Certainly market momentum is in favor of Oncothyreon. Onty stock price is up 3X since ASCO and PBYI is down to 1/3rd (roughly). I think you have to own both and believe that big pharma will eventually own both. Let's make our T-chart comparison. In favor of neratinib 1) definite clinical benefit and further along in phase 2 study, meaning potential first to market; 2) irreversible covalent bond to HER site affecting kinase modulation, thought to be less subject to mutation/resistance. As for ONT-380, relative benefits appear to be 1) effective in patients refractory to both neratinib and herceptin 2) apparent superior CNS benefit as demonstrated in brain lesion resection in surviving human patient demonstating tissue necrosis at lesion site. This potential benefit is now in further study at Dana Farber and may be the route to expedited approval to leapfrog neratinib; and 3) 380 is specific to HER2 site and largely avoids EGFR problems of diarrhea and skin rash. Naysayers claim this can be addressed with prophylactic symptomatic treatment - but why go this route if cleaner HER2 inhibition is possible?
Of course the answer is in a comparison study, and it may be possible that a protracted course of therapy might involve both molecules. (ONTY-380 alone, then with a cytotoxin, then neratinib alone and with a cytotoxin, ie Tykerb approach)
This is all in my opinion of course - now for wild speculation- Oncothryeon mentioned at ASCO that another ONTY product line - protocell - had generated lots of interest for collaborative study in the very hot CART space and that a likely partnership would be announced "very soon" after ASCO, which would fund further study of 380. This has not happened yet, fueling my belief that a larger partnership is imminent..
Last point - Oncothyreon's third potential product line iis ONT-10, now in study with Celldex's varlilumab. Kind of a freebee in the ONTY investment story.
Have a good weekend as well.
As an aside, don't forget that Puma has loosely guided to publishing the ExteNET results (initially released at ASCO) in a scientific journal in August as well. Tough to imagine that, in and of itself, such narrative will be massively price-impactful, but if it's the right publication with the right scientific argument (ideally known thought/opinion leaders), it could be another positive that few, if any, seem to be discussing right now. A bit of a free call option on the story, if you will, as it's hard to imagine such an article would be a negative for the common.
As always, time will tell. August should be interesting. Let's see if the 'cover doorway' gets crowded as shorts lose their manners and push to run through it simultaneously as FB-7, etc. get closer and closer to release.
got it. Ok Great. Thanks for the information and how to navigate the site. Appreciate it. !! Have a good weekend.
Well said. Excellent summary. It is obvious that this drug will be a winner. Some diarrhea is better than some lasting cancer. Thanks for your insights and excellent summary. Did you see this after hours quote on PBYI?? Any clue.? I am hoping it is meaningless. Stock finally went up, then come home to see a quote of 83 bucks afterhours, down like 7%???
ONTY is the real deal better safety profile better drug ... I can provide more details ...do some DD and check it out for yourself ... Good luck investing .....
I researched all 42 trials, old trials and on-going trials (Directly from the official CLINICAL TRIALS WEBSITE): there is NO NEW DATA to report, positive or negative regarding Neratinib. Yahoo BID 90.44 ASK 90.60.
Scottrade has the usual big spread afterhours: BID 80, ASK 115. Absolutely normal. For example BIDU:
Bid 137 Ask 172. Current stock price: 172.
Yes, I did see it myself. Don't take my word for it. Look for yourself.
Go to clinicaltrials.gov and type in "NSABP FB-7" or something similar to track the status of this P2 Neratinib trial. The government's site search function will quickly pull up the trial, which is also identified as "NCT01008150". Click on the underlined blue text that captures the trials formal and more descriptive name. It will take you to a body of text detailing the study and general protocols.
Scroll down about 1/2 of a page and you'll see the new "Estimate Primary Completion Date:" tucked in the text directly under "Secondary Outcome Measures". It reads, "August 2015 (Final data collection date for primary outcome measure)". That date was just updated in July.
The very long-awaited NSABP FB-7 readout appears to be nearly here, and we will see if it confirms I-SPY's findings, which for those following closely had a funky Bayesian structure (Neratinib performed well and graduated to a P3 in that study.)
IfFB-7 comes through positive on both accounts (safety and a nice combination beat with triplet arm, in particular), the shorts could be in for a massive, brutal squeeze. That is my opinion.
Good luck to all who do honest due diligence and don't traffic in, or create, rumors and mindless bulletin board pablum. Not a fan of those making up things or using childish hyperbole, like talk of poopy pants, with respect to safety and toxicity of molecules. This and like drugs that have the potential to change lives. Side effects are not a punchline.
Time will tell if they will or not, but I choose to focus on facts and logic. August could/should be very interesting for PBYI.
is it possible that this afterhours figure is innacurate? I have sometimes seen afterhours quotes with a technical error in that the amount UP today is almost identical to the amount DOWN. Could be a mistake.
Did you see clinical trials.gov update? Thanks for the insight......
Yep. That could mean we get topline results as early as next week, but very likely in the next handful. If the safety profile looks good on the triplet arm (Taxol/Hereptin/Neratinib, which was reportedly 100% prophy'd with loperamide) and the combination repeats, readout-wise, what we learned in I-SPY, the shorts could get their faces ripped off. My hunch is a few of them tried to tip toe to the door but drew too much attention. Nearly 1 million shares today. Monday may be the second act.
I like the stock at deep on sale price 80 yesterday
hope the stock heading back retesting the 250 level
Hold it for a considerable period of time and you will be glad to park your money here. Believe me, it is far better parking money here than putting them on hot stocks chasing tumor immunotherapy.
+10 point gain from yesterday's low 80 (now 90)
gotta love the biotech rally from bottom = green $$$
A new phenomenon is a combination of a few hired medical key opinion leaders, biotech social media (like Adams F. ), law firms and groups of hedge funds/high frequent traders that are coordinated to terrorize investors. The bottom line reiterated here: Neratinib is an irreversible, Her2 inhibitor, whose efficacy was shown to be efficacious in prolonging iDFS (p value, 0.009) by reducing the relative risk by 37% (another HER2 reversible inhibitor, Lapitinib failed); Neratinib reduces significantly the incidence of brain meta (Her2 ab not); Neratinib is the most effective inhibitor for activating mutated Her2; in sub populations of breast cancer patients, the benefit of Neratinib is more remarkable. The safety issue: diarrhea, that usually occurs only during the first month of the treatment; with proactive prophylactic treatments, the incidence of grade 3 reduces to less than 17%. So, Neratinib will bring the benefit the currently marketed drug can not offer; Neratinib will be approved. The peak sale of this drug is anyone's guess, but given Neratinib can bring the benefit others can not, it is easy to reach the north of 1 bn sale; Puma should be a 5 to 6 bn company.
Awesome explanation. I glad someone understands the hazard ratio, and so forth. Very well said. You understand this field like I know tennis, which I have been doing for 40 years. Thanks so much for all the great information, and analysis. I look forward to hearing anything informative or educational about this company and drug....... Appreciate it..