Esperion Therapeutics Inc (NASDAQ:ESPR), a pharmaceutical company focused on developing and commercializing a first-in-class, oral therapy for low-density lipoprotein cholesterol (LDL-C) lowering for the treatment of patients with hypercholesterolemia, 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).
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. This dual strategy will leverage the profile of ETC-1002 to differentiate the drug in the statin intolerant patient population, while also preserving the opportunity to develop the drug as an add-on to maximally tolerated statin therapy.
For statin intolerant patients who have a high unmet medical need, Esperion is working with key opinion leaders and will continue to seek advice from global regulatory authorities on the design of the Phase 3 program. Specifics of the Phase 3 development program are anticipated to be finalized by the first half of 2016.
For patients on maximally tolerated statin therapy who require additional LDL-C lowering, Esperion will plan to conduct efficacy and long-term safety trials. FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly, which would be well underway at the time of the New Drug Application submission and review, since any concern regarding the benefit/risk assessment of ETC-1002 could necessitate a completed cardiovascular outcomes trial before approval. Esperion intends to initiate a global long-term safety study for ETC-1002 by the end of 2015.
“Our entire team is focused on delivering a Phase 3 program that will meet the approval requirements of major regulatory agencies around the world,” said Tim M. Mayleben, president and chief executive officer of Esperion. “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.” (Original Source)
Shares of Esperion Therapeutics are up 0.06% to $35.11 in after-hours trading. ESPR has a 1-year high of $120.96 and a 1-year low of $18. The stock’s 50-day moving average is $52.04 and its 200-day moving average is $82.78.
On the ratings front, Esperion has been the subject of a number of recent research reports. In a report issued on August 31, Chardan analyst Gbola Amusa MD CFA reiterated a Sell rating on ESPR, with a price target of $36, which represents a slight upside potential from current levels. Separately, on August 25, Credit Suisse’s Vamil Divan maintained a Hold rating on the stock and has a price target of $86.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Gbola Amusa MD CFA and Vamil Divan have a total average return of 3.3% and 27.4% respectively. CFA has a success rate of 48.5% and is ranked #1252 out of 3759 analysts, while Divan has a success rate of 66.7% and is ranked #110.
Overall, one research analyst has rated the stock with a Sell rating, one research analyst has assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $86.00 which is 145.1% above where the stock opened today.
Esperion Therapeutics Inc is engaged in the research, development and commercialization of therapies for the treatment of patients with elevated levels of elevated levels of LDL-C.