Esperion Therapeutics (NASDAQ:ESPR) is up 33% premarket on robust volume in response to its announcement that the FDA has confirmed that the design of its Phase 3 program developing bempedoic acid for lowering low density lipoprotein cholesterol (LDL-C) is sufficient to support approval. Late-stage development began in January 2016 (Study 1). Three Phase 3 studies (Study 2, Study 3, Study 4) specific to LDL-C lowering are currently recruiting patients.
The company says that if all goes according to plan, it will be in position to submit a New Drug Application (NDA) by H1 2019.
A cardiovascular outcomes trial (CVOT) was initiated in Q4 2016 and will involve ~12,600 patients. An NDA for cardiovascular disease risk reduction could be filed by 2022.