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Sorry, not sure what you’re asking. Actinium as a radioactive atom doesn’t exist naturally and is extremely rare. That being said, the company, Actinium pharmaceuticals, uses radioactive elements combined with human antibodies to fight blood cancers.
How valuable is raw ACTINIUM I have #11 pounds?~~~~from one of my gold mines in ALASKA.
There are signals in the stock today. The Actinium Pharmaceuticals, Inc stock holds signals where the long-term average is above the short-term average. On corrections up, there will be some resistance from the lines at $7.07 and $7.48. A break-up above any of these levels will issue buy signals. A buy signal was issued from a pivot bottom point on Thursday, July 27, 2023, and so far it has risen 0.579%. Further rise is indicated until a new top pivot has been found. Furthermore, there is a buy signal from the 3 month Moving Average Convergence Divergence (MACD). Volume is rising along with the price.
This is considered to be a good technical signal.
NEW YORK, July 24, 2023 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that the Company will participate in the 2nd Annual Targeted Radiopharmaceuticals Summit in Boston, July 25 - 27, 2023. Actinium will present "Targeted Radiotherapeutics & Innovative Combinations to Alter the Treatment Outcome for Conditioning, Hematological & Solid Tumor Malignancies" on Thursday, July 27, 2023 at 12:30pm ET.
After my sale last year, I’ve determined that my time horizon for this stock is a lot longer and also depends on how much the price will increase after an FDA approval.
Actinium Pharmaceuticals ATNM Stock Price Target $33.25
52 Week high $15.12
The Short interest report
Last report 6/30/2023
2,140,000 shares
8.7 Dayd to Cover
Forecast is for Shorts to Cover
Actinium Pharmaceuticals Inc Stock Price Forecast for 2023
August 2023 7.289 8.189 7.289 8.21310.99 % ?
September 2023 8.162 8.852 8.162 8.8637.8 % ?
October 2023 8.892 9.328 8.833 9.3284.68 % ?
November 2023 9.351 9.244 9.244 9.466-1.16 %?
December 2023 9.221 9.193 9.193 9.325-0.3 %?
Actinium Pharmaceuticals Inc Stock Price Forecast for 2024
January 2024 9.177 9.179 9.026 9.1880.01 % ?
February 2024 9.180 8.862 8.862 9.251-3.59 %?
March 2024 8.828 9.701 8.828 9.7048.99 % ?
April 2024 9.768 9.714 9.710 9.829-0.55 %?
May 2024 9.688 9.761 9.446 9.7660.75 % ?
June 2024 9.820 9.209 9.209 9.847-6.63 %?
July 2024 9.213 9.349 9.201 9.3491.46 % ?
August 2024 9.369 10.239 9.369 10.2908.5 % ?
September 2024 10.254 10.962 10.254 10.9626.45 % ?
October 2024 10.989 11.406 10.907 11.4063.66 % ?
November 2024 11.409 11.293 11.293 11.532-1.02 %?
December 2024 11.321 11.278 11.267 11.404-0.38 %?
Actinium Pharmaceuticals Inc Stock Price Forecast for 2025
January 2025 11.259 11.226 11.099 11.259-0.29 %?
February 2025 11.283 10.915 10.915 11.319-3.38 %?
March 2025 10.917 11.825 10.917 11.8257.68 % ?
April 2025 11.862 11.787 11.787 11.903-0.64 %?
May 2025 11.756 11.810 11.512 11.8120.46 % ?
June 2025 11.882 11.291 11.291 11.915-5.24 %?
July 2025 11.311 11.404 11.270 11.4040.82 % ?
August 2025 11.410 12.318 11.410 12.3647.37 % ?
September 2025 12.329 13.057 12.320 13.0575.58 % ?
October 2025 13.056 13.449 12.985 13.4492.92 % ?
November 2025 13.544 13.369 13.369 13.613-1.31 %?
December 2025 13.391 13.349 13.349 13.480-0.31 %?
