badgerkid
4 days 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.
surfkast
4 days 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.
Structural_Biologist
4 days 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 :)
badgerkid
5 days 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.
Dennboy66
5 days 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.
badgerkid
5 days 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.
badgerkid
1 week 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
badgerkid
1 week 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.
badgerkid
2 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.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
MN Gopher
3 weeks ago
Thanks Hawkeye, we should move one way or another after the Oct Cancer Conference with Allison Warner speaking about how Amtagvi had very strong unexpected “results” from the Melanoma patients, after tumor sample removed, waiting on the process to finish the TIL for reintroduction into the patient.
Brain Cancer was not present when treatment started, and now its there during the “waiting period” for their TIL Treatment Therapy.
Some patients were now ineligible to continue, not sure why & some continued with the TIL Treatment Therapy with Brain Cancer present.
TIL has a brain bleed known side effect, yet in the patients with Brain Cancer who received their individualized TiL Treatment Therapy, unexpected very good results rumored to have happened with only one patient getting a brain bleed.
The above is my understanding of the presentation in October by Allison Warner.
Will see then, but to me it sounds incredibly fortunate to have made a potential huge
TIL Brain Cancer Treatment “discovery” by “accident” treating Melanoma patients who progressed midtreatment, prior to any TIL Treatment Therapy to having a new brain cancer diagnosis.
Exciting times with Iovance helping humanity in my opinion “Cure Cancer”
#CureCancer
badgerkid
3 weeks ago
Some may view $12 as that level of support or of resistance. On the first full trading day following FDA approval of Amtagvi, Feb 20, 2024, IOVA traded between $11.31 and $13.41, with a close at $12.03 with 58,801,000 shares traded. There's likely quite a few retail investors that are happy to finally get back to even and are looking to exit after several months of much lower prices. We may just linger for a while longer in this $12 range. I fully expect we'll break to the upside sooner than later. But remember, we're also closing in on a large number of shorts that will soon be underwater with each move higher. Will they double down, or will they try to exit as well. All of this may play to our advantage soon enough.
Good luck to the longs.