It's getting close to time for the company to decide what condition to target with this candidate. FDA is unreceptive to claims that you have developed The Panacaea. I guess lung cancer would be about the largest patient count for a manageable registration study.
The problem for shorts is that management knows how to skyrocket the share price (gestures of friendliness to owners), and might do it if a bear attack became embarrassing.
This drug is at least 3 years from market. It is a monoclonal antibody, which makes it an undesirable drug for long-term treatment (dosing of monoclonals tends to be intrusive). Some [on-target] side effects are expected from completely blocking a growth factor; larger sample size is needed to characterize them. The actual improvement reported in some patients is highly encouraging. The degree of improvement is well short of a cure, and there is no obvious reason why this drug should not be given simultaneously with Esbriet.
Overall, this report strikes me as neutral for Intermune.
But an excellent underlying for options transactions. Consider, for instance, selling Jan 2015 puts naked, or buying the stock and selling Jan 2015 calls. Strikes of 35 or 40. Or as a pure option play, buying the 35 call and selling the 45. These kinds of transactions are sweeteners you can add to a successful long position to harvest a little extra gain without adding much risk.
I HAVE outsmarted myself in the past with complicated option plays; these are simple and have little in the way of traps. But DO diagram price at settlement vs return for any strategy you don't know well, and consider your response to an assignment. Consider the possibility of rolling favorably, too.
I've seen almost every variation on timing (except very late publication of favorable results...wonder why that never happens?). I think the prejudice here is toward early announcement. For some reason, execs here are very sensitive to possible legal problems, and the best way to head off suspicion of trading on non-public information is to get it public right away. So unless there's something odd like a direct conflict between raw primary and secondary endpoint reads, I'd expect a top o' th' topline release within 2 weeks of primary completion. The really slow analyses happen when many subjects leave the study and multiple treatments of missing data have to be generated. Part of the protocol for ASCEND is aggressive action to avoid missing data, and in the last CC it was stated that subject drop-outs have not been a problem. So I'd put the most likely first announcement right about at the earliest plausible date, say second week in March. But data collection could drag on an extra month and there could be tricky calls. Basically, I think that a mid-May first read wouldn't be a happy one.
Given the old advisory panel and European clinical experience, even a 10% chance that placebo did as well as drug would probably give us a good chance of US approval, but the stock price probably wouldn't take off ahead of time. We want full significance, and we want it NOW
I answer people like you the first time.
You seem to think that something from Geron might make a business difference to Incyte. Let's engage in some fantasy: suppose a drug made MF go away every time and stay away. It STILL couldn't take a single patient away from Jakafi treatment in less than about 15 months. But all that's going to come out Dec 9 is 6 months data on a trial with no pre-announced protocol enrolling 30 patients. And we already know that there were too many deaths in the group (yeah, yeah...but it's true) At the very least there will need to be a p2 to determine dosing and a p3 to establish safety and efficacy.
And as for Incyte's prospects, Jakafi for MF is not the greatest driver behind the company.
I notice that any drug backed by Tefferi gets enthusiastic followers. I hope he doesn't ask patients to pump his hobby horses.
Mar 15 calls 25 cents asked.
Most hopeful thing I can think of short-range is that some of the present pain is tax loss selling.
Just saying. We've hit Rachel McMinn's published price objective. If you go back to her sum-of-parts valuation and try to correct the numbers she says to a decent estimate of what she means, you (well, I) get a number in the mid-60s. So let's say no longer DEEPLY undervalued. People get giddy and irrational at these heights. I'm no longer saying NO takeover bid. You'd have to be nuts (or very very confident) to make a $60-ish offer for a $30-ish company knowing that there was a good chance you'd set off a chain-reaction leading to either you or a competitor buying it around $130. It still doesn't make SENSE, but, well, giddiness.
This appears likely to be an off-target toxic effect, so while records will certainly be reviewed, it isn't likely to point to a new Jakafi side effect.
I have no idea what the stock will do near-term. ITMN is unlikely to move much in tax selling / window dressing season (although there is SOME tailwind). Again, as a small growth company there is a January tailwind too.
Clinicaltrials.gov says primary completion of ASCEND is expected in February 2014. That date has some slop in it, of course. It also takes an unpredictable time to process the results. Generally, I'm sure that topline results will be reported some time between last week in January and second week in June (no sense going out on a limb). Positive result with full significance on the primary measure, announced by mid-March ought to move ITMN above $30 right away. Negative or low-significance positive result will hurt the price, at worst dropping it to the $5 range. Management has said that they will seek FDA approval should there be a low-significance positive result, creating another season of nail-chewing. Delay in topline report beyond mid-March is also likely to hurt. There ought to be publications on European clinical experience by Spring (I'm a little surprised we've seen so little to date), which may cushion the bottom of that range a bit. Let's use a SWAG (simple wild#$%$ guess) of 80% chance of a favorable result from ASCEND (recall that enrollment was slowed by absolute insistence on the enrollment criteria, and the trial was designed to have a 90% chance of success based on the historical database). Attempts to look beyond the topline report on ASCEND cause my crystal ball to overheat.
