May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx
FDA accepts Esperion NDAs for LDL-C-lowering indications
Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe combination tablet to treat elevated LDL-C in patients who need additional LDL-C lowering despite the use of currently accessible therapies. The PDUFA dates are Feb. 21, 2020 and Feb. 26, 2020, respectively, and Esperion said FDA has no plans to hold an advisory committee meeting to discuss the applications.
EC approves BioMarin's phenylketonuria therapy
The European Commission approved Palynziq pegvaliase from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to reduce blood phenylalanine concentrations in patients ages 16 and older with phenylketonuria. FDA approved the pegylated recombinant phenylalanine ammonia lyase enzyme in May 2018...