Actinium Pharmaceuticals Inc Stock Price Forecast for 2026
January 2026 13.325 13.284 13.174 13.325-0.31 %?
February 2026 13.343 13.007 13.007 13.403-2.59 %?
March 2026 12.994 13.919 12.993 13.9196.64 % ?
April 2026 13.927 13.854 13.854 13.978-0.53 %?
May 2026 13.810 13.855 13.584 13.8550.33 % ?
June 2026 13.939 13.389 13.373 13.981-4.1 %?
July 2026 13.379 13.446 13.341 13.4460.5 % ?
August 2026 13.569 14.407 13.569 14.4355.82 % ?
September 2026 14.427 15.124 14.386 15.1244.61 % ?
October 2026 15.117 15.485 15.065 15.4852.37 % ?
November 2026 15.590 15.462 15.447 15.694-0.83 %?
December 2026 15.487 15.414 15.414 15.555-0.47 %?
Actinium Pharmaceuticals Inc Stock Price Forecast for 2027
January 2027 15.377 15.341 15.251 15.377-0.24 %?
February 2027 15.402 15.104 15.104 15.482-1.97 %?
March 2027 15.078 15.983 15.053 15.9835.66 % ?
April 2027 15.986 15.908 15.908 16.052-0.49 %?
May 2027 15.869 15.990 15.661 15.9900.76 % ?
June 2027 16.032 15.459 15.459 16.052-3.71 %?
July 2027 15.442 15.489 15.415 15.4930.3 % ?
August 2027 15.596 16.505 15.596 16.5055.51 % ?
September 2027 16.496 17.184 16.457 17.1864.01 % ?
October 2027 17.166 17.518 17.140 17.5182.01 % ?
November 2027 17.632 17.559 17.528 17.771-0.41 %?
December 2027 17.554 17.467 17.467 17.628-0.5 %?
Actinium Pharmaceuticals Inc Stock Price Forecast for 2028
January 2028 17.451 17.459 17.330 17.4620.05 % ?
February 2028 17.496 17.178 17.168 17.556-1.85 %?
March 2028 17.162 18.032 17.121 18.0414.82 % ?
April 2028 18.083 18.003 18.003 18.126-0.45 %?
May 2028 17.969 18.095 17.744 18.0950.7 % ?
June 2028 18.100 17.493 17.493 18.139-3.47 %?
July 2028 17.511 17.523 17.507 17.5650.07 % ?
Congratulations on your treatment success! I also share your enthusiasm with ATNM but had substantially reduced my investment about a year ago. (Needed some cash). I still feel that what I have remaining will yield a solid return. Good luck with your continuing good health and your investments.
I am in ATNM Actinium Pharmaceuticals because it is a biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients.
I really do not care if i make or lose money on this stock.
I’d rather make money on my investment.
As a cancer survivor i would love to see more cancer companies with promising treatments.
ATNM will be back over the 52 week high.
Thanks to cancer treatments i will be hear to see another 52 week high.
My treatments were not a result of Actinium but radiation ?? treatment did kill my cancer.
ATNM broke over $14.50 twice in the last year.
The time to get in and hold while the price is low and hope for a run over $14 again.
I had hope and i keep that hope for ATNM
I added to my position Friday. I am in ATNM because i believe they can help people with cancer.
This is something you don’t think of until you have cancer yourself. Cancer treatments are not cheap.
Good thing for insurance.
Fact is Cancer sometimes can be beat.
Cancer will always be out there.
People will need cancer treatments.
Well time for me to get ready to drive to Orlando hospital for an injection, and again tomorrow for a pill to swallow and again Thursday for a scan to see if my treatment has worked.
My treatment is not related with any of ATNM trials or products. I just like what i see with ATNM
Not a pump and dump. Atnm has a great future
law of averages
Any reason for stock moving up today?
Street target price: Avg based on yahoos finance page is $31/sh...
