Did Improper Practices Affect Growth Trends For Intercept Pharma's Drugs?

Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) plummeted to a new 52-week low of $90.53 Tuesday morning before recovering a few dollars per share in reaction to a warning letter from the company to physicians. The letter cautioned against overdosing certain patients suffering from primary biliary cholangitis with the company's treatment therapy called Ocaliva.

"In addition, serious liver adverse events have been reported in patients initiating therapy without cirrhosis or with mild liver impairment," Intercept said in its letter. "Liver-related adverse events have occurred both early in treatment and after months of treatment."

It is not yet clear if patients were not dose-escalated in an appropriate manner or exceeded the recommended dose levels, Cantor Fitzgerald's Elemer Piros, Ph.D., commented in a brief research report. As such, it is nearly impossible to quantify the impact on future sales at this time but it does nevertheless "raise caution."

"In our view, these events raise caution on the PBC franchise's future growth potential in more severe patients, signal a potential hurdle for further penetration and/or adoption of the treatment," the analyst wrote.

Piros' Underweight rating on Intercept's stock remains unchanged after the letter along with a fair value valuation of $69 per share.

Related Links:

Intercept Pharma Analysts See Growth Ahead, But Keep Underweight Rating For Now

Analysts Split On How To Read Intercept Switching Clinical Trial Endpoints