ICPT

OCALIVA® (obeticholic acid)

Primary Biliary Cholangitis (PBC)

Stage (next event)

Expected Date

Quarterly Sales (Approved)

February 26, 2021 (Est)

Catalyst Info & Data Links

TITLE: OCALIVA® (obeticholic acid) for Primary Biliary Cholangitis (PBC) - Quarterly Sales 


WHAT IS THE CATALYST EVENT?

  • Quarterly sales


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • February 26, 2021 (Est)


PRIOR DATA/EVENTS

  • Last quarter's sales e.g. $79.5M Q3/2020

  • See image below for quarter sales quarterly trend graph

  • 2020 Revenue guidance: Ocaliva Net Sales Guidance to narrow the range to $310 million to $320 million


PRESS RELEASES

Mechanism of Action

MECHANISM OF ACTION / RATIONALE

  • Obeticholic acid is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.


  • Source - FDA Label (section 12.1)

COMPETITORS

  • Elafibranor - Genfit

MARKET

  • ~19,000 PBC Patients In U.S.


  • Source - 06-2017 Corporate Presentation (slide 9)

Updated by HC

Prior Data (click to view full image)

Chart

Trial Design / Revenue (click to view full image)

Chart

Recent Posts

See what the community is saying - click to see full post

ICPT Ocaliva Phase 3 Readout

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