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Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc (IOVA)

10.56
0.39
( 3.83% )
Updated: 11:31:13

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GMH* GMH* 1 day ago
The China trial that made Summit SMMT jump was also "Investigator assessed" which was a red flag for me. Independent assessments almost always arrive at a different/lower efficacy rate.
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badgerkid badgerkid 2 days ago
FWIW, FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology. Iovance is already ahead of the game on this which is good news. Here's the update: https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-conducting-multiregional-clinical-trials-oncology

This will be a concern for Summit and other companies who wish to eventually market in the U.S.
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GMH* GMH* 2 days ago
I think that it would very likely be a P 1/2 trial. Not going to treat healthy volunteers with this protocol and with the current Assay, I think minimum cell volume has already been decided. I don't think that would change with 5001.
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Structural_Biologist Structural_Biologist 2 days ago
Hoping they run a combined Phase 1/2 for that, it’s behind Obsidian in development but there’s room for both players and Iovance should also be established in 1L MM and 2L NSCLC long before the next gen TILs make it to market.

For now I’m most excited in seeing the upcoming data readouts in 2025 for combo lifileucel + pembro for MM, NSCLC, endometrial, etc.
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GMH* GMH* 6 days ago
I think the IOV-5001 product will truly be significant, but still pre-clinical so no data anytime soon. Also, genetically modified so will almost certainly require a P3 for approval.
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badgerkid badgerkid 6 days ago
Iovance poster presentation this weekend at ESMO: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation/list?q=1032P

Check out the abstract. Hopeful future next gen stuff.

Good luck to the longs. Have a great weekend everybody.
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Sunman88 Sunman88 7 days ago
I am impressed at the clear and concise projections and direction shared by leadership at the recent analyst meetings. Bottom line upfront: IOVA is on track to be a leader in cell therapy for melanoma worldwide and has geared up its internal infrastructure to support 5000 doses annually (over $2 Billion in revenue) with enough cash on the books to support operations in to early 2026. Demand continues to ramp up steadily in later stage melanoma patients. Major announcements to follow in 2025/2026 are 1. Rest of World approvals and sales for melanoma, 2. full approval in melanoma based on strong data in combination with Penbrolizumab for earlier lines of melanoma and 3. accelerated approval for NSC lung cancer in 2025.

Analysis: Amtagvi is a novel
Breakthrough product and IOVA has a deep pipeline with excellent execution record so far. Stock is overly shorted to keep eventual buyout price under check. I speak from experience with IMMU, IMGN and other similar small biotech buyouts. No matter what the little guy plans to do (bitch, moan, etc), hedge fund managers will short to keep share price under $12 for now and allow increasing revenue numbers and major news drivers to enable the share price to grow to $20 over time. Barring catastrophic news surprises, this will set the stage for an eventual buyout between $35-45 by late 2025 or mid 2026.

Plan: Hold and add more on weakness. Keep building core position for eventual buyout. Okay to trade a small portion of core position for sure term gains
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badgerkid badgerkid 1 week ago
Short interest continues to drop:
08/30/2024 57,686,674
08/15/2024 59,334,386
07/31/2024 61,318,556
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badgerkid badgerkid 1 week ago
Baird chat was yesterday, Wainwright chat is today at 11:00 ET (9/11/24). Yesterday's chat was definitely worth a listen. The archive of the chat is now available. If anyone is listening today, how about a report after the event.

https://ir.iovance.com/news-events/events-presentations

Good luck to the longs.
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badgerkid badgerkid 1 week ago
SB, some would say we just saw a gap fill over the last two days from the action following the Aug 8 earnings and guidance offered. On Aug 9, IOVA saw over 23 million shares traded with a range of $8.66 to $10.16. Here's the numbers on the day of release, and the first and second trading days following release:

8/12/2024 9.97 9.57 10.55 10.09 10,120,409
8/9/2024 9.39 8.66 10.16 9.92 23,625,123
8/8/2024 7.37 7.32 8.00 7.94 10,892,635

(These numbers are the open, low, high, close and volume for each given day)

I only offer this as one explanation - I'm not a technician, so it's worth what you paid me for it.
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surfkast surfkast 1 week ago
They appear to be trying to really ramp up quickly! Hope the PPS reflects a turn key operation this year!

