Esperion Therapeutics Inc (NASDAQ:ESPR)
After closing deep in red on Friday, Esperion Therapeutics Inc (NASDAQ:ESPR) stock provided shareholders a case of whiplash with a 74% gain to close Monday’s session. Yesterday, the clinical-stage lipid management firm informed shareholders that it anticipates the U.S. FDA to eventually permit a new drug application.
Esperion Therapeutics Inc (NASDAQ:ESPR) reported that the U.S. FDA confirmed that company’s LDL-C lowering program is satisfactory to support an LDL-C reducing indication for bempedoic acid. The company intends to file a new drug application by 1H2019 for an LDL-C reducing indication depending on the successful closure of the international Phase III plan.
The projected product label would count specific language for application of bempedoic acid as an assistant to maximally tolerated statin treatment in people with hypercholesterolemia, particularly those at high cardiovascular disease risk with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia who need additional LDL-C lowering.
Tim M. Mayleben, the CEO and President of Esperion Therapeutics Inc (NASDAQ:ESPR), reported that they are delighted to have received clarity from the U.S. FDA pertaining company’s LDL-C lowering development plan. The skilled lipid management team has functioned closely with monitoring authorities and the main advisors to achieve this promising outcome.
They continue to consider that bempedoic acid has the prospect to offer physicians with a convenient and complementary oral treatment alternative that’s cost-effective for their people with hypercholesterolemia who need additional LDL-C lowering.
They remain focused on closing the international pivotal Phase III plan for bempedoic acid and recording top-line report from their long-term tolerability and safety study by Q2 2018 and top-line report from ongoing Phase III LDL-C lowering efficacy trials by mid-2018.
Interactions with the U.S. FDA addressed the current cardiovascular outcomes study (“Cholesterol Lowering against BEmpedoic Acid”) outcomes for bempedoic acid in people with or at increased risk for CVD who are able to accept less than the lowest permitted daily initial dose of a statin and are seen as statin intolerant.
Shares of Esperion Therapeutics Inc (NASDAQ:ESPR) smashed 52-week high yesterday, touching a peak of $42.59. After opening at $32.10, the stock continued to move up on the chart, and eventually closed with gains of more than 74% at $41.22. The firm now has a market cap of over $742 million. Many consider a stock hitting its 52-week on strong volume as a sign of momentum, which indicates a signal to buy. For ESPR, the new high came on massive volume of 30.49 million compared to average share volume of 1.64 million.
|Last Price a/o 3:21 PM EST||$41.22|
|Market Cap (mlns)||$929.92M|
|Shares Outstanding (mlns)||22.56M|
|Share Float (mlns)||19.60M|
|Short Interest Ratio||4.54|
I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.
About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.