The absence of commentary suggests that the poster didn't go beyond its abstract (fuller presentation of the trial design than given on Clinicaltrials). This is the smallest possible quantum of good news for Imetelstat because that was always by far the most likely poster, and if dosages were being increased (good safety / tolerability) the decision would not have been made yet, while the reverse could have been decided by now (you respond faster to sicker-than-expected patients than to healthier-than-expected ones).
CC coming up, and this is an anniversary of "The Bad Conference Call." Two special features this year: exaggerated "Show me the money" investment focus and a very threatening political season. Incyte is responding by becoming more closed-mouthed. As I've said before, this increases "event risk" to the stock price (it DOES save a lot of resources on the 355 days of the year when nothing much is new).
So in general, there isn't much chance of NEW news, and essentially no chance of "6-month-cash" news. Since the study centered on 50465 (the delta drug) is open label, there may be updates from it. The need for a safe delta drug is great, so something might be said about seeking accelerated approval. That's the only own/own combination I can see being of interest to investors now. I'd love initiation of a trial of '110 against some sort of alopecia, and safety data might permit it, but it won't happen. Something related to ruxo + low dose interferon in MF might actually move the stock, but there's SOMETHING blocking IFN in the US (I'd appreciate a story)
So the interesting things are Jaka[fv]i revenues, clinical trials budget and the remaining Novartis milestones. I expect another instance of near 60% YoY J..i revenue growth, driven by technically off-label expansion in PV (pts who have chart, but not health, improvement with HU), MF (lower risk active cases) and GVHD. This rate of growth can't continue forever, but this Q would be a particularly bad time [for us] for it to level off. 59% YoY might be acceptable, but I'd expect widespread disappointment with 57%. The phase 3 program won't change, and the big expansion of the phase 2 program was last year. So the big uncertainty is whether the "maybe" on atopic dermatitis is resolved. If Lilly goes with it, I'd expect Incyte to also, but the decision is still probably 6 mo off. Milestones? No reason to expect news.
Fittingly, HH gave a longer term look than RH. Central message was that Incyte should do just fine with ruxo and bari for as long as necessary, but the mid-maturity pipeline (something like '110, capmatinib, epac, the delta candidate and maybe the EGFR candidate ought to generate a flurry of approvals in the '19-'22 span. Apparently, the ones useful only in combinations may need separate approval for each combination. Cross-modal combinations (say an infusion and a tablet) where neither agent has a good case for approval without the other are unfamiliar regulatory ground, and there may be some of those.
I admit amusement that HH characterized PV rather than MF as the largest Jakafi opportunity (with GVHD trailing and nothing serious about hair growth yet). You could look it up: I was saying that in '424 days The other half of that is that Jakafi is priced too high to take maximum advantage of the PV market. So sooner or later, expect a price drop or at least some skipped price hikes. Every reason to time and promote these for maximum political benefit.
More of me rather than HH talking--he DID say that Lilly are telling him bari approval in '17. The more I think about it, the more I expect an advisory panel first. It stands to reason that with the supporting data, Lilly would be proposing a label that displaces MTX entirely, and maybe more. A positive recommendation (even with less than the requested breadth) would make a fine Christmas present (approval in late Q1).
Phase 2 extension of a Novartis phase 1/2 trial against NSCLC in salvage mode:
The most common AEs (regardless of causality) were hypoalbuminemia (29%), peripheral edema (27%), and decreased appetite (23%). The most common Grade 3/4 AE (regardless of causality) was increased amylase (7%). Partial responses (PRs) were seen in 12/65 evaluable pts (ORR 18%) and 40/65 (62%) pts had stable disease (SD); disease control rate [PR + SD] 80%. 10/53 pts with IHC 3+ or IHC 2+ and GCN ≥ 5 had PRs (ORR 19%) and 7/23 pts with GCN ≥ 6 had PRs (ORR 30%). Conclusions: INC280 400 mg BID + gefitinib is well-tolerated and shows encouraging clinical activity in EGFR TKI-resistant NSCLC pts, particularly in pts with high cMET GCN. Clinical trial information: NCT01610336
This would usually be considered good enough to justify further study (depending on their internal evaluation of the patient group, possibly enough to generate some urgency). If I recall right,
Novartis's schedule looks forward to introduction of this entity as a drug 2019 or 2020.
It appears to be a small shop. They have one reasonably bright guy on staff ("Good TJ") and a perhaps 3 posting typers (I think DRIP may represent a new writer. 15...14...13 may be gone or may be on another project). The temporary friendliness to Incyte may have been pique at being left out of last Fall's bear raid. I suspect that Yahoo has done something to inhibit 20 posts in 10 minutes.
But these guys aren't class. To support a bear raid you buy recognized sources and take floor traders to lunch. These guys just function to keep real information (which for Incyte is generally favorable) moving to the back of the book in the message board. Bickering with them, even in non-replies, does their job too. To see the height of information concealment, look at the Geron board (much more traffic with much less information)
If you haven't read it yet, look up the old Seeking Alpha article "Inside the Boiler Room," although that covers a larger operation (and focused on a pump rather than a bash).