FDA-approved cell therapy Amtagvi and Merck & Co.’s Keytruda delivered a 65.2% response rate in front-line advanced melanoma, including a 30.4% rate of complete responses.

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from Sept. 13-17. Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO Presidential Symposium Sessions. Data being shared at the Congress showcase the company’s continued progress in advancing clinical research for Merck’s broad portfolio and diverse pipeline of investigational candidates, with a total of 80 abstracts being presented.


(NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that senior leadership plans to present at the following conferences:

Wells Fargo Healthcare Conference
Fireside Chat: September 4, 2024 at 3:45 p.m. ET
Boston, MA
Baird Global Healthcare Conference
Fireside Chat: September 10, 2024 at 2:35 p.m. ET
New York, NY
H.C. Wainwright Global Investment Conference
Presentation: September 11, 2024 at 11:00 a.m. ET
New York, NY
The live and archived webcasts will be available at https://ir.iovance.com/news-events/events-presentations.
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Structural_Biologist Structural_Biologist 1 week ago
I find the price action today very interesting. Summit’s ivonescimab, a PD-L1xVEGF bispecific antibody, seems like a natural next gen for the checkpoint inhibitor. Interestingly, Instil Bio (ticker TIL) is a biotech that gave up both of its TILs and bought distribution rights outside China for 2 antibodies - one of which is IMM251, also a PD-L1xVEGF bispecific. And Instil Bio also had a 50% rise today because of Summit. And these PD-L1/VEGF antibodies are fantastic but at best would complement cell therapies like TIL and could be used in combination. And so, without even getting into the progress of their pipelines and how soon they could get to market, there is no threat to Iovance.

Interestingly, today the oncolytic viral immunotherapy company Replimune announced they had a pre-BLA meeting with the FDA and will submit a BLA application for accelerated approval for their oncolytic RP1 in combination with nivolumab for 2L melanoma this year. I think their ORR is in the low 30s and you need to get treated 9 times then you stay on nivo. Today their share price didn’t move at all at this news. Their application, when they submit, will reflect the fact they ran a single arm combo trial and a significant amount of the participants were Stage 3. Even if they do get approval, which would be sometime late next year, they will not take away from Iovance because there is a sufficient TAM for 2L melanoma to accommodate many players.

Given that there was no material news released today to affect Iovance, I found the price action interesting.

Thoughts are invited :)
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badgerkid badgerkid 1 week ago
There were rumors and rumblings, now we know. Check out the current job openings, incredible growth: https://www.iovance.com/current-opportunities/

Is this the storm before the sale? It's not the calm before the storm, that's for certain.

One thing is for certain, Iovance will be able to sell a turnkey operation fairly soon.

Good luck to the longs.
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Dennboy66 Dennboy66 1 week ago
Looks like Jim Ziegler VP of Commercial is no longer with the company

https://finance.yahoo.com/news/geron-corporation-announces-appointment-jim-201500018.html
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badgerkid badgerkid 1 week ago
What little I've read about Summit's trial, they've a long ways to go before the FDA would approve for U.S. market, but that doesn't mean that they won't get approval in China. I have no knowledge on how drug pricing in China works or if companies are limited in what they can earn given the nature of a communist nation. Also, I do believe that all of these drugs are still only fighting for second place relative to what TIL therapy is proving to provide with longer durability, longer responses, more cures, etc. I do believe Summit's drug may have its place if they can overcome some of the toxicity issues, but Merck will not sit by quietly if Keytruda is truly at risk from this potential competitor. I believe Merck has bigger concerns right now regarding patent expiration.

As with all news of this nature, cooler heads will eventually prevail and the price will adjust to the future revenue expectations (I would assume), though we've certainly seen lots of craziness around companies whose stock prices make no sense whatsoever. Again, I have no idea how to evaluate expected revenues in China.

And FWIW, Iovance is not actually part of this battle, but Merck may be so motivated to acquire Iovance sooner for the benefit of the combo to dispel some of the concerns coming from Summit or other competitors. Summit may be a better mousetrap over Keytruda (maybe), but TIL therapy is making the case that will put it ahead of these other options for frontline treatment even if some of those treatments become combinations that include TIL therapy. I still see TIL therapy and Iovance as the future of numerous cancer treatments along with its already successful and revenue growing Amtagvi.

Just random thoughts here regarding Summit. I haven't done nearly enough due diligence on that company to make my statements with certainty.

