Gilead is publicizing their ASCO abstract on idelalisib in CLL, which put up some strong numbers. Keep in mind, however, that Dr. Jennifer Brown, who ran the study, is on a short video mentioning the promise of ibrutinib and idelalisib in CLL from last month, but seeming to be somewhat more enthusiastic about ibrutinib.
Net: Don't get spooked if Cramer or some other tout talks up idelalisib to the detriment of PCYC.
In Forbes today it was said that idelalisib was promising but bigger studies will be needed.Also It’s too soon to tell how this drug compares to another important CLL drug, ibrutinib from Pharmacyclics and Johnson & Johnson.
Sentiment: Strong Buy
A couple of other things to note:
1) GILD combined their drug with rituximab in treatment-naive patients. The bulk of data on ibrutinib is as a single agent and/or in patients with less favorable initial presentations (previously treated, high-risk, etc.).
2) The mechanism of action of GILD's drug is different--there would likely be space for both of these agents in the management of CLL and other malignancies.
Yes, you are obviously familiar with the issues. Note, however, that GILD has a number of Phase I abstracts in ASCO on idelalisib in refractory patients. And you're right, the success of one drug doesn't preclude the success of the other. However, keep in mind that most people are lazy and have no willingness to understand these issues beyond "The stock is going up." or "The stock is going down." Have a plan.
Yes, and ibrutinib has 3 separate "breakthrough therapy" designations from the FDA. The Phase III studies for idelalisib are just in the announcement/enrolling stage. I agree that they're more than a year behind PCYC. But keep in mind, a lot of people own this stock without having the slightest notion of what the products/opportunities/time horizons are. Have a plan. It would be funny if GILD (which I also own) advances on this news, since it is really of minimal importance to them. The first PCYC approvals should be for MCL, for which there are no other viable alternatives, then Waldenstrom's, I think. The mills of the FDA grind slowly, but they grind exceeding fine.
Cramer is already out on The Street identifying idelalisib as "a competitor for ibrutinib" and citing some numbers from the phase I study of treatment-naïve CLL patients. Frankly, the results of the ibrutinib study on similar patients look much stronger to me. The most impressive thing about ibrutinib in CLL is that it seems to clear malignant cells from the lymph nodes, spleen, and bone marrow. I see nothing in the GILD results which seems to match this level of effectiveness. But no doubt some may sell PCYC tomorrow. The last time Cramer issued this kind of alarmist stuff - saying that the approval of ONXX's multiple myeloma drug would hurt Celgene's Revlimid - he drove the price of CELG down by 8 bucks and created a great buying opportunity. Actually, the two drugs didn't compete. This shows how superficial the level of research The Street provides in this area.