopes, including Actinium-225, Iomab-ACT for GeneTx and cell therapy conditioning, Actimab-A (CD33) and CLAG-M, Actimab-A (CD33) and Venetoclax, and Actimab-A (CD33) and Venetoclax with HMA. It has collaboration with Astellas Pharma, Inc. to develop theranostics for solid tumor indications; EpicentRx, Inc that focuses on a novel CD47 -SIRPa immunotherapy targeted radiotherapy; and Immedica pharma for licensed the rights to commercialize Iomab-B. The company is based in New York, New York.

Actinium Pharmaceuticals, Inc. (Delaware)

Health care stocks fell Monday with the NYSE Health Care Index down 2.9% and the Health Care Select Sector SPDR Fund (XLV) dropping 2.6%.
The iShares Biotechnology ETF (IBB) fell 2.8%.
In corporate news, BioNTech (BNTX) reported a wider-than-expected loss in Q2 as global sales of the German drugmaker's COVID-19 vaccine fell amid weak demand. The stock slumped 4.4%.
Moderna (MRNA) is facing "material headwinds" for its vaccines for respiratory syncytial virus and COVID, RBC Capital Markets said in a report. RBC downgraded Moderna to sector perform from outperform and cut its price target to $90 from $125. Moderna shares were falling 3.3%.
Rezolute (RZLT) shares rose 2.3% after the company obtained US Food and Drug Administration clearance for an investigational new drug application for a phase 3 trial of RZ358 to treat hypoglycemia in people with tumor hyperinsulinism.
Actinium Pharmaceuticals (ATNM) shares plunged 60% after the US Food and Drug Administration determined that a phase 3 trial of Iomab-B to treat relapsed or refractory acute myeloid leukemia isn't adequate to support a biologics license application.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Sector Update: Health Care Stocks Fall Monday

Health care stocks were lower Monday afternoon, with the NYSE Health Care Index falling 2.2% and the Health Care Select Sector SPDR Fund (XLV) dropping 2.5%.
The iShares Biotechnology ETF (IBB) fell 2.8%.
In corporate news, Moderna (MRNA) is facing "material headwinds" for its vaccines for respiratory syncytial virus and COVID, RBC Capital Markets said in a report. RBC downgraded Moderna to sector perform from outperform and cut its price target to $90 from $125. Moderna shares were falling almost 3%.
Rezolute (RZLT) shares rose 1% after the company said it has obtained US Food and Drug Administration clearance for an investigational new drug application for a phase 3 trial of RZ358 to treat hypoglycemia in people with tumor hyperinsulinism.
Actinium Pharmaceuticals (ATNM) shares plunged 66% after the US Food and Drug Administration determined that a phase 3 trial of Iomab-B to treat relapsed or refractory acute myeloid leukemia isn't adequate to support a biologics license application. The firm said the FDA needs additional head-to-head trial demonstrating overall survival benefit with Iomab-B to support a BLA filing.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Sector Update: Health Care Stocks Fall in Afternoon Trading

(RTTNews) - Actinium Pharmaceuticals (ATNM) issued a regulatory update on the planned Biologics License Application filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. The company has concluded both clinical and Chemistry, Manufacturing and Controls interactions with the FDA regarding the BLA pathway for Iomab-B. The FDA has now determined that the analyses from the SIERRA trial do not adequately support a BLA filing for Iomab-B. The FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing.
The FDA has advised Actinium to conduct a study to evaluate allogeneic bone marrow transplant using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI, a difference from the SIERRA trial. Also, the proposed additional trial will not allow crossover, which was allowed in SIERRA.
Shares of Actinium Pharmaceuticals are down 64% in pre-market trade on Monday.
For More Such Health News, visit rttnews.com.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Why Is Actinium Pharmaceuticals Stock Falling In Pre-market?

