timberwolf7
2 weeks ago
I have followed ATNMs lead development for years. Fortunate to not be loaded up like I once was
when the fda screwed them over with their denial of their approval efforts. Thats going to set them
back a couple of years to get another trial composed, initiated, ran and data scrubbed. Not to mention
bleed them of the cash they have.
Couple that with where their other developments are in their pipeline? ATNM is either going to need a
partner (which has already been mentioned) or is going to be selling a lot of shares to raise cash in order
to fund their developments.
And again, they are looking at 2 years or so before they will be able to bring their first
development back to the fda.
This had so much promise.. Now?? One has to ponder the question of, did some
big pharma decide they want to be able to buy ATNM for pennies on the dollar?? For their
cancer related developments?? And the best way to do it was to delay a revenue stream
from occurring. (yeah, I know this sounds a little over the edge, but have seen enough to
no longer discount things like this when 'money' is involved)
Monroe1
2 months ago
Actinium Pharmaceuticals Appoints Accomplished Biopharma Industry Executive June Almenoff, M.D., Ph.D. to its Board of Directors
November 04 2024 - 7:30AM
PR Newswire (US)
Alert
Print
Tweet Share On Facebook
- Dr. Almenoff brings more than 25 years of drug development and leadership
experience to the Actinium Board of Directors
- Dr. Almenoff to join Actinium's Nominating and Corporate Governance Committee
NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, today announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to numerous biopharma companies.
(PRNewsfoto/Actinium Pharmaceuticals, Inc.)
Andes Seth, Actinium's Chairman and CEO, stated, "Through her career, June has amassed significant experience in translational research, drug development and business development that has resulted in multiple approved products and value creation. Her experience will be invaluable to Actinium and we are delighted to add Dr. Almenoff to the Actinium Board."
Dr. Almenoff served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie) for $1.2B. Furiex developed eluxadoline (Viberzi®), which was approved both in the United States and Europe. She also served as Chief Medical Officer of RedHill Biopharma Ltd (Nasdaq: RDHL) leading a team whose work led to the recognition of Talicia® as a first-line therapy for H. pylori. Earlier in her career, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. She also led the development of pioneering data analytics systems, which have been widely adopted by industry and regulators to minimize clinical risk for pharmaceutical products.
Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development across many therapeutic areas, and has led or contributed to numerous regulatory submissions, product approvals and launches. She is a member of the investment advisory board of the Harrington Discovery Institute, a director on the board of Avalo Therapeutics, Inc. (Nasdaq: AVTX) and Tenax Therapeutics (Nasdaq: TENX).
Dr. Almenoff added, "Targeted radiotherapy has become an important treatment option for patients in multiple oncology indications, which I believe will only continue to expand. I am impressed by Actinium's innovative R&D, clinical development experience and capabilities, as well as its proprietary Actinium-225 manufacturing technology. Collectively, Actinium has the vision and components to become a leading fully integrated specialty radiopharmaceutical company. I am excited to join the Actinium Board and look forward to working to help the company realize its vision and create value for patients and shareholders alike."
Dr. Almenoff received her B.A. cum laude from Smith College and graduated with Alpha Omega Alpha honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored over 70 publications.
About Actinium Pharmaceuticals, Inc.
Actinium develops Antibody Radiation Conjugates ("ARCs") and other targeted radiotherapies intended to meaningfully improve outcomes for people who have failed existing oncology therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with relapsed and refractory acute myeloid leukemia ("r/r AML"), which Actinium is seeking a potential strategic partner for in the U.S. The company continues to advance its development for product candidate Actimab-A, a therapeutic agent that has demonstrated potential activity in r/r AML patients. In addition, Actinium is engaged with the National Cancer Institute ("NCI") under the Cooperative Research and Development Agreement ("CRADA") for development of Actimab-A in AML and other myeloid malignancies. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds more than 235 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.
For more information, please visit: https://www.actiniumpharma.com/
timberwolf7
2 months ago
Yeah, but unfortunately, its going to take a good 2 years to get this 'additional trial' done.
Time line includes developing the trial, getting the fdas concurrence that it will meet their 'standards' (until it doesn't)
set up the trial sites, run it and then data scrub.
Then add on another 2 months to get the fDA to accept the NDA, 6-9 months to get a decision.
Hell, ATNM is looking at damn near 3 years before they could get a decision.
