Impossible to time this; never know when it will pop or dip.
where is incy in RETREAT... Dumb tom...
Still trying to figure out what's going on at Lilly. Still don't know what FDA objected to. But I have a thought.
Plugged a few figures into the AHA heart attack risk calculator. The reduction in HDL with JAK2 inhibition could lead to a couple tenths of a percent increase in heart attack risk over 10 years (other things being equal, which of course they aren't). There is no imaginable way that this level of risk increase could be rejected at the 95% confidence level with 10,000 patient-years of data (ESPECIALLY if the risk is expected to be concentrated in out-years and few of those patient-years are from more than 4 years of exposure). Normally, FDA doesn't get hung up on a theoretical adverse event that hasn't actually been observed (and make no mistake, increased rate of heart attacks has NOT been observed in the Lilly trials). But Olumiant is a drug meant to be taken for many years by many patients with a condition not generally considered life-threatening. And FDA got two black eyes over the COX-2 inhibitors, anti-arthritis drugs that increased risk of heart attacks (as it turns out years later, by a tiny amount that was clearly outweighed by other AEs that they avoided, but it was quite the scandal at the time). If 100,000 people take Olumiant, a 0.1% extra risk of heart attack (percent of total, not relative to baseline risk) is 100 in 10 years. That's a sizeable risk for FDA, and of course, if you start talking about it. everyone taking Olumiant who suffers a heart attack (that's north of 4% over 10 years) is going to sue, so Lilly is justified in treading carefully.
This small theoretical risk clearly wasn't taken account of in dose determination, so that part fits.
Lilly, of course, wants the largest possible label indication AND protection from lawsuits. So it would make sense for them to be doing every imaginable analysis of subgroups contributing to the risk estimate and of experience with Jakafi (which affects blood lipids worse and doesn't seem to have an adverse heart effect--but lowers platelets, which independently counters that risk). The desired outcome would be to come up with zero-CV-risk and excessive-CV-risk subgroups, and a risk mitigation strategy that wouldn't need 10+ years of testing.
Just guessing, of course. And I'm not sure how this would tie in with late completion of the '5705 trial. But the combination of having to satisfy both FDA and the personal injury lawyers could make the delay continue several more months.
Attention, attention, Maddison! When all you do is just throw out some fantasy buyout price it doesn't mean you have any meaningful understanding of INCY's value. If what I said is clueless then please for the love of decency tell me why you are clue-ful.
Don't hide like a coward this time. Why don't you stand up and really show everyone here why I'm wrong and you're right? Here's what you can do to really demonstrate to everyone why your estimates make sense.
I'll keep it simple: The reality is INCY only earned $100 million but the cap is swollen 200-300x. It's swollen on buyout rumors. If you think INCY will be bought at $200-$300-$400/share, then tell us how much earnings justifies that price? Or do you really think with only $100 million earnings a buyout price of $300 is justified? Because at $300/share the buyer won't break even for 600 years, assuming technology doesn't improved and not accounting for inflation.
But you and your pump squad love to say a buyout price won't be based on earnings, right? LOL Then what the devil is a buyout price based on? Phantom earnings? Phantom drugs that aren't approved? Why on earth would a buyer pay a premium for drugs that don't exist? Are buyers lining up to pay a premium so they can risk even more money on developing pipelines? Why wouldn't these buyers just let INCY take all the risk on the pipeline in the first place? Why would these buyers pay a premium to buy all that risk?
Or is your clue-ful assumption that once the jakafi market matures then INCY will suddenly be making orders of magnitude greater earnings? Really? Is your buyout price based on jakafi alone? Besides the competitors in development for jakafi's jak inhibitor market, do you realize how fast immuno is developing? Who knows what new drugs will exist in 5 years. Jakafi is a risk all by itself. Jakafi might never see a mature market. That's the reality. Any buyers will inherit that risk, they have to think 10-20 years ahead. Breaking even for them means losing money. Even supposing jakafi reaches maturity, what's that market worth? Jakafi doesn't help anywhere near the total population of that market. And more than 80% of patients quit jakafi in 3-5 years. Show me the money.
So lay it all out for us Maddison:
1) What is your buyout price estimate and how much earnings does INCY have to earn to justify it? 2) Is that price pinned to just jakafi's earnings? Or what else and in what proportion? 3) How long will it take to reach those earnings goals? 4) Most importantly, does earnings just not matter at all to you? And you just expect a buyer to assume all the risk while also paying a several-hundred-times premium? Is it the buyer's privilege to just throw cash at INCY and swallow all that risk? Why don't they just do that with even cheaper companies? What makes INCY so essential that buyers should pay a premium for a mountain of risk? Would you do that with YOUR money?