Something to track although they say they have a lot of cash on hand (they should they doubled up the damn share count to 25 Million) is the 'share count' which as of the end of the 1st qtr 2023 is around 25 Million..
So from a timeline standpoint, end of this year for an NDA submission.. add 9 months to that..
If I had shares right now, I would be selling the covered calls for what I could get, at the $10 level. Just don't see a reason coming in the near future to jeopardize $10/sh..
disclaimer: still don't have any, loaded with CRMD which just got their timeline clarified, sitting at $5/sh, target price $15 on 41 Million shares outstanding. And if they get the additional sector (oncology) we know they will be asking approval for, well that puts the target price north around $25+.. Just going to take till the end of the year for an FDA decision from the looks of it.
Been watching the share price and have to say, its gotten 'attractive' again at sub $10/sh..
See that they intend to file their NDA later this year, so given the time after that for a decision (around 9 months after the NDA is accepted),
Guess I will be looking to take another 'round' with this one..
and agree, unless the fed death agency screws around with them, the data indicates is should be approvable.
disclaimer: own none, but will be looking to accumulate.. Good luck.. at least there is a timeline now..
Results were definitely FDA approvable. Everyone is probably just upset because no buy out was announced. Give it time, it’ll bounce back.
What's wrong? I don't understand! Down 5$ in two days! Why? Results are out and not so bad?
ATNM PR makes me think I missed something. For in the PR, they discuss their 'financial/expansion' activity in the EU..
and say the market share there MIGHT be bigger than what they have in the US.
IF this is accurate, my target price looks like its going to be 'way' low cause I didn't 'see' this coming.
And I hadn't heard anything about the EU mentioned before in terms of a revenue stream.
Be interesting to see what the analysts do with this info, what target price they start to 'update to' now.
Disclaimer: I own none, but one of my kids held onto their shares and is enjoying the run (we were selling calls for some time, so the cost basis is sub $10/sh)
nice run in progress. My son kept his shares so he is now up some on them.
Still have a $20/sh target price due to the higher share count. Hopefully for those holding,
when they start to talk about marketing, they get better numbers in terms of reimbursement rates.
Good luck to those holding. Note, I am still following their other programs in progress, but they have
a ways to go..
Note, son will likely take what it gives and move the gains into shares of CRMD if that still hasn't gotten
the clearance from the fda to move towards its own approval.
Again, good luck
Just thought I would drop this info on the board for those that may not have seen it.
Got a letter related to ATNM asking me to make sure I vote for the requested uptick in the number of shares
they want to make available for what appears to be 'compensation' packages. From 5 Mil to somewhere in the 8 Million range.
Thats an additional 3 Million shares on top of the more than doubling of the share count outstanding since they did the r/split down to
11 Million.
What a frigging disappointment... But as a side note, while I have unloaded my shares for another 'opportunity' (CRMD), I do intend to follow
ATNMs additional AWE related efforts cause those could be real share price boosters IF they are successful. But will be waiting for the PH 2 results before I consider buying any shares.
Good luck.
Damn.. in MY message that I am replying to, I made reference to a company in a PH 3 that is nearing the completion of enrollment. I said NGENF, but what it should have been was NSPR.
I did buy 'some' at $1.14 after I posted that prior one, plan to keep slowly building a position in it, but it has a ways to go before the PH 3 is completed. Thanks to a 1 year 'monitoring' period post enrollment in the trial. Not too thrilled to see the share price moving up, but why I started nibbling was I expect the PH 3 to go as well as the PH 2 did (not a 'complex' development in terms of whether it will 'work' or 'not', cause the PH 3 is essentially an extension of the PH 2)
On a follow up, AVXL did release data from their Ph 2/3 EARLY stage ALZ trial. While the data 'sounds' positive, and the market 'somewhat' liked it (nice pop in the share price), they do need to clarify what they said in terms the market can 'understand' without questioning. And they did surprise late Friday with a release saying they will hold another CC on Monday pre market. So that could get interesting.
