Esperion Therapeutics (ESPR) has tumbled over 40% today after the biotech company said it might not be able to win FDA approval for its anti-cholesterol drug based on its cholesterol-cutting ability alone as the FDA wouldn’t provide the company with clarity on whether proof that the drug lowers bad cholesterol.
This has raised concerns among investors that it could take as many as six more years before the FDA approves the company’s anti-cholesterol drug, known as low-density lipoprotein, or LDL, for U.S. markets.
Esperion stated that it will start two sets of studies by the end of this year. The first, to be completed by 2019, will show whether the drug significantly lowers bad cholesterol, which until now has been the route to getting approval. The second will assess whether the pill reduces heart complications in high-risk patients who aren’t able to take statin medications. Esperion plans to submit the results to regulators by 2022.
Esperion Therapeutics, Inc. is a pharmaceutical company focused on developing and commercializing oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with elevated LDL-C. The company’s segment is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C. Esperion‘s lead product candidate is ETC-1002, or bempedoic acid. Esperion Tx is engaged in conducting a global Phase III long-term safety and tolerability study of bempedoic acid in patients with hyperlipidemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. Bempedoic acid is an inhibitor of ATP Citrate Lyase (ACL), a well-characterized enzyme on the cholesterol biosynthesis pathway. Bempedoic acid inhibits cholesterol synthesis in the liver, decreases intracellular cholesterol and up-regulates LDL-receptors.
ESPR has dropped back to under $10 per share with the recent LDL news. The stock is now trading at all-time lows since going public in 2013. Remarkably, the stock peaked at well over $100 just last year.
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