I don't quite get why they are guiding lower than consensus unless consensus was way off.
I did the same recently. I have 4K shares. I think there is a reasonable chance that this gets bought out by DaVita for 1.3-1.5 billion even before FDA approval (which is imminent). Read all of the Propthink articles on seekingalpha (propthink is a good research outfit, judging by the quality of their articles). Something like Zerenex gives DaVita a huge advantage over other dialysis companies, most especially Fresenius, the world's largest. Tjhen again, it could be more interesting to Fresenius. At a $678 million market cap, KERX is an easy double, if not a triple IMHO. Zenerex is a blockbuster drug.
After following/buying this stock since $7 a share,it's refreshing to see that the CCs are now attracting 3-5 analysts. I think it's fair to say that a $40-$45 rec or two is headed our way. Keep in mind that nearly $8/share is just in cash alone, no debt, and a 15-20X PE is totally justified at this growth rate.
shoes are moving up in rank. Here is the ranking for 4-18:
2, 8, 11, 22, 26, 27, 44, 50, 61, 62, 71, 73, 80, 98
To put this in perspective, VRTX just added 6.1 BILLION to its valuation over this phase 2 trial result. In support of the previous poster, 'nuff said.
The safety data and dystrophin levels as a surrogate will be enough to get this approved. Given the small sample the FDA is of course going to crunch all available data so that they can justify to any other drug company how this went through in spite of minimal data. What data Sarepta has though seems nothing short of amazing!
March 15 top 100 CROCs postions: #5, 6, 23, 24, 29, 55, 65, 79, 82, 84, 93
April 12 top 100 CROCs positions:
#2, 8, 13, 27, 30, 34, 43, 62, 67, 69, 73, 77, 84, 87, 92, 98
Anyone get the picture? They have sales momentum.
If Kos Pharmaceuticals was able to get not one, not two, but THREE patents covering Niaspan (long-acting niacin) a few years back, then certainly KERX will get full protection for Zerenex!
I guess this clariefies the differences:
"What is different about the Breakthrough Therapy Designation is the “ … requirement of early clinical data demonstrating an unprecedented effect …”. For example, the Fast Track Designation can be granted off the back of promising preclinical data, whereas the Accelerated Approval Designation is about surrogate trial endpoints. For a Breakthrough Therapy Designation, the FDA is expected to work closely with drug sponsors to “ …. design collaborative, multidisciplinary development plans that hasten timelines to approval and minimize the number of patients exposed to less efficacious treatment or placebos"