Your idea of a buyout is gaseous. You don't actually have any idea or metric of what the price should be based on. All you think is that INCY made some money on jakafi and INCY has a pipeline, and that's it, and that's automatically worth 200x or 300x or 400x earnings or more. But the actual pipeline and the actual earnings, the real drivers of business, you left out all that stuff in some vague cloud of blind enthusiasm, but you don't really have any idea, do you?
What I said is the sound market standard. P/E of 20-40 is solid, and that puts INCY at $20/share. Even 100 P/E for a developing company, depending on the company and market, could be palatable... and that puts INCY at $50/share. But 300 P/E puts INCY at $150/share and that isn't just an overestimate, it's comic, it's really hyperinflation. And yet some of you even believe it should be 400 P/E. BASED ON WHAT?
Maddison, don't dodge these questions. Speak up for the longs. Give them some ground to stand on. Don't let jacosa beat you to it. Stand up for yourself. If jacosa wants to answer he should wait till after you.
must be mkts are down so incyte is down, ibb, and almost all bios are GREEN, can't even buy a green day with news, getting uglier as it turns into nearly 110 DAYS WITH NO NEWS
Tommy, J'off, B and Yellow...hurry....hurry...time to run over to Vertex...up over $35 on Stage 1 and 2 news just out. Whoa, way over valued and GILD won't be able to touch them now....and you must harass those because I'm sure those longs are way out of touch about its current valuation!!! Run Tommy, J'off, B and Yellow Run!!
IBB on fire, S&P up, ow up NAZ up,
LONGS PUMPING doom and gloom to the shorts and
INcyte will go red today
maddi, says this man is a hack on the article he wrote on incyte, seems like his credentials are as good as any worthless analysts out there , next we will here that Jacosa knows more than the analysts
Michael Kramer is the Founder of Mott Capital Management and runs MCM's actively managed long-only Thematic Growth Portfolio
Touched back into the $120's today. But I bet none of the dreamers are willing to call it volatility still. They saw it touch $135 last week and thought $140 was a sure thing, and from there surely $150, and then it's a given that some bold and daring CEO would risk his career, future and dignity by offering $300/share. The dreamers just don't appreciate the absurdity of that buyout scenario.
If there's a buyout it'll happen at a reasonable price somewhere near reasonable P/E. No one's paying for the rights to a phantom pipeline and then pouring even more money into that pipeline with childish hopes that it's all going to turn up spades. Right now a generous buyout would be $10 billion which still puts INCY at an astonishing P/E of 100, with a premium at a price of $50-60. If you want to include any near future revenues, then add $20-30 for an even high premium offer. That's an offer based on cold hard earnings as all offers should be. Those are the realities of this business.
There have been several ostensibly positive developments but the price stagnates and that's because none of those developments make INCY worth 200-300x earnings. You dreamers still haven't grasped the difference between price and value. The one thing that can make INCY really worth the current market cap is if this year they magically earn about $1 billion, compared to last year's $100 million. Unless that happens INCY won't hold this market cap.
Tom stated INCY red -- looks like he is right again.
Tom = 100% 4 stooges = all zeros 00000000000000000000000000000
The shorts are getting nervous, crying and spitting like pigs going to the slaughter! 😁🤣😁😁😁😁😁😁😁😎💣🖕🏼
I see that the phase 3 of itacitinib against acute GVHD has begun. For the hotter-money players, this ought to move the "resting price" of INCY up a couple of bux--a candidate generally acquires value moving into p3.
Generally, this is going to define the pharmacology of 'ita' a whole lot better. We ought to learn more about the candidate over the next few months--so far its kinase specificity looks good but it seems to have some "unrelated" binding. I see nothing about metabolism. The dose is in the hundreds-of-mg-daily range, so that stuff may matter.
Safety of the combination with steroids in a biggish study will be interesting.
Final data collection scheduled for April, 2019. Nature of GVHD is such that there ought to be hints of how things are going along the way.
Tommy how you feeling about your $130 prediction for tomorrow?