That smarted. But looking back, I see Incyte has been making higher highs and higher lows for the last 4 months. That sort of thing tends to be a bit self-reinforcing. Whatever. We're in for 4 months of politics dominating everything. The only thing I can see in that with more than a brief effect would be a clear sign that Elizabeth Warren will or will not be errr "messing with" the drug industry. If she's VP or Treasury Secretary she'll be distracted. If she's Commerce Secretary, she might easily get involved. I don't think she'd take HHS. And if she's still in the Senate, all bets are off. (If Trump wins, I put most of my investable funds into canned food, but that's just me).
Motley Fool had something about Agenus yesterday. Piece projected a need for [presumably dilutive] financing around EoY. Curiously, that's also estimated timing for bari approval milestone payments from Lilly to Incyte. If ongoing trials look good, Incyte might buy more. The theory has always been that for development of biologic / small molecule drug pairs, any on-target biologic is good in the early stages. And contrariwise, for a developmental biologic, early stage trials as part of a combo can pay for what would otherwise be substantial nuisance expenses.
For all the Brexit-related talk about European bureaucracy, EMA may well approve bari a bit before FDA. EMA "showed their work" on Xeljanz, and protection of joint structure was most of the story. Lilly made sure that was well-addressed in trials.
Interesting MarketWatch article dated 6/20. Looks like drug pricing is going to figure in the Presidential election no matter what, because Trump thinks it can broaden his appeal, and frankly, Hillary is a bit scared to touch it after the reaction to her Turing tweet.
ANYway, there's a suggestion in the article which might get us most of the benefit of UK's N.I.C.E. without the rigidity (which would hurt worse in the US than it does Over There, 'cause we don't have such a tradition of changing laws on-the-fly). A government agency might require cost::effectiveness reviews of selected already-approved [classes of?] drugs. It offers a hope of stopping the present trend for newest drugs to explore unheard-of price territory without intolerably disrupting markets.
Something MUST give. The politics of hepatitis C could get unlimitedly bad (many, maybe most cases were a result of treatment of war wounds but VA can't afford CURATIVE drugs for all; by limiting number of cases cured, an outbreak that could be ended in a year or two can be stretched for decades).
Trump's said to favor allowing re-importation of drugs sold overseas, and to want to free Mdiacare to negotiate drug prices any way they choose. Hillary is thought to favor something much closer to N.I.C.E. (Whose main tool is "You can't sell it for that price. Come back cheaper and we'll reconsider--from the beginning).
A few quick observations:
For epac, not only did the melanoma trial start first, the disease is more homogeneous than most of the others being studied and the baseline response to the underlying immunotherapy is better-characterized. So that's part of why other results are slow appearing.
Not explicit, but the answer to a question about the Comfort follow-up suggests considerable resistance to use of Jakafi in intermediate-risk MF. Potential for a lot more market penetration.
Comment about interest in non-oncology treatments brings bari back in from the cold. and suggests that maybe the inflammation-directed JAK 1 program might be returning.
First justification I've heard for the FGFR drug program: aiming at higher selectivity than existing agents.
They tell me that there are at least 15MM people US/Eur who objectively have RA but aren't affected greatly enough to show up in this argument so far. I don't think it changes anything. It's amusing that the price range of INCY seems to reflect belief in an approval that will generate roughly the level of revenues guessed at here, at a time now [just] within investing horizons, but the sell-siders are hardly talking about it.
I could be Sleepy, too.
This may save a meaningful amount of money as Incyte brings GVHD on-label for ruxo. I don't know the reimbursement landscape for off-label use, but that ought to improve also. I think a large fraction of the sales possible for this indication are not waiting for the label expansion, though, so The direct benefit of accelerated approval is modest.
The second-order benefits are unpredictable, and may be larger. It'll take at least until the p3 finishes for those to show clearly, because they are likely to involve more cautious oncologists. With improved prognosis for GVHD, more procedures that carry a risk of causing it will be done (particularly mixed autologous / heterologous stem cell transplants--I've said why I'm an avid spectator of myeloma developments, and mixed transplants have a large AVERAGE benefit there, but are limited because the worst case outcome is so bad). Other procedures that have a risk of causing marrow failure will look more attractive as rescue by transplant becomes less desperate.
Up there with the stupidest things you've ever said.
1) Myriad DID used to do cancer drug discovery / development. The business was too different from tests.
2) EndoPredicet IS integral to the mission.
TMF ang4apples recently did a comprise of Incyte with Amylam. He didn't repeat any of the popular lies about ruxolitiib, and he gave a realistic number for potential impact of baricitinib. He tried to poke at the edge of the epac prospect; a single paragraph there is inevitably unenlightening, but he didn't get lost in it, and it can stand as a signpost marking the whole 'attractive nuisance' of drug couples.
