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 Intercept Pharmaceuticals (NASDAQ:ICPT), a clinical-stage biopharmaceutical company focused on developing therapies to treat chronic liver disease, exploded higher by as much as 320% (that's not a misprint) today following a clinical update on its phase 2b Flint trial involving obeticholic acid (OCA) as a treatment for nonalcoholic steathohepatitis (NASH), a disease characterized by fat accumulation in the liver which can lead to cirrhosis, the need for a transplant, or death.
So what: According to Intercept's press release, the data safety monitoring board has recommended the Flint trial be stopped early based on OCA meeting its primary endpoint and highly statistically significant improvement in liver histology. The DSMB reviewed liver biopsy data from roughly half of all trial patients and noted that the primary endpoint – a decrease in the NAFLD Activity Score of at least two points with no worsening of fibrosis – was met.
Now what: In my 15 years of investing, I can recall but a handful of instances where I've seen a non-micro-cap or small-cap company explode higher by 320% in a single session – and certainly none of them moved higher by $230 per share! There are obviously huge implications here for OCA given that an estimates 12% of the U.S. population has NASH and some 6 million people in the U.S. are projected to have advanced liver fibrosis or cirrhosis, which is where OCA could be of incredible benefit. Then again, I am a realist, and a $200-plus move higher better come with absolutely utopian clinical data and execution from here on out or it will be clobbered. As much as today's move is exciting and reminds investors of the potential of the biotech sector, I'm sticking to the sidelines.