options expire tomorrow, so longs .......betting it closes under 130
Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft – Versus – Host Disease
20 July 2017 13:30
For best results when printing this announcement, please click on link below: http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20170720:nBw5Y90r1a Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host Disease Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in GRAVITAS-301, a pivotal Phase 3 trial for the first-line treatment of patients with acute graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel, potent, and selective JAK1 inhibitor, in combination with corticosteroids compared to placebo plus corticosteroids in patients with acute GVHD. “Today, there are no approved treatment options for acute GVHD, a severe and life-threatening condition that can lead to tissue damage, organ failure, and death in certain transplant recipients,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “The initiation of the GRAVITAS-301 trial represents an important milestone for Incyte as we continue to progress our clinical development portfolio, and we look forward to further evaluating the potential of itacinitib to address the unmet needs of patients with this potentially devastating condition.” GVHD is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue), whereby the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. GVHD can be acute or chronic, and is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with acute GVHD. About GRAVITAS-301 GRAVITAS-301 (NCT03139604) is a randomized, double-blind, placebo-controlled pivotal Phase 3 study evaluating itacitinib or placebo in combination with corticosteroids as a first-line treatment for patients with acute GVHD. The study will enroll approximately 430 patients 18 years or older who have undergone one allogeneic transplant from any donor and any donor source for a hematologic malignancy or disorders. The primary endpoint of the GRAVITAS-301 study is overall response rate (ORR) at Day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. Key secondary endpoints include non-relapse mortality at Month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse, duration of response, and ORR at Day 14, 56, and 100. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2 (http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03139604%3Fterm%3Dgravitas%26rank%3D2&esheet=51592041&newsitemid=20170720005224&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03139604%3Fterm%3Dgravitas%26rank%3D2&index=1&md5=3b1ffd7adfb0318b44af08de589a4145) . About Itacitinib Itacitinib (INCB039110) is a novel, potent, and selective JAK1 inhibitor currently in clinical studies for the treatment of treatment naïve GVHD and non-small cell lung cancer. Global development and commercialization rights for itacitinib are wholly-owned by Incyte. About Incyte Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com (www.incyte.com&esheet=51592041&newsitemid=20170720005224&lan=en-US&anchor=www.incyte.com&index=2&md5=3acfe00018a66b328d9da3232957ee0b" target="_blank" rel="noopener noreferrer" class="C(#188fff)">http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.incyte.com&esheet=51592041&newsitemid=20170720005224&lan=en-US&anchor=www.incyte.com&index=2&md5=3acfe00018a66b328d9da3232957ee0b) . Follow @Incyte on Twitter at https://twitter.com/Incyte (http://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2FIncyte&esheet=51592041&newsitemid=20170720005224&lan=en-US&anchor=https%3A%2F%2Ftwitter.com%2FIncyte&index=3&md5=7c806ac9fa19ff29a34313e071798637) . Forward Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the Company’s plans and expectations for the GRAVITAS-301 program, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments and the risks related to the efficacy or safety of the Company’s development pipeline, the results of further research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, other market or economic factors and competitive and technological advances; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2017. Incyte disclaims any intent or obligation to update these forward-looking statements. View source version on businesswire.com: http://www.businesswire.com/news/home/20170720005224/en/ (http://www.businesswire.com/news/home/20170720005224/en/) Incyte Corporation Media Catalina Loveman, +1 302-498-6171 firstname.lastname@example.org (mailto:email@example.com) or Investors Michael Booth, DPhil, +1 302-498-5914 firstname.lastname@example.org (mailto:email@example.com) Copyright Business Wire 2017
tom lost is big mouth, he's waiting for a pullback that will not happen, sorry my big loser
Please everyone stop replying to "B". If the only thing you can bring to this MB is a cartoon maybe you should go back to school and get an education..... You really are not funny.....it only shows your immaturity....
NVS Jakavi sales $186 million compared to $162 for first quarter! WOW! Won't be long and NVS will be on a billion dollar a year run rate...
still wondering what has happened to the loud mouth, name calling, finger pointing, worthless excuse for an indiviuals, pumping longs have gone to ??????
so longs, i have noticed very slight rebuttals of your hyping by Jacosa, seems you have over look them and keep right on pumping, did any of you read what he wrote on bari sales today?
here is a reminder, of just a few of your hyping wrongs in the recent past
AARC with 23 abstracts......hyped pumping, stock goes down ASCO with 15 abstracts ...hyped pumping, stock goes down Bari approval in the US, FDA SLAMS the door....stock pummeled
now comes the insane pumping on how MASSIVE the bari sales are going to be in the EU......do any of you worthless pumpers committ on what Jacosa says???????
I hear how good the sales are for Ruxo for NVS......so it has to translate into huge sales for it in the US.... ok so what.....Incyte is spending money so fast that Ruxo needs to do nearly $1.5 Billion to stay ahead of the spending curve. I also hear about all the NEW opportunities for RUXO, there is not much happening, what is it???? when will it come to mkt? potentially 2019 or 2020......by then there could be a ruxo competitor...who cares
it is nearing 70 business days on bari FDA crl, with no news, nearly 100 days in total......hmmmm quickly becoming a THIRD of a year with out a peep. Jacosa talks about it is worse not knowing anything , than having a decision, again pumping longs are not listening. so what happens if they want another p3 study, that is far from the gentler, kinder FDA, especially with the SWIFTNESS of what has happened in the UK and Japan. This will likely cause another huge bear raid in shares with at least another $20 a share gone. Abbv is not far behind with their jak drug for RA, and longer it takes for an approval the less in roads Lilly will ever make in RA...as no one knows the RA market and has a better salesforce than ABBV.