Esperion Updates Phase 2 Study and Keeps Volatility Traders Interested

So far in 2015 alone shares of Esperion have drastically outperformed the sector and a vast majority of other stocks in the market. Shares were up 87% year to date and they were up a whopping 367% in just the past 52-weeks.

This stock has been incredibly volatile in just the past month alone; investors and traders should be on the lookout. The past month has a trading range of $53.39 to $100.98 which is a massive swing and could be either very profitable or fruitless depending on how it is played.

Back to the study. The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need. This includes patients with heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD), who are already taking maximally tolerated statins yet require additional LDL-C reduction and where there is a positive benefit/risk ratio.

Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT). However Esperion plans to initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.

Tim M. Mayleben, President and CEO of Esperion, commented on this update:

After an informative and collegial meeting with the FDA, we are pleased that LDL-C remains an accepted clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patients with HeFH and/or patients with ASCVD. We have a clear regulatory path forward for development and approval of ETC-1002, an oral, once-daily treatment option for these patients that require additional LDL-C lowering.

Shares of Esperion closed Monday up 14.1% at $75.51 in its 52-week trading range of $15.00 to $120.96. In early trading indications Tuesday shares were up an additional 10.6% at $83.51. The stock has a consensus analyst price target of $123.90.