) -- This week's Biotech Stock Mailbag opens with a question from Jeff N. "Adam, I wanted to get your feedback on your prediction for a takeout of
Whoa, slow down, Jeff. Let's not set the bar for YM Bio at an unattainable height. Investors are anxious enough already over the interminable wait for YM Bio to negotiate a partnership for the myelofibrosis drug CYT387.
On the partner front, YM Bio CEO Nick Glover says the company continues to "conduct a robust business development campaign aimed at exploring potential opportunities to further develop and commercialize the drug with other companies ..."
Oy, that's painful to read.
Chatterboxes hanging around the biotech water cooler speculate that YM Bio is in serious partner negotiations, and the delayed start of a phase III study of CYT387 may actually be a signal of an imminent deal because potential partners want a say in the final design of that study (or studies).
YM Bio's guidance for the CYT387 phase III start has been a moving target (first, summer 2012, then second half 2012) that's now vanished. On its latest quarterly update issued Sept. 21, discussion of the phase III start was conspicuously absent. (Hence, the speculation about a deal.)
It's entirely possible the opposite is true and YM Bio is nowhere close to finding a partner for CYT387. Investors won't be happy if the company goes solo into phase III. YM Bio has enough cash to run a phase III study on its own but the stock will benefit greatly from the validation that comes from a partnership.
The idea that potential partners want input into the design of the CYT387 phase III studies is plausible given the different options on the table. The lowest-risk study YM Bio could run would be to compare CYT387 against placebo/best supportive care. This is the same trial design used by
(INCY - Get Report)
to get Jakafi approved in myelofibrosis. But with Jakafi approved in the U.S. and Europe, will doctors and patients want to participate?
The riskiest study design -- but also the one with the biggest jackpot if successful -- would be to run a head-to-head study of CYT387 against Jakafi. Personally, I'm rooting for this option. If YM Bio believes CYT387 is the superior myelofibrosis drug, then why not prove it definitively? High risk but high reward.