And then there is the question, how many shares are they going to have to sell to stay solvent..
Ie, there goes the $20+ target price.
What a frigging mess.
timberwolf7
3 months ago
On ICU... only 4 or so Mil shares, thats nice to see (course they did a r/split to get there)
Bigger issue may be the SMALL population of potential patients in terms of who THEY see
as their potential 'market'..
Interesting 'development', something I am familiar with in terms of it basically being a
blood 'conditioner'. Got to look into how well it really works from the aspect of, if someone
gets this 'condition', will the facility see their development as something they HAVE to try.
On NSPR, I don't own any yet. Still watching the momentum which is weighing negative,
but the share price is resisting breaking down, holding $2.7. Was hoping it would drop to $2.50
or less...But will be getting some before their next earnings call just in case they say something along
the lines of revenues/sales in the overseas markets continues to move higher..
timberwolf7
3 months ago
Oops, wrong company.. Meant AWE platform for attacking solid tumors...
If you are looking at something to get into, check out NSPR.. They have just submitted an application for approval for a
stent design that IS a lot better than the current technology being used. They are anticipating a decision in the 1st half of 2025.
I have traded the shares a couple of times in the past, have a 'very conservative' initial target price of $5. Which from the current
price of around $2.75, would be around a 80% POTENTIAL return IF the fda approves their medical DEVICE (not a drug). Which
is already approved overseas and is being sold/used. (but no secret, you want to generate serious revenues, you need to be approved
to sell into the US market).
Disclaimer: I don't own any at the moment, just watching to see if the share price will keep slipping off its recent highs from the news
that they submitted their application.
NOTE; will check into ICU, but from an initial quick look at what they are doing, I prefer to find companies that are doing something much better
than whats already on the market, or something NEW... AKA, ATNMs conditioner effort and still can't believe what happened to them.
https://www.actiniumpharma.com/awe-technology
Actinium's Antibody Warhead Enabling (AWE) Technology Platform
Actinium's AWE technology platform is used to produce ARCs or Antibody Radiation Conjugates, a highly potent and selective form of targeted radiotherapy. ARCs enable the precision targeting of the proven therapeutic power of radiation to tumors and its synergistic potential with other therapeutic modalities that cannot be matched by traditional external beam radiation, cytotoxic chemotherapy or biologic therapies. AWE enabled ARCs exploit the use of highly selective targeted biological agents such as monoclonal antibodies that can seek out and bind cancer antigens found on the tumor cell surface to deliver potent radioisotopes that are capable of producing double strand DNA breaks for which there is no known resistance or repair mechanisms.
timberwolf7
4 months ago
Yeah, I sold out some years ago as well, held off taking a new position until recently.
Got a 1000 shares at $7.55, have $900 in profits off the covered calls. So going to keep doing that
while this gets figured out. Only concern is whats going to happen to the value of the calls as this
quiets down.. Might be tough to get a lot for them.
Yep, have seen enough out of the fda to again, realize its integrity has been compromised.. And that
IS NOT a good thing..
But sadly, its just a reflection of the overall breakdown in morals, ethics, integrity, honesty in this world now.
Replaced by the desire for GREED and POWER no matter what gets sacrificed to get it.
timberwolf7
4 months ago
Yep, thats my understanding as well. They concurred in the trial, which means they
had agreed on the 'acceptance' criteria.
But at least this explains WHY its taken them so long to announce filing for approval.
And been a long time observer/concluder that the FDA doesn't have the publics best
interest as their primary goal. Figured it out some years ago that big pharma runs the
fda, guides its 'decisions'.
Even to the point where I have suspected that new ideas trying that are 'targets' by
a big pharma who would like to own the idea, may find it harder to get to their end point.
To the point they become illiquid and forced to 'negotiate' just so that the developers can
get something for their efforts.
Or even worse, in this case, since this does appear to HELP people going thru treatment,
that despite this conclusion, the fda doesn't give a damn that it does. And once again, instead
of saying, we will approve but you have to do a PH 4 followup to conclude just how well it works.
We are going to flat out DENY the ones that could benefit from this from using it to help extend/save
their lives. Nope, we are going to endanger lives instead by DENYING them a potential treatment
that has shown it can help them. That to me is the really sick part of this mess.
Yep, sure appears to be a royal screw job. Not just for ATNM, but really for those that it could HELP.