(disclaimer: only own 500 shares of AVXL at a cost basis of $8.75/sh) (intention was once the market absorbed the end of the PH 2/3 trial news, planning to keep selling covered calls once the share price settles down. And buy calls for the decision day once the NDA was accepted for review) IF I like the odds of approval. Tho have no idea how to 'put' a value on the shares till they do with what they say.
So reason for posting this was because of the clarification on NSPR and the follow up on AVXL. And note, thought I had all of my ATNM shares taken away at $7.5, but do have 2000 in an account that I had sold $12.5s (Jan expiration) against instead of the Nov $7.5s Will make a decision on whether to hold them come Jan vs keep selling covered calls in a 'take what it gives' mode. But at present, not buying any new ones.
Definitely agree that some of the shine is off the apple. I paired down my position (sold about 1/3 shares) last week for about a 40 percent profit- would have loved to sell more, but that’s all that was ripe for the picking. Now I wishfully hold on for approval or partnership/buyout! Happy Thanksgiving to all and good luck!
OK, gave up my shares to the covered calls.
And now due to the increase in outstanding shares? As mentioned, no longer as 'enamored' with ATNM as I was in terms of a re-entry price. So, rolled the proceeds into more CRMD shares (target price currently at $20 (mine), $25 by some analysts) this morn at $3.95.
Also took a flier on some AVXL shares at $11.58, and then sold the Dec 2 $12 covered calls for $3/sh. They have an 'event' on the 30th of Nov, to present some data, also rumor has it that on 1 Dec, there could be an update on their PH 3 trial which is nearing completion (a roll of the dice cause their PH 2 did not give me enough to say it 'can' help Alzheimer patients with 'confidence' enough to throw a lot of money into it. So went this route and will likely lose the shares or, if the price holds, as the time premium drops, may close them out and sell another round. Will see.
But one last comment, check out NGENF. They are in a PH 3, only 8.3 Mil shares outstanding, but an Israeli company. They are supposed to complete enrolling their last trial participant by the end of the 1st qtr 2023. Then a year follow up. I don't own any at the moment, but plan to start accumulating after they announce the last enrollment occurred. Target price conservatively, $4-5, suspect higher, but start low and see how the numbers shake out later. So a buy at less than $1.50 could be a decent return.
Good luck. and damn them for doubling up the share count and its impact on the potential return.
But imagine if you were one of the ones 'chasing and buying' when it ran up, especially the one(s) that paid up around the peak price.
So True. I was just venting. Just hating the process/ bad timing I guess.
It will see the target price IF its approved and sales commence. Thats when the market will start to price in its potential. Can't expect it to happen now in this market environment, especially when its a non-exciting development with limited 'revenue' potential. (ie, its not an alzheimer or cancer drug for example)..
So between now and say the next 3 months, sell covered calls, get what you can for them to reduce your cost basis while you wait.
In the meantime, check out CRMD. Its a gift at $3, target price on it ranges from $20-25 on initial approval. IF they didn't run into quality issues at the manufacturers they chose to use to produce the compound, they would be $20 already, but it delayed their approval. And on top of it, this target price is based on less than 1/2 of its potential market. I know the company is already working on how to get approved for its potential total market, and the target price for that is north of $35-40/sh..
as a disclaimer: I am loaded up on CRMD shares, and just added some down here at $3 the other day. But they are looking at up to another 6-8 months for another go at the fed DEATH agency for consideration (death agency after how they 'approved' the use of the pfizer jab solution that has been hurting and killing folks, and yet the fdeath agency won't pull it from being used)
Got to acknowledge, its NOT the company's fault that there is a process for getting approved that includes time to generate the NDA and then the FDA review (6-9 months).
So I wouldn't be bashing the company at all for whats happening to the share price cause until its approved, the drug is NOT worth anything.
And its the reason why I mentioned I doubted this would see much higher before it pulls back, why some profit taking (especially if you have an account that doesn't tax you for your trades/gains now (gets you when you start withdrawing from them instead). Or consider selling covered calls to get 'something' when it peaked.
