PBC Committee Opens The Door to $2.2B Opportunity For Intercept Pharma (ICPT) - Wedbush
Wedbush analyst, Liana Moussatos, reviewed the FDA's briefing documents for Intercept Pharmaceuticals (NASDAQ: ICPT) obeticholic acid (OCA) in primary biliary cholangitis (PBC) Advisory Committee meeting and does not see any major red flags for approval.
As the analyst anticipated, the FDA appears to be focused on the validity of the primary endpoints (ALP and bilirubin) and whether the improvement seen in the OCA trials confers a clinically meaningful benefit. The FDA criticized the enrollment of early-stage PBC patients in the Phase 3 POISE trial as not being representative of all PBC disease stages (92% of patients in the trial had normal bilirubin at baseline) which could impact the label for OCA in moderate to advanced PBC patients with both abnormal ALP and bilirubin; the Global PBC study showed that improvements in both ALP and bilirubin was correlated with transplant-free survival. The FDA also commented that there were not enough monotherapy patients in the Phase 3 POISE trial or in the confirmatory COBALT study. Both of these issues appear to be more of a labelling question and should not affect the approval chances of OCA.
Intercept is developing OCA as a treatment candidate for PBC as well as other liver diseases (e.g. NASH and PSC). The Phase 3 POISE program had highly positive clinical results in our view. The data package Intercept submitted to the FDA and EMA included efficacy and safety results from multiple randomized, placebo controlled clinical trials which statistically hit (p<0.0001) the primary endpoint of reducing ALP and improving bilirubin levels.
The firm maintained an Outperform rating and $423 fair value target on ICPT.
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Shares of Intercept Pharmaceuticals closed at $151.31 yesterday.