Why Lexicon Pharmaceuticals Fast-Tracked Higher
Dec 17th 2012 2:32PM
Updated Dec 17th 2012 2:46PM
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 biopharmaceutical company Lexicon Pharmaceuticals jumped as much as 12% following an announcement from the company that its experimental irritable bowel syndrome drug, LX1033, has received fast-track status from the Food and Drug Administration.
So what: The good news here is that fast-track status has two key components that every shareholder should like. First, as you might expect by the name, it helps to speed up the review process because the FDA feels IBS-d (diarrhea-predominant irritable bowel syndrome) is a disease with largely unmet clinical needs. Second, it allows the FDA and Lexicon to work side by side with regular meetings so there are few (if any) delays in understanding what sort of efficacy, safety, and manufacturing qualities the FDA is looking for in its review process.
Now what: Before you go running to your computer to click the buy button, consider that fast-track status doesn't mean LX1033 will be approved, either -- it merely means there's a need for treatments for IBS-d. LX1033 is currently in mid-stage trials, and Lexicon is expected to report data from that trial sometime in the first half of 2013. In early-stage trials of LX1033, it demonstrated significantly reduced serotonin synthesis levels at various dosing levels and exhibited a good safety profile. Now, we patiently wait for LX1033's mid-stage data and get primed for late-stage data hopefully sometime next year on its carcinoid syndrome drug, telotristat etiprate.
Craving more input? Start by adding Lexicon Pharmaceuticals to your free and personalized watchlist so you can keep up on the latest news with the company.
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