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Sure has def going to be a fun year!
The Motley Fool has also issued a very good report on IMGN. I believe we'll see an equally strong move when TLD for Mirasol is released shortly. I would not be surprised to end the year well into double digits.
I think that we should see an approval in BPDCN next year. I never realized how bad a condition it is until I saw the video and our drug worked like a miracle.
Gary
Nice stock price jump today on better than expected Elahere sales and a lower than expected loss. The phase 3 MIRASOL trial also reached the pre-specified number of PFS events, so the trial data will be available in mid-May. Good times look like they are finally coming for IMGN investors. It has been a long wait.
https://finance.yahoo.com/news/immunogen-reports-recent-progress-first-103000648.html
Here's a new report on using MIRV.
https://www.medscape.com/viewarticle/990285#vp_1
I believe awareness is growing and some data should be released at the next quarterly probably at the end of this month. We could get Mirasol TLD any day, again it should come before the quarterly report, I believe it will be positive and could spur new partnerships for distribution and sales in countries that IMGN doesn't intend to deal with themselves.
Gary
Ed, I think it's all predicated on what the Mirasol findings are, and I like the fact that the event that triggered the end of the trial was months after it was originally predicted. The price you mention might be possible if we have a failure, but I believe it should be a screaming buy at these sort of prices.
I will admit, right now it's price is below my average and it's possible that even now I'll sell a little to purchase solar, which I've contracted for and plan to pay cash for rather than financing. If Mirasol is positive, I think we could be above $5 in a day, more importantly I think the Analysts who have our target around $20 will be right.
I also believe that when the company does a forecast for MIRV sales it will be a positive, regardless of the figure. I understand them wanting some degree of accuracy, but earnings estimates will certainly improve when some sales volume is included in the figures they're providing.
Hope all is well with you.
Gary
Unfortunately looking at the chart it looks like it is heading towards $2.38…
Unfortunately looking at the chart it looks like it is heading towards $2.38…
That didn’t work out in the long run.
After months of anticipating the conclusion of Mirasol the company has said it concluded at the Cowen conference, here's a link:
https://investor.immunogen.com/events
While Top Line Data will take about 8 weeks, I think it would have been nice if they issued a PR on the trial completing but all and all the Cowen presentation which had several companies speaking clearly identified IMGN as a leader among them. All is good except the stock price, which frankly is hard to understand. The company has been down since announcing approval and advancement of other drugs, we should be at or near annual highs instead of being near annual lows. I know some here don't like my saying we're being manipulated, but what else explains it.
Gary
Ex,
I believe that T-DM1 made Roche a lot of money and is still a big seller. Unfortunately it was virtually IMGN's first successful test of their technology and they did the partnership from weakness so the financial gains weren't that great in the first place, but they choose to monetize them before they came to fruition, so naturally they did so at a substantial discount on what the could have earned, but they needed the money ITHO. I frankly wish that they more freely diluted when share prices were high, I think that's been SGEN's road to success more than their products. They had far more to spend on product development because they diluted at high share prices for big money.
Gary
To be clear, I meant I bailed after that trial failed. I took my financial lumps.
I too was very disappointed. Given how solid T-DM1 was across all datasets prior I really expected a win.
Lesson learned. No matter how good something looks, there is always real risk.
Garry, I mistakenly posted on this message board when I meant to be on another. So I deleted the content of my post (as I can not delete a post).
I have no issue with your hope that the level of interest will pick up a bit. It was a long cold winter after Kadcyla failed in front line, and I sat it out on the sidelines. But time to be back.
Some will be boring though. Mirv will be about execution. Still, commercial stuff maters.
Do you have two identities, only the author should be entitled to say he put the comment on the wrong board.
I do expect the next few years to be good ones for IMGN. The company has operated for many years without an approved product that was essentially their own. Now we have one approved, and the likelihood of one or two more in the next few years.
