Replies to post #243169 on 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.

[DewDiligence]

ICPT -21% on_FDA_briefing_doc_for Ocaliva/NASH adcomm:

https://finance.yahoo.com/news/us-fda-staff-flag-liver-131347282.html

I’ve posted many times that Ocaliva is simply a bad drug for NASH that should not be approved for this indication—e.g. #msg-169362197 and #msg-170082971. No amount of data reanalysis will change this.