By Chris Wack


Esperion shares were up 16% to $2.67 after the company said Friday the U.S. Food and Drug Administration approved broad new label expansions for Nexletol bempedoic acid tablets and Nexlizet bempedoic acid and ezetimibe tablets.

The stock closed Friday's session up 9% after the news came out, and is now up 66% in the past 12 months.

Esperion said the approval was based on positive data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients.

The enhanced labels support the use of Nexletol and Nexlizet either alone or in combination with statins. They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.

The company said its pending label expansions in Europe remain on track, with a positive opinion received from the Committee for Medicinal Products for Human Use on Thursday. Esperion anticipates a final determination by the European Medicines Agency in the second quarter.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

03-25-24 1118ET