In the next couple months we should get Mirasol results and confirm the success of MIRV which ought to bring more approvals, and probably partnerships to cover distribution and sales in places in the world where the company has indicated they're not looking to market in themselves.
I'm not suggesting that we have the same potential here as in NWBO, which could easily be a ten banger in a couple years, but a five banger in that time is very possible, and while I'm not looking for a buyout, some believe it's possible and if it's a year or two out it could be a ten banger by that time should it occur.
Gary
Next couple years should be fun.
I really don't know whether IMGN will partner by country, or get a ROW partner and while you're right about how much will be paid by country, much of the worlds population is included in what's left after removing North America, Europe and China. Economically there is a great deal of development in third world countries so I believe earnings could still be substantial, even if the price of MIRV is reduced.
The question that really needs to be answered is whether MIRV has significant benefits in other platinum resistant cancers. I believe we'll get anecdotal evidence in the reasonably near term, and trials initiated that will take a little time to mature in the not that distant future.
Hopefully it won't be that long before we're also seeing news from other trials. BPDCN is very probably our next shot at approval and once again that drugs is also targeted at AML, so off label use could come prior to approval. As a patient of PH+ ALL I know that many therapeutics are used in this venue that aren't specifically approved for the form of leukemia they're being used for, and they are effective.
I can't help comparing IMGN with SGEN. Clearly there is a huge disparity in their market caps, and I don't think it's properly borne out by their technology. It's certainly not borne out by earnings as SGEN is losing more per share than IMGN. Clearly SGEN can raise money far easier at their dramatically higher share price, but I still believe that IMGN is a bargain at this price when compared with SGEN.
Gary
IMGN has always been a fairly straight shooter on estimations, so I agree that the next few weeks are fairly likely. They did not say Q1 or H1.
I agree that Mirasol is very likely a success. Based mainly on the fact that we know the FDA looked at the Mirasol RR data prior to approving. OS may not yet be mature, so might not have that yet.
As far as other jurisdictions, the only other one of serious value is Japan. And they tend to be picky about having trials in Japan, so that will be aways. Australia , S. Korea, Taiwan etc do not move the needle on biotech valuation.
Any thoughts on when we hear of Mirasol trial reporting. The company has said early 2023, I think that we're about there, don't know that it will be next week, but should be in the next few weeks. I have no reason to believe that Soraya won't be confirmed by Mirasol and that should start a move to higher prices and partnerships to cover parts of the world that IMGN isn't looking to keep for itself, namely North America and Europe. We know China is currently working, but others areas are up for the taking.
Gary
Elahere has been established as the preferred treatment, here's a link:
https://markets.businessinsider.com/news/stocks/immunogen-s-newly-approved-ovarian-cancer-drug-listed-as-preferred-regime-1031992687
Perhaps now we'll see the share price growth that failed to occur when we got initial approval.
Gary
ASH starts in a week, does anyone know if we're presenting there.
Gary
Your set just hold for 100% gains will be easy.
I agree thanks Gary im golding long another 1-2 years should get this much higher.
Estimates are all over the place, I believe $1 billion by 2024 is fair for now, but the big question is expansion into other cancers where substantial percentages are platinum resistant. If anecdotal evidence builds from off label use MIRV certainly could reach a few billion or more in a few years.
Gary
Analysts (3) giving good vibes about the company future,I like the options !!!!
Gary- What is the expected revenue from this approval? I got here since you mentioned this stock in other board. Tia
Sorry, you're not paying attention, they got the approval on Monday after the close. Sadly the market isn't seeing the earning potential as that great, however Analysts are upgrading to the $20 area and I'm sure we'll get there in time.
I hold December $6 and $7 calls, I still think both could be in the money in just over a month from now, but time will tell. As an investor from the time the company came public I'm saddened by the Streets reaction to the approval, but give it time, I think we'll be fine.
Gary
I answered my own question. IMGN’s press release stated an independent third party did the the unblinding of MIRASOL trial to get data the FDA wanted. That means the trial is still unblinded.
