Cowen Comments On Intercept Pharmaceuticals As It Wins FDA ‘Breakthrough’ Status For OCA
Cowen’s healthcare analyst Ritu Baral is weighing in with her thoughts on Intercept Pharmaceuticals (NASDAQ:ICPT), following the news that the company’s investigational product obeticholic acid (OCA) has received “breakthrough therapy designation” from the FDA for the treatment of patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
The analyst rates the stock a Buy with a price target of $420, which represents a potential upside of 102% from where the stock is currently trading.
Baral noted, “We see OCA’s new breakthrough status as supporting our base case assumption of a subpart H filing for potential conditional approval for NASH based on an 18- mo. surrogate primary endpoint. But, we see little to no impact on direct chances of approvability or potential need for pre-approval CV risk studies (the latter of which we saw as low to start).” The analyst added, “We think breakthrough says little on FDA’s final view on acceptability of the potential safety impact of LDL signals seen with OCA. However, we continue to think these signals are more benign than many investors fear, and this will likely be elucidated in ICPTs upcoming NASH lipids study.”
Intercept Pharmaceuticals, Inc., a development stage biopharmaceutical company, focuses on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases utilizing its proprietary bile acid chemistry.