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OCALIVA for treatment of NASH
Non-alcoholic steatohepatitis (NASH) is becoming an increasingly popular disease affecting many worldwide. This disease leads to increased liver-related mortality secondary to liver cirrhosis (fibrosis) and even hepatocellular carcinoma (liver cancer). To date, there is no known FDA approved drug therapy for this disease and generally, 15-20% of patients with NASH will require a liver transplant.
The cure for NASH may potentially be the last blockbuster disease without a cure. Which is why there is an increasing number of biotech companies in a race to find a cure for this disease. Below you can see a list of companies with drugs in various different clinical trial stages asper FDAtracker.com.
Ocaliva (Obeticholic acid) is a 6-ethylchenodeoxycholic acid (obeticholic acid), a synthetic variant of the natural bile acid chenode oxycholic acid, is a potent activator of farnesoid X nuclear receptor. Stimulation of the farnesoid X nuclear receptor, promote insulin sensitivity and decrease hepatic gluconeogenesis and circulating triglycerides. Ocaliva has been used in pre-clinical studies, it improved hepatic steatosis, fibrosis, and portal hypertension.
Intercept Pharmaceuticals Inc. (ICPT) is expected to release news regarding their findings in the Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE trial) this week. Below, I breakdown the potential outcomes of this trial along with the likelihood that the company will succeed or fail with regards to getting FDA approval. Next, I highlight what the FDA will be looking for to provide approval and lastly, will provide my valuation of ICPT with associated risks and potential options play.
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