|Stock up 4 dollars or 30% in the last week. The market is fundamentally revaluing us higher. Not sure where this will peak, I'm surprised by the strength of the move. Leads to the obvious question, what has changed in the last 7 days? I see four factors, the most important likely was the Daiichi data showing that their trop 2 ADC appears to have significant toxicity issues, and that progress on that product is going to be much slower than an all-out sprint which was possible given its initial excellent results. Second, Behzad reiterated we will be filing early fourth quarter. Given that is now 30 days away, it is unlikely that any significant material issues need to be fixed, it should be mostly getting the paperwork in order. Third, getting the late breaker poster for bladder cancer, which also put the possibility of BTD and potentially even AA back in play for bladder. Finally, we got more clarity on the timeline for ASCENT, and Behzad seems to reassure us that the FDA will not use an imminent ASCENT readout as a reason to not act on AA. |
Once we file for BLA in October, and we get acceptance of the application 30 days later, we will be back to where we were last summer when the stock hit 27. The difference is that this time we no longer have risk of failure of AA on efficacy issues, and we have had 9 months to fix our CMC, which should in any normal world, be fixed. This is the execution factor, and I have been skeptical of B on the execution side over the summer. Given the other risks that were hanging over us, I advocated selling the company (at roughly 25-30 PPS). Given the events of the last week, I think we have derisked significantly, and I am now comfortable holding into January. If the bladder data allows us to get BTD, that would derisk us even more.
Given that we are better positioned now than we were last August (assuming BLA is filed and accepted), then shouldnt the stock price reflect that? Would that not argue for us getting a PPS over 30 after the BLA is accepted? The analysts remain rather bulllish with price targets of 20-40 dollars, and as the Twins keep pointing out, institutions have remained invested (although Fidelity has come and gone and come and gone at various times). The biotech sector as a whole though sold off last year and has never really recovered, at least on the spec company side of things, and that may hold us back. But it is conceivable the stock price could react similar to last summer once we get acceptance of our BLA.