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 (NASDAQ: 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.
Latest Ratings for ICPT
| Date | Firm | Action | From | To |
|---|---|---|---|---|
| Mar 2022 | Canaccord Genuity | Maintains | Hold | |
| Mar 2022 | RBC Capital | Maintains | Sector Perform | |
| Mar 2022 | Needham | Maintains | Buy |
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