Good luck to the longs.
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Dennboy66 Dennboy66 1 week ago
That is a big move for SMMT. I wonder what the float is on that stock.
Will be interesting to see if there are multiple upgrades.
Too volatile for me to trade. I hate chasing.
Would look for a Fibonacci retracement if one comes.
I have a feeling that they will do a raise at these levels.
With Keytruda being such a huge part of MRK revenue, I can see why it is down with the SMMT news.

On a separate note, it will be interesting to see how IOVA responds to this news.
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badgerkid badgerkid 1 week ago
OT Dennboy, thanks. For me, this will be all academic as I'm not looking to trade Summit at this time, but I appreciate your insights. Let's see how it all plays out. No doubt it will be active. Lessons learned here only add to our knowledge base increasing our odds of making better trades and choices. On the other side of this coin, I notice that Merck is down a bit even though XBI is up slightly. I haven't dug deep enough for confidence, but it does seem to be a negative response to the news that Summit is potentially besting Merck's Keytruda.

Good luck to you.
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surfkast surfkast 1 week ago
Summit is surging pre market. Hope it gives us a boost.
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Dennboy66 Dennboy66 1 week ago
Badger

For traders, the best stocks to trade are ones with news with plenty of liquidity.
Everyday, traders look for stocks with news,upgrades,downgrades, earnings etc as all of these lead to higher volumes and more volatility.

I saw the news on Summit and thought that that was huge news. Traders always look at the ATR which is average true range - how much a stock will typically move in a day. For a stock like SMMT you would need to look at other big volume days to get an accurate picture. This will give you an idea of expected SP moves.
Now what may happen and what happens a lot is that much of the movement will be premarket. But their are a number of strategies that you can use relative to how it is moving.
Let’s say that it spikes 10% in premarket. Upon open you can look for an ORB - opening range breakout. You typically will use 3 - five minute candles minimum and if it is holding higher then upon the 4th or more candle - you can buy at the breakout. Your stop is then right below the breakout which gives you a solid risk to reward ratio. However, sometimes the small cap stocks like these are swinging wildly so you would limit your number of shares. Another strategy is wait for it to breakout and then pull back to the 20 sma or even better VWAP on the 5 min. Many times the stock will not be moving as aggressively with this strategy as it happens after the open. (I prefer pullback strategies). Also, you can do a Fibonacci retracement trade. We have a trader that has written a code that is imbedded in our trading platform that allows us to easily see the retracement levels. (This is my favorite strategy as it has the highest percentage of success - my belief is that the algos and large funds utilize fibs which in turn increases their value). Now with all these strategies you will have a very nice location to put your stop loss with a low risk to reward.
There are also day 2 strategies that are similar as stocks tend to move for 2 to 3 days unless the trend is broken.
With all that said, you have to be looking at the macro. With respect to bio, how is XBI and LABU looking that day. If they are selling off and SMMT is going up then that is very positive for SMMT. If the markets are selling off aggressively - like Friday. Then nothing may matter and even good news for a stock is dampened.
SMMT will be interesting tomorrow as that was huge news IMO.
FYI - the above are day trading strategies. Swing traders that hold for longer than a day will have different ideas. With a stock like SMMT, however, if it spikes up then many times you can count on an offering that evening. See it many times with small bios.
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badgerkid badgerkid 2 weeks ago
OT Dennboy66, Summit announced some big news today and will likely see a pop in their share price tomorrow. If you're willing to share before the market opens tomorrow, how would you play this news on Summit? Would you do anything? Even if you're not, what do you see as the opportunities, if any, on this news for the traders (not the buy and hold investors).

This is all meant to be theoretical, but based on our recent chats, it's a good example where news of this magnitude could benefit the trader if properly played. I'm truly and simply curious how you read it. I have no position in SMMT at this time and I have absolutely no intention to trade it tomorrow or anytime soon.

And if this is something that is better left unshared, I'm good with that as well.
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Dennboy66 Dennboy66 2 weeks ago
Thanks Badger. Great Post.
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surfkast surfkast 2 weeks ago
The swings here can almost be felt! Left $15,000 on the table. SMH
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badgerkid badgerkid 2 weeks ago
I agree with your process. With various stocks, I've gone short at times, I stayed too long at times, and I didn't always want to believe what was right in front of me which led to losses that I should have avoided. My point, I don't believe that most people have the discipline to know how or when to take their losses or when to lock in their gains. Shorting has unlimited risk, going long has limited risk. Making money should be the goal, but managing risk based on one's ability should also be factored.

