Intercept Pharma (ICPT) Halted Ahead of FDA AdCom for OCA

Intercept Pharma (NASDAQ: ICPT) is halted today ahead of an FDA adcom for its obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

FDA briefing documents were recently posted and analysts have been overall positive on approval.

Baird analyst Brian Skorney said the briefing docs were "boring" which he said "is a good thing."

Wedbush analyst, Liana Moussatos, does not see any major red flags for approval. She notes, as 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.

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