Now for me, I am not surprised to see it pullback, especially in a weak market like this. But at the same time, not surprised it ran as strongly as it did in a weak market desperate for something to buy (momentum traders). So now we will see where it bottoms out at, and I won't be surprised to see it sub $10. Just the way the market works. But imagine if you were one of the ones 'chasing and buying' when it ran up, especially the one(s) that paid up around the peak price.
(Also a novice posting). I’m just posting on my frustration on holding an equity, believing in that equity’s science and even adding to my position over the past (let’s say) 6 years. During that time, watching a reverse split and significant dilution reduce my expectations to about $20/sh. after their “big news”. My understanding is that, in developing biotechs, the greatest increases come shortly following presentation of statistically significant results. Their SIERRA phase 3 results reveal an approvable winner. I’m venting on the lackluster response from the market. That’s not to say it still won’t happen but my expectations have, yet again, been tempered. Such is life with investing in developmental biotechs.
I'm a novice (at best) in this, but isn't it healthy for the stock to consolidate at these keveks? The RSI on the daily was over 90 before yesterday and now it's back in the low 70's.
I hate to turn into that guy who goes and bashes a company that I am currently invested in, but days like today leave me little to be happy about. Your original post regarding being at the mercy of a lousy market (dreading the next FOMC meeting etc) makes me believe I’ll need to hold this a great deal longer to hit the 20 mark. Seriously debating taking the minimum gain I have and finding greener pastures.
Got an email from ATNM this morn talking about the results of a PH 1 trial. Promising, but lets see, since its associated with dealing with cancer, that means they are looking at, at least 4 years to get to the end of a PH 3 trial??
With nothing else in the so called 'pipeline' beyond a PH 2? The market cap is likely to be limited to what this current development is 'worth'.
So waiting to see what they say with respect to the possible 'price/dose', anticipated annual 'doses' sold, et al.
Yet in the meantime, see the market is starting to trim off some of the 'fun' from the momentum chasers. ATNM held $11-12/sh shortly after they did that 1-30 R/split. Will it try to hold there again?? Or??
To be determined. And this is the tough part of being in a baby bio with its first development finishing a PH 3. Do ya dare to sell when it peaks on PR like this one is hinting might be happening? Hope to buy it 'cheaper' and get the same # of shares back after paying taxes on the gains just taken? Or do you hold and see what happens knowing that the odds favor getting out 'higher'..
Good luck.. disclaimer: been thru this decision before. its a damned if you did, damned if you didn't cause you never know till history has been 'written'..
Market valuation, it is what they think the market will eventually price it at. Even that is low based on the pipeline and enough funds to move this forward till next year without additional funding, but who knows, if the management doesn't pull out another hat trick.
doubt someone will buy them out for the current development.
Now if they start to see 'success' with their other product lines, I could see a buy out happening, but they are still years away from getting that kind of 'confirmation' that the developments 'really' do work.
My plan was to hold onto some shares, take gains on the rest, and only hold them IF i could get decent covered call 'returns' on a frequent basis. Otherwise, sell them all and try something else while I waited and watched.
I had $30 (minimum) as a price target BEFORE they went and doubled the damn share count + some (from 11 Mil shares to 25 Million)
Now have $20 and thats based on a projection someone threw out a year or so ago for a market cap of $600 Mil and I had no idea where they pulled that out of at the time it came out (ie, what was the 'basis' for this 'estimate')
Thats the price it would achieve on approval and peak sales...
bit early for that to happen with the long slog to 'approval' now about to commence
Hey, capping my gains is not a bad problem to have (course, I am saying it to mitigate the 'gains' I am likely to not get (smile))..
But its another 9 months to go.. On that note, this market action is also somewhat confirming what I was wondering if we would see.
That in a market desperate for any reason for shares to run higher, that if that reason occurred, would it happen. So for this one (course, the tight share count really helps), yes it happened.
