Esperion rises after FDA clarifies regulatory path

Esperion Therapeutics Inc. (NASDAQ:ESPR) jumped $17.40 (74%) to $41.07 on Monday after it said FDA confirmed that its Phase III program for bempedoic acid (ETC-1002) is adequate to support approval in an LDL-C lowering indication. The company plans to submit regulatory applications to FDA and EMA by 1H19 for the ATP citrate lyase (ACLY) inhibitor.

The news allayed investor fears that FDA would not accept LDL-C lowering as an approvable surrogate endpoint for CV benefit, and that it would require CV outcomes data prior to the candidate’s approval. Esperion has said a requirement for CVOT data could push a U.S. launch back to 2023 (see BioCentury, July 11, 2016)...