Small-Cap Biotech Esperion Surges On FDA Acceptance Of Cholesterol Drug Applications

Shares of small-cap biotech Esperion Therapeutics Inc ESPR were rallying Monday after the company received good news from the DFA.

What Happened

Esperion announced the FDA has accepted its New Drug Application filings for both bempedoic acid and a bempedoic acid-ezetimibe combo tablet.

Both treatment candidates are being developed as complementary, once-daily oral therapies for patients with elevated low-density lipoprotein cholesterol who need additional LDL-C lowering despite the use of currently accessible therapies.

Why It's Important

In the U.S. 96 million people — more than 37 percent of the adult population — have elevated LDL-C. About 18 million people in the U.S. live with atherosclerotic cardiovascular disease and have elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy.

These two therapies are likely to help Esperion accomplish its mission of delivering once-daily oral therapies that complement existing oral drugs to provide the additional LDL-C lowering that patients need, according to the company. 

What's Next

The PDUFA date for bempedoic acid is Feb. 21, 2020; for the bempedoic acid/ezetimibe combo tablet, it's Feb. 26, 2020.

The FDA communicated that it has no plans to hold an advisory committee meeting to discuss these applications, according to Esperion. 

The marketing authorization applications for these product candidates are also under review by the European Medicines Agency.

Related Links:

Vistagen Shares Fall Under $1 After Depression Drug Flunks Midstage Trial

The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs