Intercept slips due SAFETY of Ocaliva"
Intercept Pharma slips 5% on FDA inquiry into safety of obeticholic acid
- Intercept Pharmaceuticals (ICPT -5.1%) is down on 60% higher volume in reaction to a report that the FDA is investigating a potential safety signal related to Ocaliva (obeticholic acid), specifically, the risk of liver injury. The inquiry began in May and could take a year to complete.
- The agency granted accelerated approval of the farnesoid X receptor agonist in May 2016 for primary biliary cholangitis which slowly destroys the bile ducts. Two Phase 3 studies in NASH patients are ongoing."
As per their latest Quarter:
"Net Loss
In the second quarter of 2020 we reported a net loss of $63.3 million, a decrease compared to a net loss of $71.4 million in the second quarter 2019.
Cash Position
As of June 30, 2020, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $540.6 million. As of December 31, 2019, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $657.4 million."
They seem to have major safety issue with their drug and significant negative cash flow!(cash burn between 60 to 70 M per quarter)
ICPT market cap 1,25 B VS THTX 172 M??