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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