I know from my own experience how easy it is to get out over your skis. That was years ago, but on these message boards we have investors and traders with all levels of experience. The last thing that I want to do is to encourage others to use sophisticated trading strategies if they have limited investing dollars and suggesting to them that it's simple. My point, it's not easy money even when you have all the right tools and strategies, but learning how to take advantage of opportunities should always be the goal while balancing your own risk tolerance.

I can do most of my other job in my sleep so to speak after years of experience, and it's very cash intensive. But I would never imply that it's easy for the novice even though many newbies I meet think it's all easy money. Most don't last which is unfortunate, but it's because they risked too much with limited knowledge after hearing all the glory day stories of the old cronies.

With regards to IOVA, I can truly state that I think it's a great investment with a significant amount of upside for the buy and hold investor - a very likely multibagger. For many investors, it has a great risk to reward ratio in my opinion. I also think it's a good trading stock if you're so inclined. Certainly, you can do both. I'm willing to sell puts and keep the premium if they don't put the stock to me. I may sell a few calls against my shares from time to time. I will occasionally sell some shares when it seems to have gotten ahead of itself, but I will always (assuming no major changes) maintain a core position because I also believe Iovance is an acquisition target and I'm willing to maintain a long position just for that reason (yes, some would say FOMO).

And on that note, have a great weekend. I'm outta here for the time being.

Badgerkid
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Dennboy66 Dennboy66 2 weeks ago
Well.. I guess that your could go that way. But why would one want to pigeonhole themselves into only making money from going long? Aren't there times when you see a stock that you feel just should not have that valuation? Why look for another stock to go long. Just take what is front of you. I make more money shorting than longing. Fear promotes heavy selling. FOMO provides heavy buying which leads to shorting opportunities. I am just saying that one should provide themselves all opportunities to make money in the market.
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badgerkid badgerkid 2 weeks ago
Dennboy66, my comment was directed at the typical retail investor. Your strategy is a legitimate job that requires attention to detail and a daily presence of mind that can ferret out those moments where that trade makes sense. Most don't invest the time and energy to find those occasional winners amongst the multitude of losers. It may be routine for you now, but there was a time that it wasn't.

Experience is the teacher, but often times losses knock many out of the game early due to unnecessary and uninformed risky plays. My point, it's a fool's errand for the retail investor - the investor who likes a company and wants to own it, who sees a future winner and is willing to wait. That's not a person who should be shorting the market. Right? If something has a 75% success rate, it implies a 25% fail rate. The game is won by playing all such moments equally with full knowledge that some will lose. The willingness to take losses while sticking to the plan is a very difficult task for most investors and traders. The gambler thinks they can pick the winners or they double down after a loss on the next play. Disciplined strategy as you seem to employ is a rare thing. I understand what you're doing and I accept that I'm not that person at this time due to outside interests and work that take me away too frequently to try trading at such a level at this time. That's also wisdom to understand our limitations even if they're only temporary.

But I do wish you great success.
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Dennboy66 Dennboy66 2 weeks ago
FYI - Shorting is not a fool's errand. One of the best trade set ups is a biotech that has not met its primary end point and tanks premarket. The likelihood of continuation is 75+ % during market open. It is one of my most profitable trades and I look for it on a daily basis. My ethics do not allow for me to short life saving companies, but otherwise it is free game and highly profitable.
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Dennboy66 Dennboy66 2 weeks ago
I hear you buddy. My living is trading. I knew that Sept. is the worst month of the year so i sold a large portion in 12s. My other rule is to sell the remainder of shares when at 10%+ of purchase price. Which i did. Stay to your rules. I will reassess, especially if IOVA recaptures 200 sma. that would be a technical positive. at the end of the day, I banked 150k. I will not just sit around and wait for positive news in a market sell off. I can always re-enter. Of course, just staying long and strong has it merits. I am more in the mind set of banking profits. IOVA has shown itself to be a trading stock which I fully plan on doing. We can always think that the large short interest are just a bunch of fools, but to me it is a weight. I sold in 10s and will look to re-enter when it recaptures 200 SMAf. I love this stock and its purpose.
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badgerkid badgerkid 2 weeks ago
Dennboy, the belief that shorts typically win is not accurate. The perception is a result of watching stocks seemingly lose faster than they gain (some truth to that, but it also assumes the short covers before the stock price recovers). For the retail investor, shorting is probably a fool's errand if operating from the belief that shorting is a more profitable way of trading and investing. I'm sure others can provide all of the nuances of how and when it works, but for those of us who are just your average investors, the risks involved in shorting are great indeed, or so I believe.
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badgerkid badgerkid 2 weeks ago
Surfkast, there's a long list of stocks right now that you can play the way you're suggesting. It's not just IOVA that's getting moved around with these wild swings. But yeah, if you want to watch the market daily, you, too, can be a trader. Just remember, most traders, and the vast majority of day traders, lose money. If you want to set targets and just leave your orders open to trade if and when certain targets are met, nothing wrong with that, it's your money, it's your rules. I always have a few of my stocks sitting with open orders to sell or to buy depending on what my strategy is or my target prices. I don't have any open sell orders on IOVA at this time, but I will consider it if and when we get closer to potential news dates. It'll only be a small portion though if I do.

