AEZS finally broke through $.50 today. I believe the actions of $heff on IH may in part be responsible, but I also believe investors are starting to recognize that this company represents far more than one failed Phase III Trial for Perifosine.
Frankly I'm not expecting new clinical results from pivotal trials anytime soon, but Phase II's may be revealed that say a lot about trials which should be run in the future.
As for now, we should get the word shortly if the FDA will permit the rolling NDA and expedited approval requested for AEZS-130 in diagnosis of HGH deficiency. If they say yes, approval by the first half of next year is possible. Of course this is a niche drug, at least for now. All that could change if the Phase II which just began enrollment in Cancer Cachexia proves positive. Uncontrolled weight loss doesn't sound like that terrible a problem, but in reality many die of complications caused by the weight loss before the cancer can take them. There is currently no effective treatment for this condition, if AEZS-130 proves effective, even for a small percentage of patients, it could be the first approved treatment for this condition, and perhaps a niche product becomes a blockbuster. I'm uncertain when the Phase IIa Trial should be completed, but it's a double blind trial and I suspect that if positive it's data might be permitted to be incorporated into a larger registrational Phase II Trial, or perhaps they'll go directly to Phase III.
It should be early next year before we get the first peek at the MM Trial for Perifosine, it also might take that long before the Phase III Trial for AEZS-108 is initiated. All these things are taking more time than investors think they should, but all in time could lead to approval of potential blockbuster drugs.
In many ways AEZS reminds me of IMGN, lots of raw potential awaiting action. IMGN may be closer to it's first approval, but AEZS for such a tiny biotech has much to offer as well. To me pipeline is important, both these companies have substantial pipelines.
Gary |
