Biotech Values

[DewDiligence]

ICPT -15% on phase-3 Ocaliva failure in compensated cirrhosis due to NASH:

https://finance.yahoo.com/news/intercept-pharmaceuticals-announces-reverse-phase-115500269.html

Intercept Pharmaceuticals…today announced that REVERSE, a Phase 3 study evaluating the safety and efficacy of OCA in patients with compensated cirrhosis due to nonalcoholic steatohepatitis (NASH), did not meet its primary endpoint of a >=1-stage histological improvement in fibrosis with no worsening of NASH following up to 18 months of therapy.

…The Company’s planned NDA for its lead indication of liver fibrosis due to NASH will be supported by positive Phase 3 data from the REGENERATE study and is unaffected by the efficacy results of REVERSE. The Company is on track to resubmit its NDA in liver fibrosis due to NASH by the end of the year.

ICPT’s continued pursuit of Ocaliva approval in NASH is an instance of Zebra’s Law, IMO.