I answered my own question. IMGN’s press release stated an independent third party did the the unblinding of MIRASOL trial to get data the FDA wanted. That means the trial is still unblinded.
IMGN is over 90% owned by Institutions. I believe that they are shaking the trees to add cheap shares. Our market cap is just over $1.1 billion. I don't think that you can find another biotech with an approval potentially blockbuster drug with a market cap that low where the company wholly owns the product in most of the world.
Gary
12000 shares 5.8 average. LFGO I’m down but buying
But dude, down for the day on an announcement of conditional approval???
GLTA
There is some good news on the MIRISOL front today.
The FDA used ORR data from that trial to grant the label that includes bev naive patients. So ORR did well in MIRISOL.
That is not the primary endpoint of course, but does point to a likely positive trial result.
The FDA granted conditional approval. Continued approval will require results from the MIRASOL trial, which should be in later in the year or early in January. FWIW, I increased my IMGN shares by 10% this morning at $5.21.
I won't be listening in at 5 a.m. my time tomorrow, but I'd like to hear from those who do, I'll read about it later. Here's a link to the release discussing it:
https://www.businesswire.com/news/home/20221104005657/en/ImmunoGen-Announces-FDA-Accelerated-Approval-of-ELAHERE%C3%A2?%A2-mirvetuximab-soravtansine-gynx-for-the-Treatment-of-Platinum-Resistant-Ovarian-Cancer
Congratulations to all, especially those who've been in IMGN from it's beginning.
Gary
Nice call Gary. Thanks!
I think the odds are about even that they'll announce approval this week rather than waiting. The FDA knows enough about MIRV to act early.
Friday they were shaking the trees for cheap shares, I think we'll move up this week whether we get the approval early or not in anticipation of the approval by the 28th at the latest. The FDA has no reason they can't make the decision, if there is a further delay I've got to believe that we've pissed of someone at the FDA, probably with the last name Padzur.
Gary
Thanks ex! Fancy meeting you here!!
Per the CC we know as a fact that the FDA has not requested more information as of now. The risk that the FDA would say they need to wait for MIRASOL data looks to be off the table.
Odds on an approval this month look very good.
If you believe as I do that MIRV will be approve on or before the PDUFA date of November 28 you might want to consider what I'm purchasing, December $7 calls. If I'm right, and if our share price goes into double digits, which I expect, even at exactly $10 with margin you can borrow $7, which is what I'll be paying for the shares. I expect the share price to be higher than $10, if so the share I'm adding will be adding more to my available margin than what they'll cost me on margin. Of course my other shares will have added over $50K to what's available on margin to me.
If I'm wrong about this, we all may be in trouble with IMGN. Approvals are never 100% but I believe that this time we're very close to that.
Gary
I don't know if todays move is based on anticipation of approval of MIRV, or if perhaps many people are discovering this video on BPDCN:
Thanks David, I'm not into TA myself, but have a healthy respect for those who are and know what they're talking about, you see to and I like the fact that you're also looking at future event.
Gary
40 dma line about to pass 10 dma. Quite bullish!
https://stockcharts.com/h-sc/ui?s=imgn&p=W&yr=3&mn=0&dy=0&id=p41172935245&a=448223238&listNum=25
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http://www.immunogen.com/about-us
http://finance.yahoo.com/q/h?s=IMGN
Our mission is to be the leader in the application of monoclonal antibodies for the treatment of cancer. We aim to achieve this by exploiting our expertise and experience in the identification of potential biological targets for cancer treatments, the development and humanization of monoclonal antibodies, and the creation of potent cell-killing agents designed for delivery by antibodies. Our Targeted Antibody Payload(TAP) technology uses tumor-targeting antibodies to deliver a highly potent cell-killing agent specifically to cancer cells to kill these cells with minimal damage to healthy tissue.
We are committed to the highest standards of scientific excellence and integrity for the benefit of patients, the medical community, our partners, shareholders and employees.
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