(RTTNews) - Actinium Pharmaceuticals, Inc. (ATNM), a developer of targeted radiotherapies, reported Monday new analyses from the positive Phase 3 SIERRA trial of Iomab-B, showing that it markedly increased long term survival in patients 65 years or older with active relapsed or refractory acute myeloid leukemia or r/r AML.
In pre-market activity on the NYSE, Actinium shares were gaining around 2 percent to trade at $7.
The analyses were reported in oral presentations at the 2024 Tandem Meetings | Transplantation & Cellular Therapy (TCT) Meetings of ASTCT (American Society for Transplantation and Cellular Therapy and CIBMTR (Center for International Blood and Marrow Transplant Research).
The company noted that the presentations reported unprecedented 100% access to potentially curative bone marrow transplant or BMT and engraftment in evaluable patients with active r/r AML and improved long-term survival outcomes greater than 2 years in patients age 65 or older.
Active relapsed or refractory AML patients 65+ years receiving an Iomab-B led BMT achieved significant improvement in survival at one and two years compared to control arm patients none of whom survived even one year, the company noted.
Actinium said the SIERRA results presented at TCT demonstrate Iomab-B's ability to overcome multiple high-risk features including a TP53 genetic mutation, advanced age and treatment resistant disease.
Sandesh Seth, Actinium's Chairman and CEO, said, "SIERRA was a first of its kind trial to use targeted radiotherapy conditioning to enable potentially curative BMT in patients who are not typically considered for transplant in current practice. Importantly, SIERRA demonstrated superior outcomes with an Iomab-B led BMT to current standard of care in the control arm that included approved therapies targeting FLT3 and IDH mutations and venetoclax, a BCL-2 inhibitor. We are incredibly excited that Iomab-B led BMT improved outcomes across all major patient segments including patients with advanced age and comorbidities, treatment resistant disease and high-risk features including TP53 mutations, which are mostly associated with dismal outcomes."
For More Such Health News, visit rttnews.com
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Actinium: Iomab-B Increases Long Term Survival In 65 Years Or Older AML Patients In Phase 3 Trial

Fintel reports that on October 3, 2023, B. Riley Securities reiterated coverage of Actinium Pharmaceuticals (AMEX:ATNM) with a Buy recommendation.
Analyst Price Forecast Suggests 471.93% Upside
As of August 31, 2023, the average one-year price target for Actinium Pharmaceuticals is 32.03. The forecasts range from a low of 20.20 to a high of $55.65. The average price target represents an increase of 471.93% from its latest reported closing price of 5.60.
See our leaderboard of companies with the largest price target upside.
The projected annual revenue for Actinium Pharmaceuticals is 3MM, an increase of 5,702.22%. The projected annual non-GAAP EPS is -1.71.
What is the Fund Sentiment?
There are 157 funds or institutions reporting positions in Actinium Pharmaceuticals. This is an increase of 61 owner(s) or 63.54% in the last quarter. Average portfolio weight of all funds dedicated to ATNM is 0.01%, a decrease of 52.55%. Total shares owned by institutions increased in the last three months by 32.44% to 6,490K shares. The put/call ratio of ATNM is 0.12, indicating a bullish outlook.
What are Other Shareholders Doing?
VTSMX - Vanguard Total Stock Market Index Fund Investor Shares holds 794K shares representing 2.94% ownership of the company. In it's prior filing, the firm reported owning 876K shares, representing a decrease of 10.30%. The firm decreased its portfolio allocation in ATNM by 34.32% over the last quarter.
IWM - iShares Russell 2000 ETF holds 583K shares representing 2.16% ownership of the company.
Geode Capital Management holds 521K shares representing 1.93% ownership of the company. In it's prior filing, the firm reported owning 232K shares, representing an increase of 55.42%. The firm increased its portfolio allocation in ATNM by 59.38% over the last quarter.
VEXMX - Vanguard Extended Market Index Fund Investor Shares holds 357K shares representing 1.32% ownership of the company. In it's prior filing, the firm reported owning 361K shares, representing a decrease of 1.31%. The firm decreased its portfolio allocation in ATNM by 26.06% over the last quarter.
FSSNX - Fidelity Small Cap Index Fund holds 231K shares representing 0.85% ownership of the company.
Actinium Pharmaceuticals Background Information
(This description is provided by the company.)
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for its ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With its ARC approach, Actinium seeks to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Its lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, the company is developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include its CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning its clinical programs is its proprietary AWE (Antibody Warhead Enabling) technology platform. This is where its intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster its pipeline for strategic purposes. Its AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc.
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This story originally appeared on Fintel.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Actinium Pharmaceuticals, Inc. (Delaware)

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