Good luck.
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Dennboy66 Dennboy66 2 weeks ago
Sell off in market is real. Shorts typically win as fear is easier to trade than hope. The huge short interest here will not lose. Have sold my entire position to protect my gains. I can always re-enter - which I will.

There will be so many good bargains to come. IOVA included.

Oh and BTW - my selling is a huge indicator that the company will get purchased now :)
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surfkast surfkast 2 weeks ago
Do I have to start playing this like an OTC ATM? Got back in @$7.44 and could have flipped in the $12 range. Would have been close to $5.00 per share!
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badgerkid badgerkid 2 weeks ago
Yesterday's Wells Fargo chat confirmed all that we had hoped: guidance is solid and likely conservative; trials are continuing and data should be supportive of additional approvals; Amtagvi licensing in Europe, when approved, will add to the current guidance numbers; lung trial for TIL therapy is demonstrating a major improvement over current treatment options; requests by additional treatment centers wanting to become Iovance ATCs is a good problem to have.

The sound quality on this chat was vastly improved over past chats earlier this year. I recommend listening to the chat. These are not salespeople on the call which only adds to my takeaway of a very solid share of information - it wasn't sugar coated and it didn't need to be. Very solid future for Iovance.

The part of this chat that I take great comfort in begins at the 29:35 time stamp regarding the Tilvance-301 study. You know Merck's gotta be happy. Enjoy.

https://ir.iovance.com/events/event-details/wells-fargo-healthcare-conference-0
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GMH* GMH* 2 weeks ago
Agree... this is a market sell-off, not a stock specific sell-off.
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badgerkid badgerkid 2 weeks ago
First of three conferences tomorrow. Iovance Biotherapeutics to Present at Upcoming Conferences

https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-present-upcoming-conferences-14

Wells Fargo Healthcare Conference
Fireside Chat: September 4, 2024 at 3:45 p.m. ET
Boston, MA

Baird Global Healthcare Conference
Fireside Chat: September 10, 2024 at 2:35 p.m. ET
New York, NY

H.C. Wainwright Global Investment Conference
Presentation: September 11, 2024 at 11:00 a.m. ET
New York, NY
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badgerkid badgerkid 2 weeks ago
House cleaning all over the place. Some bargains available as well. Look around, there are deals to be had. Good luck to the longs.
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52172 52172 2 weeks ago
Holding all shares for 50 plus
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badgerkid badgerkid 2 weeks ago
3 Monster Biotech Stocks to Buy Before 2025
https://www.msn.com/en-us/money/markets/3-monster-biotech-stocks-to-buy-before-2025/ar-AA1pSCNx?ocid=msedgdhp&pc=U531&cvid=a517437f326f4da18e657f611c13419b&ei=63

Might be just a pitch piece from the MFers, but positive press is always appreciated.

Good luck to the longs.
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badgerkid badgerkid 3 weeks ago
Recent article about TIL therapy - this is a good read and a fair representation of both the good aspects of TIL therapy and of the challenges that remain for improvement.

https://www.sciencenews.org/article/newly-approved-drug-save-cancer-patient

HEALTH & MEDICINE
"A newly approved ‘living drug’ could save more cancer patients’ lives.
Amtagvi, approved for advanced melanoma, is the first T cell therapy for solid tumors."

