Esperion encouraged to start CVOT promptly for ETC-1002

Esperion Therapeutics Inc. (NASDAQ:ESPR) shed $3.76 (11%) to $31.33 in after-hours trading after it said FDA had encouraged the company to "promptly" begin a cardiovascular outcomes trial (CVOT) for ETC-1002 to treat hypercholesterolemia. The company said concerns about the benefit/risk assessment of ETC-1002 "could necessitate" a completed CVOT before approval, and said the trial would be "well underway" before it submits an NDA for the ATP citrate lyase (ACLY) inhibitor.

In August, the company said FDA would not require a pre-approval CVOT (see BioCentury Extra, Aug. 17). ...