Leerink Remains Cautious on Intercept Pharma (ICPT) Amid Positive CHMP Opinion on Ocaliva
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Leerink affirms Intercept Pharma (Nasdaq: ICPT) with a Market Perform rating and $159 price target after the company received a positive CHMP opinion on Ocaliva.
The firm said,
This morning the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorization of ICPT's Marketing Authorization Application (MAA) for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), in line with expectations. As we discussed in detail earlier this year, we remain cautious about Ocaliva market uptake relative to Street estimates and had assumed EU approval by YE16 within this thesis.
ICPT only generated sales from a small number of patients in 2Q ($75k) during its ~1 month of commercial availability and we are looking forward to hearing about quantitative and qualitative guidance on how the first full quarter of US commercial availability has progressed. A key question for mgmt is how frequently patients are titrating to higher doses and at what time point, which may provide read-through to how actively these patients are being managed and how, if at all, physician's expectations for efficacy differ from the labeled dosing titration approach of waiting three months for adequate reduction of ALP and/or total bilirubin to be achieved.
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