Intercept Pharmaceuticals (ICPT)

[DewDiligence]

ICPT receives CRL for Ocaliva NDA in NASH:

https://www.globenewswire.com/news-release/2020/06/29/2054576/0/en/Intercept-Receives-Complete-Response-Letter-from-FDA-for-Obeticholic-Acid-for-the-Treatment-of-Fibrosis-Due-to-NASH.html

The CRL indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.

As regular readers of this board know, I’ve long been bearish on Ocaliva for NASH (e.g. #msg-152659994), so today’s CRL is hardly surprising, IMO.