Esperion Th (NASDAQ:ESPR)
Esperion Therapeutics, Inc. (ESPR), a biopharmaceutical company yesterday announced that they have failed to reach an agreement with the U.S Food and Drug Administration on a definitive approval path for the company’s cholesterol pill.
Esperion Therapeutics, Inc. CEO’s Comments
“We are pleased with our discussions and engagement with the FDA and EMA on the definition of statin intolerance and key design features of our planned CVOT. Scientific advice received from EMA provided clarity on the regulatory approval pathways for both an LDL-C lowering indication and a cardiovascular disease risk reduction indication in statin intolerance for bempedoic acid in Europe,” said Tim Mayleben, president and chief executive officer of Esperion Therapeutics. “Following engagement with FDA on the LDL-C lowering statin intolerance program for bempedoic acid in the U.S., the regulatory pathway for an LDL-C lowering indication is not well defined at this time due to the Agency’s view of a potentially evolving landscape. However, we remain confident in our ability to recruit and treat a patient population that will continue to be relevant to care in the U.S. at the time we seek approvals for bempedoic acid. We look forward to advancing our global Phase 3 and CVOT clinical programs later this year, which we anticipate will support our future global regulatory and marketing application submissions.” Globe Newswire
ESPR Technical Analysis
ESPR opened trading yesterday at $15.30 which was up from the previous days trading of $14.94. ESPR closed trading yesterday at $16.18 and tumbled down after market to $12.00, equivalent to a 26% decrease from the closing price. Taking a look at the daily chart we can see the last time ESPR traded below these levels was during the week of December 2nd 2013 when it traded at lows of $11.43. Taking a closer look at the daily chart we can see that ESPR has been in an downward trend dating back to July 20th when it traded at its 52 week high price of $100.98. ESPR has a float of 13.81 million shares and traded 1.27 times the normal daily trading volume on Tuesday. For trading purposes, I would like to see ESPR open trading on Wednesday below $13.40 and if it does I would be looking to take a short position at the bell. My stop loss would be $0.25 from my entry position fearing anything more than that and the stock would start to fill in the gap down.
Company Profile
Esperion Therapeutics, Inc., a biopharmaceutical company, focuses on the research, development, and commercialization of oral and low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with elevated LDL-C. Its lead product candidate is ETC-1002 or Bempedoic acid, an inhibitor of ATP Citrate Lyase, an enzyme on the cholesterol biosynthesis pathway that is in Phase III long-term safety and tolerability study to treat patients with hypercholesterolemia whose LDL-C is not adequately controlled with low- and moderate-dose statins. Bempedoic acid inhibits cholesterol synthesis in the liver, decreases intracellular cholesterol, and up-regulates LDL-receptors, resulting in increased LDL-C clearance and reduced plasma levels of LDL-C. Esperion Therapeutics, Inc. was founded in 2008 and is headquartered in Ann Arbor, Michigan.