Now the question is, how far will it fall when the euphoria caps, and how fast does it happen. My son was slow to sell covered calls, and that worked out for him cause he sold the Dec 15s with the share price in the $13.5 range. Was half tempted to tell him to sell his shares instead and reload IF they dropped, cause I suspect that once the selling starts, again, given the low share count? Could get interesting.
But yep, goofed up on this one (so far).. but again, if I lose them, at least it will be with gains..
Now to see what the 'analysts' and company says with respect to expected revenue generation. Cause this product is looking like a 'one dose' and done sale. So they better be able to get a decent price or that estimated $600 Mil market cap might be tough to achieve on just this one product.
Good luck
Cheers - I'd take a buyout. Would actually appreciate someone taking the decision of when to exit out of my hands
My price target still stands at $20 short term, within this week or end of next week the latest. Anything can happen after that, the company is primed for a buyout and it could range from 30-50 dollars.
You say 70% accurate as to your price targets and also that 20-25 will definitely happen before year end. So what's your price target?
You will surely see those number most definitely by year end.
I’ll settle for 20-25 by year end
Maybe it will, maybe it won't. Will this be one of those that I batted 100%? Who knows, but I do know one thing, I am 70% accurate with my price targets.
20 late this week or early next week.
Actinium shares are trading higher after the company announced the results from its pivotal Phase 3 SIERRA trial of iomab-b in patients with active relapsed or refractory acute myeloid leukemia met its primary endpoint of durable complete remission.
I’m sorry it didn’t pan out for you. I would’ve been happy to wait another month or so (what’s a few months after several years anyway). You had history on your side with this one. The way I see it, although still positive, even the gains in pre market trading have been falling since I awoke..,
You don't think we'll see a run up leading to Ash?
Well now, if someone has an 'award' for lousy timing??
I win with my decision to sell covered calls on my shares 'recently' (ok, for $3/sh cheaper than they are now) (my take out price is actually around $8.50 due to what I got for the calls)
But now with the new being out?? Now starts the long next 3 months or so for the NDA submission(??), then another 6-9 for the review and decision...
See what it does after this news is 'absorbed'..
Way it goes sometimes.. Good luck to those that still 'own' theirs (smile)
Actinium Announces Positive Top-line Results from Pivotal Phase 3 SIERRA Trial of Iomab-B in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia
DOWNLOAD AS PDF OCTOBER 31, 2022
- Iomab-B met the primary endpoint of durable complete remission of 6-months following initial complete remission after HCT with a p-value of <0.0001
NEW YORK, Oct. 31, 2022 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B. The SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial was conducted in patients 55 years of age or older who had active disease (relapsed or refractory AML). The SIERRA trial is a randomized, multi-center, controlled study which compared Iomab-B as a conditioning regimen prior to a Bone Marrow Transplant (BMT) versus a control arm which allowed all current means of conventional care with the intent to transplant these patients. The SIERRA trial met its primary endpoint of durable complete remission or dCR of 6 months post initial remission after a BMT in Iomab-B arm compared to conventional care arm demonstrating statistical significance p<0.0001.
(PRNewsfoto/Actinium Pharmaceuticals, Inc.)
Dr. Avinash Desai, Actinium's Chief Medical Officer, added, "We are excited that the randomized, controlled, multi-center, pivotal SIERRA trial has delivered these results for patients that need new treatment options. Our goal is to increase access to BMT and improve patient outcomes with Iomab-B, and these topline results move us in this direction given their statistical significance. We will continue to work on our Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for approval of Iomab-B. On behalf of Actinium, I'd like to thank the patients who took the leap of faith and enrolled in the SIERRA trial, their families and caregivers who supported them and the investigators who contributed their efforts and advice who made this trial possible. Without them it would not have been possible to yield these results that will enable us to continue to develop Iomab-B."
