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ESPR

Esperion

$54.43

-4.03 (-6.89%)

13:08
11/11/18
11/11
13:08
11/11/18
13:08

Esperion announces presentation of final Study 3 results of Bempedoic Acid

Esperion announced that the final Phase 3 results from Study 3 were presented at the American Heart Association Scientific Sessions in Chicago. This study evaluated the LDL-C lowering efficacy and the safety and tolerability of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease, or at high risk for ASCVD with hypercholesterolemia, inadequately treated with maximally tolerated background LDL-C lowering therapy who are only able to tolerate less than the approved daily starting dose of a statin and considered statin intolerant. Topline results were previously announced in May 2018. The 24-week, global pivotal Phase 3 randomized, double-blind, placebo-controlled, multicenter study evaluated the LDL-C lowering efficacy and safety of bempedoic acid 180 mg/day versus placebo added to background lipid-modifying therapy in patients with hypercholesterolemia who are considered statin intolerant. The study was conducted at 67 sites in the U.S. and Canada. A total of 345 patients were randomized 2:1 to receive bempedoic acid or placebo. The primary efficacy objective was to assess the 12-week LDL-C lowering efficacy of bempedoic acid versus placebo. Secondary objectives included evaluating the 24-week LDL-C lowering efficacy of bempedoic acid versus placebo, the safety and tolerability of bempedoic acid versus placebo, and its effects on other risk markers after 12 weeks of treatment, including hsCRP. Esperion plans to submit New Drug Applications to the U.S. Food and Drug Administration for bempedoic acid and the bempedoic acid/ezetimibe combination pill for LDL-C lowering indications during the first quarter of 2019. Additionally, Esperion plans to submit Marketing Authorization Applications to the European Medicines Agency during the second quarter of 2019.

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ESPR Esperion
$54.43

-4.03 (-6.89%)

10/16/18
BTIG
10/16/18
INITIATION
Target $82
BTIG
Buy
Esperion initiated with a Buy at BTIG
BTIG analyst Thomas Shrader initiated Esperion (ESPR) with a Buy rating and a price target of $82, saying that with its development of bempedoic acid, or BA, to reduce cholesterol, the next key question is about the drug's safety. The analyst notes that while the data from Study 1 in May were disappointing, Study 2 readout in the next few weeks should have more answers. Shrader adds that the introduction of "non-stain" into the cholesterol market has already worked for Merck's (MRK) Zetia, and if BA is perceived well on its safety profile, it is "highly supportive" of its investment story.
10/29/18
NORL
10/29/18
UPGRADE
NORL
Outperform
Esperion upgraded to Outperform from Market Perform at Northland
10/29/18
10/29/18
UPGRADE
Target $65

Outperform
Esperion upgraded to Outperform at Northland
As previously reported, Northland upgraded Esperion to Outperform from Market Perform with a $65 price target. Analyst Carl Byrnes said the positive TRL of Study 2 of '047 clearly supports BA's efficacy in lowering LDL-C, and should ease safety concerns arising from the May TLR study 1.
10/29/18
JMPS
10/29/18
NO CHANGE
Target $153
JMPS
Outperform
JMP reiterates $153 price target on Esperion following conference call
overall for the bempedoic acid Phase 3 program, JMP Securities analyst Jason Butler tells investors in a research note. He reiterates an Outperform rating on the shares with a $153 price target. The stock in afternoon trading is down 76c to $41.12. Management reiterated key takeaways from the Study 2 results, including the "clean safety profile and robust LDL-c lowering efficacy," especially in statin intolerant patients, with favorable MACE trends, says Butler. He continues to believe the LDL-C and hsCRP reductions, and optimized trial design, support a high probability that bempedoic acid will show a "robust and clinically important" cardiovascular risk reduction in the Clear outcomes trial. Bempedoic acid has a "clear commercial opportunity" as an oral therapy to address the millions of patients who remain inadequately controlled with elevated LDL-C despite currently available treatment options, Butler contends.

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