By Meghan Rosen
AUGUST 22, 2024
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Dennboy66 Dennboy66 3 weeks ago
Thank you. Good intel. You may be right with the idea that Merck acquiring IOVA is getting some traction. There was a big spike at the open today. Now that could be straight up short covering OR people/funds starting to position more long due to Merck news.

Also XBI is ripping.
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badgerkid badgerkid 3 weeks ago
The point of the previous article is once again to show Merck's efforts to maintain market presence for Keytruda, their big money maker. Trials for Keytruda and various combos have been halted quite a bit over the past 12 months, but Merck's combo with Iovance's Amtagvi still stands up and needs to be recognized. I don't know if anything is going on behind closed doors at this time, but it's a card that may need to be played and could push Merck to finally make a play to acquire Iovance and add TIL therapy to its stable.
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badgerkid badgerkid 3 weeks ago
Merck halts two cancer drug trials for lack of efficacy
Investing.com 08/29/2024, 06:37 AM
https://www.investing.com/news/company-news/merck-halts-two-cancer-drug-trials-for-lack-of-efficacy-93CH-3592834

RAHWAY, N.J. - Merck & Co., the pharmaceutical giant, announced today that it is ending two Phase 3 clinical trials, KEYNOTE-867 and KEYNOTE-630, after recommendations from independent Data Monitoring Committees (DMCs). The trials were studying the effects of KEYTRUDA, Merck's anti-PD-1 therapy, on non-small cell lung cancer (NSCLC) and cutaneous squamous cell carcinoma (cSCC), respectively.

The KEYNOTE-867 trial, targeting stages I and II NSCLC, was discontinued due to the therapy not meeting the primary endpoint of improving event-free survival (EFS) or the secondary endpoint of overall survival (OS) when combined with stereotactic body radiotherapy (SBRT), compared to the control group receiving SBRT and placebo. The trial also reported higher rates of adverse events, including those leading to death, in the treatment group.

Similarly, the KEYNOTE-630 trial for patients with high-risk locally advanced cSCC was ceased when the data indicated that KEYTRUDA did not achieve statistical significance for recurrence-free survival (RFS), the primary study goal. While overall survival was not formally tested at the time of analysis, the results did not favor the treatment over placebo.

Both decisions were based on the lack of sufficient benefit to patients to justify the risks associated with the treatment. Merck has advised patients involved in the studies to consult with their physicians about alternative treatment options. Despite these setbacks, Merck remains committed to exploring innovative cancer treatments, particularly for types of cancer with high unmet needs.

Non-small cell lung cancer is the most common form of lung cancer, representing about 80% of cases, while cutaneous squamous cell carcinoma is the second most common type of non-melanoma skin cancer. Both diseases represent significant challenges in oncology, with high incidences and mortality rates.

Merck's clinical program for KEYTRUDA is extensive, with over 1,600 trials across various cancers and treatment settings. The company aims to understand KEYTRUDA's role in cancer treatment and identify patients who might benefit most from the therapy.

The information regarding the halted trials is based on a press release statement from Merck. The company continues to analyze the data from these studies and plans to share the findings with the scientific community and regulatory bodies.

In other recent news, Merck & Co. has embarked on a series of significant developments. The company has initiated a Phase 3 clinical trial for bomedemstat, an investigational drug aimed at treating essential thrombocythemia, a rare blood disorder. The European Commission has also approved Merck's novel therapy, WINREVAIR, for the treatment of pulmonary arterial hypertension, marking the first activin signaling inhibitor therapy in the European Union.

In a noteworthy business move, Merck & Co. acquired CN201, a clinical-stage bispecific antibody, from Curon Biopharmaceutical for an upfront payment of $700 million. However, the company had to halt its Phase 3 KeyVibe-008 trial for the treatment of extensive-stage small cell lung cancer due to safety concerns.

Merck & Co's second-quarter results for 2024 surpassed market expectations, with significant organic sales growth in its CM&E and oncology franchises within the Healthcare sector, and in its Electronics division. The company upgraded its full-year 2024 guidance, expecting net sales between €20.7 billion to €22.1 billion.

Finally, the Biden administration initiated price negotiations with the Medicare health program for 10 prescription medicines, including Merck & Co's Januvia. These negotiations are expected to save the U.S. government $6 billion in the first year from reduced prices on these leading drugs.

