FDA Restricts Use Of Intercept's Ocaliva In Liver Disease with Advanced Cirrhosis Citing Risk Of Serious Liver Injury

The FDA has issued a statement restricting the use of Intercept Pharmaceuticals Inc’s ICPT Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosis.
PBC is a rare, chronic disease affecting the ducts in the liver that carry bile, which helps with digestion.
Some PBC patients with cirrhosis who took Ocaliva, especially those with evidence of advanced cirrhosis, developed liver failure, sometimes requiring liver transplants.
However, for patients who do not have advanced cirrhosis, “the benefits of Ocaliva outweigh the risks for PBC,” the FDA says in the statement citing clinical trials.
Also, B. Riley Securities analyst Mayank Mamtani downgraded the firm from Buy to Neutral and lowered the price target from $65 to $18.
The analyst no longer sees a favorable risk-reward given the view of “a narrowing path of market entry” in NASH. While “encouraged” by Intercept’s constructive dialogue with FDA, Mamtani sees a “high likelihood” of FDA denying approval based on surrogate approval unless a clear correlate is established prospectively with a clinical liver outcomes endpoint.
Though, the investors are apparently reacting to commentary from Jefferies saying that the FDA update to Intercept label for Obeticholic Acid was in line with expectations.
It sees the update to negatively impact 10-20% of the current PBC market.
Price Action: ICPT shares are up 8.7% at $16.81 during the market session on the last check Wednesday.