timberwolf7
2 months ago
agree with you... What was the purpose for the question when it would be very easy to look thru their PR to see if one had been
issued.
But again, ya can't get one till an NDA review has commenced as far as I am aware of.
But on a side note, nice move developing in the share price and have to wonder if its in anticipation of the NDA submission pending..
disclaimer: hadn't bought any back yet because of a delay in things moving forward in CRMD (has been approved, expected to commence sales in April, but the market has not run it up as expected in anticipation of this occurring as it would normally be expected to happen: share price $3.33, 1st target price is $14-15 and I own shares. So yeah, its slow move has cost me a chance to flip some of those shares for ATNM which I had fully intended to do.. Dang nab it all)
timberwolf7
5 months ago
a lot of 'baby' bios are getting hacked up. CRMD for example just rec'd FDA approval of a compound that WILL become the standard of care because of its effectiveness. And despite the news, since the 'launch' isn't till (later?) in the 1st qtr 2024, its gone 'no where' on the news.
ATNM has gotten clocked, but what the heck, given a target price of $20+ (if they would stop selling frigging shares), its a 'gift' at these prices. But like CRMD, its going to have to EXECUTE (get approved and get sales going).
Got 1 other that has very good potential, but again, folks just don't seem to be interested in something that isn't 'doing'
I was just browsing thru their website, going over their Nov presentation. Was looking for an update on the BLA filing, see someone posted its now into the 1H 2024. Was going to start accumulating, but a look at the chart is indicating $4 may not hold now. So going to continue to be patient. Cause I suspect given the early stages for the rest of their effort (and years to an endpoint), the only thing that might turn this around would be news of the filing. And with that pushed back? LIke CRMD, the market is not being kind to baby bios. Course the other thing is, when the market turns from 'no price is too high' to lets get 'real''? Whats a 'fair value' takes on a whole different perspective. (example: Sava back when it was completing a PH 2 hit over $120/sh look at where its at now..and I would argue its still overvalued given what they have PROVEN)
Disclaimer: still being patient to buy back in.. And getting it down here just increases the potential reward if they can get approved)
oldstocks
6 months ago
Actinium Pharmaceuticals announced that it will be attending Bio-Europe, the
largest biopharmaceutical industry partnering event in Europe, taking place November 6 -- 8, 2023 in Munich, Germany.
Members of Actinium's senior leadership team will be available for one-on-one meetings during the in-person meeting as
well as the digital partnering taking place November 14-15, 2023. To request a meeting with Actinium through
partneringONE(R) https://informaconnect.com/bioeurope/. Interested parties may also contact the Company directly to
schedule in person or virtual meetings by emailing Actinium.
oldstocks
6 months ago
Actinium Announces Oral Presentation at ASH Annual Meeting Highlighting Iomab-B Treatment Significantly Increased Median Overall Survival in Relapsed or Refractory AML Patients with Highly Unfavorable TP53 Gene Mutation in the Phase 3 SIERRA Trial
November 02 2023 - 09:05AM
PR Newswire (US)
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- Relapsed or refractory AML patients with a TP53 mutation receiving Iomab-B led allogeneic bone marrow transplant had a median Overall Survival of 5.49 months compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002)
- Iomab-B's mutation-agnostic mechanism overcomes TP53 mutations and produced similar median Overall Survival outcomes of 6.37 months in TP53 negative patients and 5.72 months in TP53 positive patients
- Twenty-four percent of patients enrolled on SIERRA had a TP53 mutation that is typically associated with worse outcomes
- Oral presentation scheduled for Sunday, December 10, 2023, with two additional poster presentations detailing SIERRA trial results accepted for presentation
- Actinium reports third quarter financial results and provides a business update
NEW YORK, Nov. 2, 2023 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65th Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in the abstract include the following:
(PRNewsfoto/Actinium Pharmaceuticals, Inc.)
Median Overall Survival (OS) of TP53 positive patients receiving Iomab-B and a bone marrow transplant (BMT) was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B
Iomab-B produced a statistically significant improvement in median OS in TP53 positive patients with a hazard ratio of 0.23 and p-value of 0.0002
Median OS of 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations
24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm
Dr. Avinash Desai, Actinium's Chief Medical Officer, commented, "We are very excited by these results which show a statistically significant and greater than three-times increase in median OS in TP53 positive patients receiving Iomab-B. These results further support Iomab-B's differentiated profile and ability to improve outcomes for the most difficult to treat r/r AML patients. A TP53 gene mutation is arguably the most unfavorable risk factor leading to the worst patient outcomes as it is associated with inherent resistance to available therapies, short duration of responses and the lowest survival rates. Despite being a common mutation found in approximately 10-15% of all AML cases and up to 25% of patients over age 60, there are no approved therapies that target TP53. For patients with high-risk AML, particularly those with r/r disease and a TP53 mutation, BMT is associated with the best treatment outcomes and is the only potentially curative therapeutic option. Iomab-B's ability to facilitate a BMT in this patient population continues to demonstrate a strong clinical benefit as supported by these results and we look forward to presenting the full TP53 analysis at ASH in early December."
