Esperion Update Not Enough for Investors
Esperion plans to conduct multiple Phase 3 clinical trials that will separately evaluate patients with statin intolerance.
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Esperion Therapeutics Inc. (NASDAQ: ESPR) has been sliding over the past month, just like many other stocks in the health care sector. It doesn’t help that the company released some updated plans for its intended Phase 3 trial, but these still must be finalized and approved.
The company provided an update on the design and timing of its planned pivotal Phase 3 clinical development program following receipt of the official end-of-Phase 2 meeting minutes from the U.S. Food and Drug Administration (FDA).
Basically, Esperion plans to conduct multiple Phase 3 clinical trials that will separately evaluate patients with statin intolerance, as well as patients who are inadequately treated despite maximally tolerated statin therapy.
For statin-intolerant patients who have a high unmet medical need, the company is in the works with key opinion leaders and will continue to seek advice from global regulatory authorities on the design of the Phase 3 program. These specifics of the Phase 3 development program are anticipated to be finalized by the first half of 2016.
Tim M. Mayleben, president and CEO of Esperion, said:
Our entire team is focused on delivering a Phase 3 program that will meet the approval requirements of major regulatory agencies around the world. We continue to advance toward the potential worldwide approval of ETC-1002 as a new oral, once-daily treatment option. We remain confident that patients, physicians, and payers will welcome a new, oral LDL-C lowering therapy, especially for those patients who are considered to be intolerant of statin therapy.
So far in 2015 Esperion has underperformed the market, as the stock is down 13% year to date. Over the past 52 weeks, shares are up 52%, as of Monday’s closing price.
Shares of Esperion closed Monday down 10.9%, at $35.09 in a 52-week trading range of $18.00 to $120.96. In early trading indications Tuesday, shares were down an additional 14.7% at $29.95. The stock has a consensus analyst price target of $120.20.
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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
His work has been quoted, or referenced by a number of outlets including Business Insider, USA Today, Yahoo Finance, MSN, The Motley Fool, and many other publications. A graduate of Southwestern University, he studied business with a focus on investments and has previous experience in banking and startups.
When not reading or writing the news, he is following his passion for Lacrosse, playing chess, or building solar projects with his dad.
