Esperion Therapeutics, Inc. (NASDAQ: ESPR) had a huge move in Monday’s trading session as the result of an analyst upgrade but it looks like this company has kept the rally alive into Tuesday with an update from its phase 2 study. The company provided an update today from the ETC-1002 (bempedoic acid) end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) last week.

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.

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