Why Lexicon Pharmaceuticals' Stock Gained Over 50% Today

What: Shares of Lexicon Pharamceuticals skyrocketed by over 50% today on massive volume after the tiny biopharma announced that theexperimental drug, oral telotristat etiprate, met its primary endpoint in a pivotal late-stage trial of lowering the average number ofdaily bowel movements in cancer patients withcarcinoid syndrome not adequately controlled by the current standard of care. Carcinoid syndrome is a rare disorder affecting patients with neuroendocrine tumors, causing patients to experience severe bouts of diarrhea.

So what:Since its inception, Lexicon has seen numerous clinical products flame out. Today's news marks the struggling biopharma's first late-stage clinical success of any kind, and potentially the turning point in the company's operating history.

Now what: Following these positive top-line results, Lexicon plans on filing oral telotristat etiprate's regulatory application for this indicationwith the U.S. Food and Drug Administration in the near future. Given that the drug was previously granted Fast Track designation by the FDA, it could be on the market as soon as the first-half of 2016, assuming approval.

While the drug's peak sales potential is somewhat fuzzy due to the rare nature of this disorder (typical of orphan drugs in general), oral telotristat etiprate was granted "Orphan Drug Status" by the FDA for this patient population, meaning that it would likely garner a premium pricing structure upon approval.

But perhaps more importantly for investors, at least in the short-term, is the fact that the industry's appetite for gobbling up orphan drugmakers with promising clinical-stage products has gone largely unchecked this year. Lexicon's name is therefore almost certainly going to make its way into the buyout rumor mill in the wake of this positive clinical update. So, stay tuned!

The article Why Lexicon Pharmaceuticals' Stock Gained Over 50% Today originally appeared on Fool.com.

George Budwell has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright 1995 - 2015 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.