As a close follower of the hematologic cancer developers, I wanted to point out the following important data releases that are scheduled for the upcoming 55th annual American Society of Hematology Meeting - to be held December 7-10, 2013 in New Orleans.
Iclusig Analysis - ARIAD Pharmaceuticals (Nasdaq: ARIA)
ARIAD Pharmaceuticals is a late stage cancer drug developer that is currently trading at a market cap of $462 M, which is the result of a YTD loss of 87%. When the company was worth over $3 B (just a few weeks ago), the valuation of the company was primarily based on a cancer drug Iclusig (ponatinib) which was approved by the FDA for the use in two blood cancer indications - CML, and Ph+ ALL.
Investors remain terrified of any exposure to the blood cancer drug ponatinib after the disastrous safety result of the PACE trial and the subsequent suspension of US marketing rights by the FDA. While the drug is in very hot water due to its association with increased risk of blood clotting, the company will be presenting some data at ASH that could help us clarify the risk/reward of ponatinib and possibly offer a chance at salvation for ARIAD Pharmaceuticals.
In particular, we may want to pay attention to a presentation that will discuss the clinical implications of ponatinib dose reduction and/or interruption. A Phase II trial showed that there is a direct correlation between dosage and cancer response rates, although benefit was shown at lower doses as well. This presentation will occur on the evening of Monday, December 9th.
The company is well financed, and may try ponatinib for the currently approved indications at a lower dose. Also note that it is undergoing development for a number of similar blood cancer indications, and the company will be presenting data from those programs as well. This may explain why certain funds, like Sarissa, have been accumulating the stock after the big plunge.
Abstract links: (link)
SL-401 + Preclinical Updates - Stemline Therapeutics (Nasdaq: STML)
Stemline is a company that held its IPO earlier in the year. Even after an exaggerated pullback throughout the last few weeks, the stock is up 78% since IPO because of the value of its pipeline. The new valuation of the company is $271 M, which is appropriate for a cancer drug developer with Stemline's financial and pipeline assets.
One of the merits of the company is its diversification relative to its size. Although there are only two official drug candidates at this point (SL-401 and SL-701), there are four mature programs here that are getting close to pivotal trial registration.
At ASH, the company will be have five separate presentations. The most important of these will be a clinical update for SL-401, which will provide some details on the exceptional early activity that the drug therapy has shown against a rare blood cancer known as blastic plasmacytoid dendritic cell neoplasm (BPDCN). Up to this point, the drug has delivered an 86% overall response rate and a 71% complete response rate for this indication, which is truly exciting. The sample size was small (7) for BPDCN, although more data is coming.
The other presentations may be interesting, but they are less likely to have an effect on the stock price since they will discuss preclinical data. Perhaps the most exciting of these preclinical data presentations will be the presentation for SL-101 - an antibody-drug conjugate being specifically developed for AML patients with the FLT3/ITD mutation.
Abstract links: (link)
Implications: These pharmaceutical stocks may see some activity after these events due to the importance that this upcoming data may have on their future prospects. Since both companies have been poor performers in recent weeks, the bias may be towards the upside given that the companies have something good to say at ASH. However, either the long or short side of ARIA and STML hold significant risk for anyone trading. Investor due diligence and caution is, as always, advised.