Biotech is getting hit for reasons that don't relate to ISIS, but ISIS gets hit right along with them, for now. Biotechs have conducted a tremendous number of secondaries and several of the raises have been followed by negative trial results. This is making investors jittery for the moment on early stage biotechs. Yet, ISIS has reported extremely favorable clinical data, picked up the Bayer deal, and doesn't need cash, but it gets caught up in the swoon anyway. Won't last, but have to go with the flow in the meantime.
They also noted that they believe the data already available is sufficient to support FDA clearance for an indication in infants and children where death is the only alternative. I am from the industry and would agree, as the FDA is quick to help infants and children with no alternative treatments available. Separately, another analyst has noted that an early approval was worth $11 to $12 per share atop her $78 price target.
Sentiment: Strong Buy
Actually, this would be a perfect candidate for the FDA to move early. There are no alternative treatments. We're dealing with infants and in relatively small numbers, so a post-market study could be practical to pursue (continuing to provide data after going to market). And, there are no apparent severe side-effects with tremendous apparent benefits.
Very nice progress. Not only is the therapy halting the deterioration caused by the disease, but it is allowing the babies to make progress and without substantive safety issues. Very impressive indeed.
The Bayer deal and Boston Children's data IMO dramatically increase the value of the company, yet the stock is trading 10 - 20% lower than it was 3 months ago and about exactly where it was trading leading up the Bayer announcement. Hopefully, these positive milestone achievements put a floor under the stock somewhere near these levels and create the opportunity for a nice climb in the coming weeks and months. Personally, I think this is a very high potential opportunity that will take some time to unfold, but the latest announcements give me quite a lot of confidence that it will and the stock won't be anywhere near these levels if and when it does. GLTA
Sentiment: Strong Buy
This was my first exposure to the CEO and I found it truly bizarre. There was so much positive he could have said. Why didn't he just talk about what P2 was showing with regards to safety and tolerance (which is the intent of the trial), how encouraging and exciting the results are to date, and leave it at that? Why hammer the idea home that "nothing has been proven," over and over again? Even when Kramer set him up with a softball leading him to talk about the death rate and ventilation rate of patients with the ISIS treatment v. what would be expected without it, he acted like a 50% death or ventilation at 6 to 10 months without the ISIS therapy v. 0% rate with it was no big deal and again concluded by saying "nothing has been proven." It was a pathetic showing and his IR people need to prepare him better in the future, or keep him out of such venues.
I respectfully disagree. While there is no doubt that a phase ii safety trial without a control group doesn't prove anything, the CEO was a complete buffoon. Of all the positive results to highlight, the only thing he could seem to focus on was that the trial "doesn't prove anything." Even Kramer tried to help him out by asking what could be expected without the treatment and he acted like it was no big deal that a 50% rate of mortality or ventilator support at 6 to 10 months v. the results wasn't that big of a deal (when it certainly is). As a new shareholder and a former medical company CEO, this was my first exposure to the CEO and I was very disappointed. It was very much amateur night from an investor relations standpoint. If he had nothing better to say, he should have declined the invitation.
Personally, I am a serious investor who was CEO of a public medical company for 17 years. I am up more than a half million on ISIS in recent weeks. Yet, I was disappointed in the CEO's performance tonight on MM. And frankly, if you knew how ridiculous you sound complaining about a company that you admittedly watched go from $7 to $70, you might find something more productive to do with your time.
Thanks, but Vical is of no interest to me. IMO, ISIS is going to be an enormous success in the coming years. I just wish he CEO were more investment community savvy because it would make life for shareholders a bit less volatile and easier.
Can someone tell me why the CEO went on MM for no apparent reason other than to hammer home the idea that nothing about the data released this morning proved anything? I am a recent shareholder sub-$57 when the market reacted negatively to what I viewed as an exceedingly positive development with Bayer, but it does concern me that the CEO (while perhaps scientifically astute) appears clueless when it comes to supporting shareholder interests.
The significance would seem to be the validation of the underlying technology, rather than this one application, so the implications are broader. Piggy backing on the Bayer deal, I would think the large number of shorts in this stock would be wanting to get out of their positions which could drive ISIS stock price back to, or above, its recent highs. Personally, I bought sub-$57 after the Bayer deal was announced and the stock reaction was surprisingly negative. I trade around my position, but believe this stock has legs for quite some time to come, if the data keeps coming in positive which every data point gives us more cause for confidence in the next. GLTA