Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of the biopharmaceutical company Dyax Corp. (NASDAQ: DYAX) shot up by over 50% on tremendous volume today after announcing positive early stage data for DX-2930, a monoclonal antibody inhibitor of plasma kallikrein indicated as a possible treatment for hereditary angioedema, or HAE, attacks.
According to the press release, DX-2930 was well-tolerated at all dose levels, exhibited clear-cut dose-dependent pharmacokinetic activity, and, most importantly, significantly reduced the rate of HAE events at both the 300 mg and 400 mg doses.
Topping it off, Dyax announced that the Food and Drug Administration granted the experimental therapy Fast Track designation.
So what: Dyax was previously able to convince the FDA to bestow orphan drug status on DX-2930 for this rare and serious disease. As such, the company should be able to command a premium pricing structure -- along with all the other benefits orphan drug status comes with, such as extended exclusivity and tax incentives -- for DX-2930 if it is able to gain regulatory approval down the road. In short, this experimental drug could be a major value driver for this mid-cap drugmaker at some point.
Now what: Dyax is now expected to push the drug into a larger mid-stage trial that could serve as the basis for a regulatory filing, especially after receiving Fast Track status from the FDA today. Based on how quickly these first two clinical trials have progressed, the company could conceivably have the drug under regulatory review by either late 2016 or early 2017 -- just as long as it continues to exhibit a strong clinical profile going forward.
Looking ahead, investors should probably brace themselves for a secondary offering that will be used to cover the costs of the drug's future clinical development. After all, that's fairly standard practice in the industry for smaller companies following a positive clinical or regulatory event. However, that's also why you shouldn't chase this high-flying stock in the immediate aftermath of this news.
