Biotech Values

[DewDiligence]

ICPT +26%/PM on phase-3 REGENERATE data, which hit one of two primary endpoints for NASH patients:

https://finance.yahoo.com/news/intercept-announces-positive-topline-results-120000280.html

In the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (>=1 stage) with no worsening of NASH at the planned 18-month interim analysis (p=0.0002 vs. placebo).

In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, but this did not reach statistical significance. As agreed with the U.S. Food and Drug Administration (FDA), in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints.

Full dataset to be presented at EASL.

Ocaliva (OCA) is an FXR agonist. I’ve posted on numerous occasions that I don’t think Ocaliva has what it takes to garner big sales, due to its side-effect profile, and the top-line REGENERATE data are consistent with such a viewpoint.