InvestingPro Insights

As Merck & Co. navigates the challenges presented by the discontinuation of KEYNOTE-867 and KEYNOTE-630 clinical trials, the company's financial health and market position remain robust. An InvestingPro Tip highlights that Merck has raised its dividend for 13 consecutive years, showcasing a commitment to returning value to shareholders. Additionally, the company is expected to see net income growth this year, which may reflect its broader strategy to overcome setbacks in clinical trials with a strong portfolio of products and a focus on innovation.

Turning to real-time financial metrics from InvestingPro, Merck's market capitalization stands at a substantial $297.59 billion, underpinning its status as a prominent player in the Pharmaceuticals industry. Its Price/Earnings (P/E) ratio is currently at 21.6, with an adjusted P/E ratio for the last twelve months as of Q2 2024 at 17.94. This indicates that investors may find the company's shares to be valued reasonably in relation to its earnings. Moreover, Merck's revenue growth over the last twelve months as of Q2 2024 is reported at a solid 7.15%, suggesting a healthy expansion in its business operations.

For those seeking additional insights and analysis, the InvestingPro platform offers more InvestingPro Tips on Merck & Co., which include information on the company's low price volatility, its ability to cover interest payments with cash flows, and its moderate level of debt. These factors can provide investors with a comprehensive understanding of the company's financial stability and potential risks. To explore these and other tips, readers can visit the dedicated page for Merck on InvestingPro.

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GMH* GMH* 3 weeks ago
So YOU were the overhead supply. LoL, Well done. Think we will be in an overbought situation for the next couple weeks. Hopefully tread water rather than down until we get there.
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Structural_Biologist Structural_Biologist 3 weeks ago
Ah, you have a huge position 😄 it only makes sense to have a core + trade around it when you’re able to!
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Dennboy66 Dennboy66 3 weeks ago
Watched the ticker today and the Ask was not aggressively loaded on every tick as before. This was overbought on the daily. Do for a pullback. I sold 35% of my position for about a 12.25$ average. But frankly, I was too overweighted into IOVA. I am a believer in “always be taking some profits and risk off the table”. I was up 25% on the shares I sold and with FIFO, I am at a lower cost average. I could have sold early but I always do. 😀. Still have 60k shares though.
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badgerkid badgerkid 3 weeks ago
GMH, good points made in your last few posts (as is typical for you). Shoulda, coulda, woulda - expressions that we hear all of the time with the stock market. Of course, I'm saying similar things but about why didn't I buy more shares when it was cheaper. As for my opinion, IOVA is still plenty cheap if you're willing to ride this into next year with at least 2 more quarters of earnings. Higher highs yet this year.

Good luck to the longs.
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GMH* GMH* 3 weeks ago
... and now we are starting to see those "should have sold" comments on the message boards... will need a catalyst to dig thru that overhead supply and get thru that $12 now.
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GMH* GMH* 3 weeks ago
I am pretty much aligned with the catalysts and Q3 earnings numbers you laid out. I do not generally put SP projections on specific events because the SP will do what the SP will do, but think these will all be positive catalysts moving us higher... and I hope your SP predictions are correct for the sake of my Jan 25 calls.
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GMH* GMH* 3 weeks ago
This makes sense to me as well. Often that overhead supply is at previous tops with people "wishing I would have gotten out when", but makes a lot of sense with that high volume and people just wanting to "get back to even". The one thing you usually see is on the comment boards people saying things like "I'm done with the garbage once I get my money back" or similar things and you don't see a lot of that so hoping that overhead supply is limited.
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GMH* GMH* 3 weeks ago
MN - I am looking forward to this presentation as well, but it was not an accidental find but rather an investigator (MSK) led P1 trial (see clinicaltrial.gov NCT05640193) with support from IOVA. There were 10 enrolled patients and I think ABW said one died, but others had response with minimal brain bleed issues (I am assuming).

It isn't the TIL that is the issue with the brain mets, but rather the IL-2 which causes capillary leaking (one of the many side effects) which is especially problematic in the brain. Hopefully this study will lead to an adjusted FDA protocol allowing some patients with uncontrolled brain mets to still be treated.

Will be interesting to see what they present. Should be good for IOVA and patients.
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surfkast surfkast 3 weeks ago
If what we are seeing and hearing, I believe $20 by year end is very doable. Unexpected good news and who knows?
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