BioCentury
ARTICLE | Company News

Esperion hammered after regulatory setback

June 30, 2016 12:45 AM UTC

Esperion Therapeutics Inc. (NASDAQ:ESPR) sank $6.52 (40%) to $9.66 on Wednesday after it said FDA "did not provide clarity on a regulatory pathway" in dialogue with the company about an LDL-C lowering indication for bempedoic acid ( ETC-1002) in statin-intolerant patients. Esperion hopes to use LDL-C lowering as a surrogate endpoint in Phase III studies of the hypercholesterolemia candidate. The company said its submission of an NDA for bempedoic acid could be delayed until as late as 2022. Esperion released the update after market hours Tuesday (see BioCentury Extra, June 28). ...