Sandesh Seth, Actinium's Chairman and CEO, said, "This is a significant milestone in Actinium's lifecycle and a testimony to the quality of our team who undertook a pioneering study in a patient population that is considered largely futile to treat. Despite being perennially under-staffed and under resourced, their passion and perseverance has yielded a clinically meaningful dividend. Our recently strengthened team is executing to enable our mission to disrupt the field of bone marrow conditioning with Iomab-B, first in r/r AML and then by building upon its robust prior clinical results in several hematological diseases. We look forward to sharing additional clinical data from the SIERRA trial by year end."
About Iomab-B and the Pivotal Phase 3 SIERRA Trial
Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial produced positive topline results, meeting its primary endpoint of durable Complete Remission (dCR) of 6 months with statistical significance (p<0.0001). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037.
The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician's choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 single agents or combination of agents as no standard of care exists for this patient population. Data from full patient enrollment presented at the Transplantation & Cellular Therapy Tandem Meetings in April 2022 showed that 100% of patients receiving Iomab-B accessed BMT and engrafted without delay. Iomab-B was also shown to be well tolerated given its targeted nature, consistent with its previous clinical data. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs.
Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs. Actinium's clinical pipeline is led by radiotherapies that are being applied to targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a bone marrow transplant (BMT), gene therapy or adoptive cell therapy, such as CAR-T, to enable engraftment of these transplanted cells with minimal toxicities. Our lead product candidate, I-131 apamistamab (Iomab-B) has been studied in over four hundred patients in six disease indications including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), hodgkin's lymphoma, non-hodgkin's lymphoma (NHL) and multiple myeloma across twelve clinical trials including the pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. Iomab-B targets CD45, a cell surface protein expressed on blood cancer cells, normal nucleated immune cells and bone marrow stem cells. Actinium licensed the world-wide exclusive rights to Iomab-B from the Fred Hutchinson Cancer Research Center, a noble prize-winning institution that pioneered the field of bone marrow transplant. Data. Data from the pivotal Phase 3 SIERRA trial has been presented at multiple international medical conferences such as the annual meeting of the American Society of Hematology (ASH) with recent topline data submitted for presentation at this year's meeting, the Tandem Meetings, Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), and the annual meeting of the Society of Hematologic Oncology (SOHO), where it was awarded honorable distinction in 2019. Post successful topline results, the Company expects to release a more comprehensive set of results by year-end 2022 and is working toward a BLA filing in 2023. Iomab-ACT, low dose I-131 apamistamab, is being studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy with Memorial Sloan Kettering Cancer Center with NIH funding. Iomab-ACT employs a lower dose of I-131 and is being developed to be a single-infusion, out-patient administered therapy that can transiently lymphodeplete patients prior to receiving their CAR-T cellular therapy. Actimab-A, our second most advanced product candidate has been studied in approximately 150 patients with Acute Myeloid Leukemia or AML, including in ongoing combination trials with the chemotherapy regimen CLAG-M and with venetoclax, a targeted therapy. Actimab-A or lintuzumab-Ac225 is an Actinium-225 based antibody radiation conjugate targeting CD33, a validated target in AML. Actinium is a pioneer and leader in the field of Actinium-225 alpha therapies with an industry leading technology platform comprising over 195 patents and patent applications including methods of producing the radioisotope AC-225. Our technology and expertise have enabled collaborative research partnerships with Astellas Pharma, Inc. for solid tumor theranostics, with AVEO Oncology Inc. to create an Actinium-225 HER3 targeting radiotherapy for solid tumors, and with EpicentRx, Inc. to create targeted radiotherapy combinations with their novel, clinical stage small molecule CD47-SIRPa inhibitor. More information is available on Actinium's website: https://www.actiniumpharma.com/.
Investors:
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 430-7578
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-announces-positive-top-line-results-from-pivotal-phase-3-sierra-trial-of-iomab-b-in-patients-with-active-relapsed-or-refractory-acute-myeloid-leukemia-301662998.html
SOURCE Actinium Pharmaceuticals, Inc.
Released October 31, 2022
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