Detailed results will be presented in an oral presentation on December 10, 2023, as follows:
Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Novel Conditioning Regimens for Myeloid Malignancies
Session Date: Sunday, December 10, 2023
Session Time: 9:30 AM - 11:00 AM Pacific Time
Presentation Time: 9:30 AM
Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19
Publication Number: 469
Title: 131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML
Submission ID: 182177
oldstocks
6 months ago
Iomab-B is a new type of treatment for patients with relapsed or refractory acute myeloid leukemia (r/r AML), a type of blood cancer that is difficult to treat and has a poor prognosis.
Iomab-B is a targeted radiotherapy that uses a monoclonal antibody to deliver radiation directly to the bone marrow and spleen, where most of the leukemia cells are located.
This way, Iomab-B can destroy the cancer cells and prepare the patient for a bone marrow transplant (BMT), which is a potentially curative procedure.
Iomab-B has been tested in a large clinical trial called SIERRA, which showed positive results for patients who received Iomab-B and BMT compared to those who received conventional chemotherapy and BMT.
Some of the key findings from the SIERRA trial are:
• All patients who received Iomab-B were able to access BMT, while only 17% of patients who received chemotherapy were able to do so1.
• Patients who received Iomab-B had a higher rate of remission after BMT than those who received chemotherapy (75% vs 6.3%)1.
• Patients who received Iomab-B had a longer median overall survival than those who received chemotherapy (6.37 months vs 1.66 months)2.
• Patients who had a TP53 gene mutation, which is associated with worse outcomes in AML, had a similar median overall survival as those who did not have the mutation when they received Iomab-B (5.72 months vs 6.37 months)2.
• Iomab-B was well tolerated and had manageable side effects1.
Iomab-B is a promising new therapy for r/r AML patients who need a BMT but cannot achieve remission with conventional chemotherapy.
It is currently under review by the FDA for approval3.
If you want to learn more about Iomab-B, you can visit the official website of the SIERRA trial4 or the website of Actinium Pharmaceuticals, the company that developed Iomab-B1.
oldstocks
7 months ago
Found this on stocktwits
https://stocktwits.com/resume777/message/544196854
For those wondering what’s going on behind the scenes. Iomab-B, $ATNM lead PHIII complete cancer treatment, is being presented to the Department of Health & Human Services Centers for Medicare & Medicaid Services on September 12, 2023 for the determination of Iomab-B ICD-10 codes. Used for medical claim reporting in all healthcare settings, ICD-10 codes are the primary means to establish medical necessity for payment of healthcare services and procedures.
April 2024 implementation.
It doesn’t look like they are covering these NTAPS on the zoom
https://www.cms.gov/medicare/coding/icd10/c-and-m-meeting-materials/2023-09-12-icd10-meeting-materials
DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244-1850 CENTER FOR MEDICARE ICD-10 Coordination and Maintenance Committee Meeting ICD-10-PCS Therapeutic Agent Topics Consistent with the requirements of section 1886(d)(5)(K)(iii) of the Social Security Act, applicants submitted requests to create a unique procedure code to describe the administration of a therapeutic agent, such as the option to create a new code in Section X within the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS). CMS is soliciting public comments on the proposed coding options and any clinical questions for two procedure code topics associated with new technology add-on payment (NTAP)-related ICD-10- PCS procedure code requests that involve the administration of a therapeutic agent. The deadline to submit comments for these topics being considered for an April 1, 2024 implementation is October 13, 2023. Members of the public should send any questions or comments to the CMS mailbox at: ICDProcedureCodeRequest@cms.hhs.gov. Prior to the meeting, CMS will post a question and answer document on our website at https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials to address clinical or coding questions that members of the public have submitted related to the two therapeutic agents, as discussed in the following pages. At a later date, CMS will post an updated question and answer document to address any additional clinical or coding questions that members of the public may have submitted by the October 13, 2023 deadline. CMS will not be presenting the NTAP-related ICD-10-PCS procedure code requests that involve the administration of a therapeutic agent at the September 12, 2023 virtual meeting. CMS will present the NTAP-related ICD-10-PCS procedure code requests that do not involve the administration of a therapeutic agent and all non-NTAP-related procedure code requests during the virtual meeting on September 12, 2023. Comments on all procedure code proposals should be sent to the following email address: ICDProcedureCodeRequest@cms.hhs.gov.
Looking for info on the above I got this from ai chat
I’m sorry, but I couldn’t find any specific information about the presentation of Iomab-B’s Phase III complete cancer treatment to the Department of Health & Human Services Centers for Medicare & Medicaid Services on September 12, 2023, for the determination of Iomab-B ICD-10 codes. However, I can share that Iomab-B is a first-in-class targeted radiotherapy developed by Actinium Pharmaceuticals1. It has shown positive results in the pivotal Phase 3 SIERRA Trial for patients with active relapsed or refractory Acute Myeloid Leukemia32. The trial met its primary endpoint of durable complete remission of 6-months following initial complete remission after Hematopoietic Cell Transplantation (HCT) with a p-value of
timberwolf7
8 months ago
Been a while, but have been monitoring the share price trend. Also tracking the FLOAT, hope they can keep it sub 30 Mil shares (26 Mil) so that the darn 'target price' doesn't get hit like it has for one I am heavily in at the moment (delays in their approval timeline has forced ATM dilution).
And know this won't be a likeable comment, but if it can hold sub $8 into the end of the year?? With a target price of around $25-30?? Be a happy buyer for the run into their approval decision (question is, are they still on track for an NDA submission late this year??)
disclaimer: currently own none, but am bullish especially as the price has slid lower