11. Ocaliva

microscope image of nash

Active ingredient: obeticholic acid
Disease: primary biliary cholangitis
Peak annual sales estimate: $1.6 billion to $8.6 billion
Approved: May 27
Company: Intercept Pharmaceuticals

The scoop: While Intercept will be pleased that it gained a speedy FDA approval for Ocaliva in the liver condition primary biliary cholangitisin combo with ursodeoxycholic acidthis summer, it will be eyeing the potentially much bigger license for non-alcoholic fatty liver disease, or NASH, as its main prize. This disease space, which affects millions of Americans and is related to the rise of obesity, could be worth as much as $40 billionwith Intercept racing a host of other biotechs and pharmas to be the first to market. At the top end, Morgan Stanley’s Andrew Berens predicts an eye-watering $8.6 billion in peak sales from Ocaliva, should it also gain a NASH license. It has seen setbacks in testing, but it is planning to peek at some interim NASH data from its latest test next year to see whether it can go for an early FDA approval. —Ben Adams

11. Ocaliva

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