The PCSK9 story has been among biotech’s most volatile in recent years, with blockbuster expectations giving way to commercial disappointments and a fractious legal dispute. And Esperion Therapeutics, at work on a different anti-cholesterol technology, has been along for the entire ride, watching its share price top $100 at the height of PCSK9’s hype cycle and plummet roughly 90 percent as the market lost faith.
Now the Ann Arbor, Mich., company believes it’s on track to follow through on the early promise of its drug, an LDL cholesterol-lowering pill called bempedoic acid. After months of back and forth with the FDA over what it would take to get the drug approved, Esperion announced on Monday that the agency has signed off on its Phase 3 plan. The company is on track to file for approval by 2019, all while running a long-term outcomes trial of its own that will read out years later.