It bothered me that Novartis said they had initiated further phase 2 studies, but nothing showed in clinicaltrials. I had thought that anyone doing business in the US had to post on clinicaltrials for all drugs and most medical devices before treating the first subject in a trial. Turns out, it's a lot more complicated. I'd welcome informed comments. After about 1 1/2 hours of poking around by this non-lawyer, it appears that a trial on a not-yet-approved drug, receiving no federal funding, and not enrolling subjects in the US can comply with the relevant law by posting to clinicaltrials promptly after study completion.
Well, that answers the old question about how Myriad will bring EndoPredict selling into the US.
I actually know more people who have died from over-treatment of cancer than from the cancer itself, so reliable prognostic tests are A Big Deal.
Since the kit platform is a key to Myriad's future, I view the loading of the upcoming instruments with a significant-volume test as more important than earnings from the lead test.
I think the merger CC was the first presentation of the commerce model underlying the kit tests. Interpretation will be kept centralized as essentially a web service.
Barron's just addressed this for the whole industry. They see political "cooling-off" and a bit of M&A. Fundamentals are affecting individual stocks, with a chance that anyone's unexpected blockbuster could lift the whole sector. They seem to attribute much 2015 strength to unexpected money in Hep C. [Since (according to me) Hep C pricing is untenable long-term nationally, and the crunch will come through politics, there's "a challenge" waiting down the road]
Clock on Myriad's database is ticking pretty loudly. The social-media-savvy Metastatic Breast Cancer (MBC) project is collecting everything they can get, including full genetic sequences from saliva and tumor specimens, from "metsers." (metastatic breast cancer patients). Doesn't really change the expected time before non-Myriad databases become clinically useful (still probably 2019), but gives a visible example of a project collecting the information needed to do such a thing, working now, and with resources to finish the job. Probably take longer for "free information" based tests to become competitive on prognosis or treatment selection because those depend on following patients aggressively; voluntary participation is unlikely to be able to overcome "missing data" prolems.
Presented at ASCO.
It was frustrating when N.I.C.E. gave the narrowest justifiable approval to sale of Jakavi. But with a couple years of limited English sales as a result of that, it partially insulates Incyte from Brexit (and I DO believe Britain is headed for the big exit--Scottish devolution soon, possibly with a less-than-friendly border; Northern Ireland next.) (Welsh participation in The UK has always been something you see if you look one way, and don't see if you look another)
N.I.C.E. is going to have to change substantially to replace the overall approval function of EMA. Probably going to be delays for everything. Unfortunately, bari has very much the profile of a drug most likely to be hurt by the changeover (The case for it is SO strong that EMA might even beat FDA to approval; cost effectiveness likely to get it through N.I.C.E's existing functions quickly--even if it's the first thing English FDA approves, that's likely to be a few months of delay).
He mentioned it in the SA article. He considers it a long-term threat to the business of Jakafi for MF.
As for what actually happened in the Mayo Clinic demonstration series, you should read the full report in the Sept 3, 2015 issue of The New England Journal of Medicine, preferably along with the on-line appendix. (Many hospitals have back issues of NEJM available; I went to a university library to get the appendix. Tefferi ought to send you an offprint if you contact him.). A drug with the properties shown in the NEJM article (7 patients of 33 responded at all; there were more adverse events of grade 3 and 4 than total patients treated) would never be tried until after Jakafi had been tried and failed (that is, in fact, the subject population for the Janssen study).
There have been 5-year follow-ups published recently on the 2 phase 3 clinical trials of ruxolitinib as treatment for MF. They're quite favorable; in particular, patients with intermediate-2 MF at time of enrollment have median survival more than twice as long as with placebo or prior best available treatment.
There was an attempt in the NJM paper to confirm the proposed (anti-telomerase) mode of action of the drug. The Editors (M. Armanios and CW Greider) commented that it left other possibilities for mode of action open. What works, works, however it works, but in predicting generality and duration of activity, the mode of action is guidance. Anti-telomerase activity leads to more favorable predictions than most other possibilities.
Most likely extended report on phase 1/2 of epac + pembo vs multiple tumor types. What we've heard about is longer follow-up on the same subjects from last SITC. I'm guessing a journal publication. "Other" PD-axis drugs + epac probably not until this year SITC.
Trial of a combination of ruxo with low dose interferon could come any time. I don't know the politics here, but on a purely med-sci basis, this would have happened months ago.
Also in the investing time frame, there may be an announcement related to that S,N oligonucleotide. A planned safety/tolerability review has perhaps 1 chance in 3 of causing the dosages being tested to be changed. Change would be announced; no change won't be.
There may be surprises, but so far the most enduring result for Incyte looks likely to be the push toward using Jakafi in lower risk cases of MF. This gets into a complex interplay of evidence (The Comforts indicate pretty strongly that earlier treatment helps patients substantially, but they weren't designed for that purpose), medical practice and payer agreement. The addressable market for Jakafi could increase 10-25%, but push-back on reimbursement might easily make the money gain smaller than that.
The Minnesnowta Ethiopian will be speaking. His remarks tend to get press coverage, but it's too early in the formal trial of the drug he likes for it to mean much.