Deutsche Bank maintained a Buy rating on Intercept Pharmaceuticals (NASDAQ: ICPT) and a raised its price target to $500.00 (from $395.00). Analyst Alethia Young has more confidence in OCA as a leading therapy in NASH.
"Intercept provided more data on the Ph2b FLINT study, and we view the data as rel straightforward & better than our expectations. Fibrosis benefit at a short duration & w/o powering is the biggest surprise. Safety looks good with no CV risk, and we think NASH clearance can be achieved with more pts and/or longer duration. We see real catalysts around faster approval, regulatory clarity, and pricing. We are lowering the discount rate to 10% (from11%) and increasing the prob of success in NASH to 90% (from 75%). Reiterate Buy," said Young.
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Summer Street affirms its Buy rating and $650 target price on Intercept Pharmaceuticals (Nasdaq: ICPT) following Q2 results and FLINT study update issued Monday night.
Analyst Jim Molloy made the following interpretations following Intercept's report:
-- Efficacy data looks great, fibrosis data a huge positive. OCA hit on the primary endpoint of a reduction in NAS scores, and while exact data remains embargoed until the AASLD meeting in November, ICPT (or the NIH, more properly) did disclose that all three components of the NAS score (fibrosis, ballooning, and steatosis) hit a statistically significant reduction from baseline. It was unexpected to see change in fibrosis, given the (relatively) short time frame of the trial (71 weeks), but we see the reduction in fibrosis as a significant positive for the utility of OCA in treating NASH, even given the lack of statistical significance in resolving NASH.
-- Safety looked surprisingly benign. A key concern had been the dyslipidemia issues that the NIH had highlighted in January following the early stoppage of the trial. Surprisingly, the full lipid data set seemed to show a much more benign dyslipidemia effect, and one that appears to resolve upon discontinuation of therapy. Additionally, the 10 cardiovascular events disclosed by ICPT earlier in the year appear to have no difference in the active from placebo, most of the events appear to be drug related, and the two deaths in the study were not drug related.
-- Sovaldi could be a reasonable compare for launch. NASH has the potential to be a hepatitis-C-sized market, with an estimated 8MM people in the US with late-stage NASH currently. We believe it’s not unreasonable to think that, should these results hold up in phase III trials, OCA could reach Sovaldi-like status, with multi-billions per quarter in sales. |
