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Esperion Therapeutics wins FDA approval on a pair of new drug applications; shares jump

Bempedoic acid and the bempedoic acid ezetimibe combination tablet are designed to decreased lipid levels in patients with elevated low-density lipoprotein cholesterol
keyboard that says 'FDA approved' on the shift key, as well as a literal key
The next step is filing and regulatory review, which the FDA hopes to complete in February 2020

Esperion Therapeutics Inc (NASDAQ:ESPR) said it has earned the Food and Drug Administration's approval on two new drug applications, sending the shares higher Monday.

Bempedoic acid and the bempedoic acid ezetimibe combination tablet are designed to decreased lipid levels in patients with elevated low-density lipoprotein cholesterol. The next step is filing and regulatory review.

The stock jumped more than 12% to $48.47.

READ: Esperion Therapeutics shares pop on successful Phase 3 trial for bempedoic acid

“It is exceptional that our New Drug Applications for both bempedoic acid and bempedoic acid ezetimibe combination tablet have been accepted for filing,” President and CEO Tim Mayleben said. “The acceptances validate the extraordinary effort and high-quality submissions of our lipid management team and brings our once-daily, oral bempedoic acid-based therapies one step closer to the physicians and patients who will benefit from them.”

The FDA’s goal dates for completing the regulatory review are in February 2020. There is no plan to hold an advisory committee meeting currently in place.

Esperion, also known as the the lipid management company, is focused on developing once-daily oral therapies for patients with high LDL-Cholesterol.

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

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