MLV Offers Commentary on Intercept Pharmaceuticals Inc Following Updates on NDA and MAA Submissions
In a research report issued today, MLV analyst Vernon Bernardino reiterated a Hold rating on Intercept Pharmaceuticals Inc (NASDAQ:ICPT) with a price target of $273, after the company announced the submission of its New Drug Application (NDA) with the FDA for obeticholic acid (OCA) in primary biliary cirrhosis (PBC) and European Medicines Agency (EMA) acceptance of its Marketing Authorization Application (MAA) for OCA in PBC.
Bernardino observed, “We believe OCA has potential to be an important treatment option for patients with PBC, however, we make no changes to our models at this time, as the announcement is in line with our expectations for seeking approval for OCA in combination with ursodeoxycholic acid (UDCA) as a treatment for PBC in patients with an inadequate response to UDCA, or as monotherapy in those unable to tolerate UDCA, which is currently the only approved drug for the treatment of PBC. As OCA is a new molecular entity, we do not anticipate accelerated approval but do anticipate an Advisory Committee is convened to review the NDA.”
Bottom line: “We believe upside potential and downside risk in ICPT stock fairly balanced at current prices and maintain our Hold rating and $273 PT.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Vernon Bernardino has a total average return of -5.7% and a 40.3% success rate. Bernardino is ranked #3465 out of 3683 analysts.