Where do you find a flat assertion that symptoms resolved? Ceo remarks sure suggest that they didn't [yet].
Something else that Geron partisans seem to miss is that even complete cancer remissions tend to be temporary. MF and the other MPNs are chronic diseases, so duration of treatment effect is very important. There is no imaginable way to tease duration of response from available data on Im.
Better yet, don't listen to me, but think about things like cost of a registration trial (depends on size and duration) and ultimate fit with the sales force. Think of Ruxo for PaCa as a proof-of-concept [likely to remain off-label, too] rather than a real program. The real program is whatever JAK inhibitor they pick to target all solid cancers meeting the magic criteria.
Do YOURself a favor. Get a notebook and write "Good Ideas" on the front. Write your good ideas, including Geron in the notebook. Update it at least once a quarter. You MIGHT still want to buy Geron in a few years when the Imetelstat p3 is a couple months from primary completion. The other favor you might do yourself is learning that Tefferi's stated opinions are less than worthless (I'd still want him treating me if I had a MPN)
The TOPPER is the use of a reverse merger to change the company's governing documents. For those who don't instantly see this: suppose that there was a private equity buy-out. The BoD COULD vote to amend the governing documents so that class B shares would get much more per share than class A shares... only they would be individually and personally liable to lawsuits for sure, and maybe to criminal prosecution (It is my understanding that board votes are legally discoverable, but board discussion is not). On the other hand, new governing documents could be prepared and adopted by reverse merger with many changes including the change in final distribution rules. The directors would have much more latitude for legal defense. The mere fact that EZCorp has acted in such a way that I feel a need to think like this is a huge negative.
I bought in to a degree that's meaningful to me early in the Rotunda era (up and down, but generally tending toward company improvement). Since then, I have held the stock in hope that easy gestures of friendliness to the owners would let the stock price rise to an "appropriate" level. Well, there has been absolutely no break in hostility to owners, and there have been a succession of deals that net out to weakening the company.
Give us a dime a year dividend and a non-voting observer at board meetings, and watch the stock top $40 in a year. Wouldn't that be good for Mr Cohen, too?
Then I come back to the history of Incyte being above average at keeping secrets.
I may not be the only one who recalls the note issue / 2 partnerships coincidence from before.
There's also the mo-mo crowd to consider. That is a substantial group of investors who were never interested in INCY.
I just saw that they entered a partnership with Baxter to develop Pacritinib. With good study results, the drug could reach market in 2 years or a bit less.
Interesting compound said to owe all its activity to JAK-2 inhibition (although it also inhibits FLT-3). Generally good pharmacology although the 400 mg/day dose is high enough to get you to look for off-target effects (and diarrhea is reported). Very distinct structure from most disclosed Intermune compounds suggests that some patients resistant to Jakafi may be helped.
I don't think this is a threat to Jakafi's first-line status. The drug has very little anti-JAK1 activity, and Incyte results suggest that JAK1 is important in MF morbidity (feeling sick). There is no particular reason to expect one JAK2 inhibitor to be less myelosuppressive than another, so the low myelosuppression seen in early trials suggests that the drug is being under-dosed to avoid problems. In fact, a worrisome pneumonia signal is seen in early studies.
Yeah, that's roughly what I remember from the call. My best guess is that the second country should have been reported as France (which had, in fact, recently granted reimbursement). Germany would have been first. Most likely what the person on the call was thinking about for the third was The UK, where it is about time for N.I.C.E, their medical cost/value watchdog, to pronounce on the appeal of their automatic initial denial of reimbursement. Novartis had created confusion by applying to N.I.C.E. before starting the commercial rollout (That has the advantage of getting UK approval some time on the order of when other country approvals are happening.) The other theory is to go to N.I.C.E. after Germany and some smaller countries are selling, about when France is approving, to impress them with the widespread adoption of the product. Nothing works. They can sit on it as long as they like. It isn't far off the mark to say that Spain has no government. But Italy sorta functions at times.
There appear to be two TJs. One is a near-clone of V, but the other one seems to be a decent numbers guy. I pay a little attention to the latter.
Anyway, I like sending people to the ITMN corporate site because it's a rare case where you get a good look at European drug regulation. [And incidentally, a VERY promising special situation, depending on how their next clinical trial comes out] Corporate positions have spooky parallels (One marketed drug; only approved treatment for a disease that kills on a 5-year time scale, 'traditional' treatment that doesn't really work (hydroxyurea vs prednisone/NAC), early stage competitive drugs aimed at same indication, clear need for a better drug eventually, "True Believer" CEOs with public speaking problems)