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ESPR

Esperion

$23.67

-5.98 (-20.17%)

07:32
03/20/17
03/20
07:32
03/20/17
07:32

Esperion reports FDA confirms path to approval for LDL-C lowering indication

Esperion Therapeutics announced the U.S. Food and Drug Administration recently confirmed that Esperion's LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid. Esperion plans to submit a new drug application, or NDA, by 1H 2019 for an LDL-C lowering indication based on the successful completion of the global pivotal Phase 3 program. The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high cardiovascular disease risk with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen Outcomes for bempedoic acid in patients with or at high risk for CVD who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered statin intolerant. For purposes of the CVOT, agreement has been reached with FDA that the following definition of statin intolerance is acceptable for the CVOT: "the inability to tolerate two or more statins, one at the lowest approved daily starting dose, due to an adverse effect," as defined in CLEAR Outcomes. The lowest approved daily starting statin doses include an average daily dose of less than5 mg rosuvastatin, less than10 mg of atorvastatin, less than10 mg simvastatin, less than20 mg lovastatin, less than40 mg pravastatin, less than40 mg fluvastatin and less than2 mg of pitavastatin. In CLEAR Outcomes, patients and investigators will provide written confirmation that the patient is statin intolerant and that the patient is aware of the benefits of statins in reducing the risk of cardiovascular events and death. The Company expects to submit an NDA for a cardiovascular disease risk reduction indication to the FDA and a Marketing Authorization Application to the European Medicines Agency by 2022, upon successful completion of CLEAR Outcomes.

  • 28

    Mar

ESPR Esperion
$23.67

-5.98 (-20.17%)

03/03/17
STFL
03/03/17
NO CHANGE
Target $45
STFL
Buy
Esperion price target raised to $45 from $30 at Stifel
Stifel analyst Thomas Shrader sees Esperion (ESPR) receiving regulatory clarity on its ongoing CVOT trial in the next few months following recent comments from President Trump urging streamlined FDA approvals. Esperion has designed its Phase 3 program to include patients similar to those enrolled in the PCSK9 trials, suggesting that ETC-1002 will receive the same eventual label, said Shrader, who raised his price target on the stock to $45 from $30. He keeps a Buy rating on Esperion.
03/09/17
FBCO
03/09/17
NO CHANGE
Target $29
FBCO
Underperform
Esperion price target raised to $29 from $12 at Credit Suisse
Credit Suisse analyst Vamil Divan raised his price target for Esperion to $29 from $12 given quarterly results, increasing probability of success for bempedoic acid and assuming it can get approved in 2019 prior to the completion of its cardiovascular outcomes trial. The analyst maintains an Underperform rating on the shares given the strong move the stock has had and ahead of the American College of Cardiology Meeting.
03/13/17
SBSH
03/13/17
NO CHANGE
Target $39
SBSH
Buy
Esperion selloff Friday a buying opportunity, says Citi
Citi analyst Joel Beatty views Friday's selloff in shares of Esperion Therapeutics as a buying opportunity. Beatty says Reuters' report that President Trump is expected to nominate Scott Gottlieb to lead the FDA is consistent with his Buy thesis on Esperion. The analyst notes that Gottlieb favors deregulation. Beatty keeps a Buy rating on Esperion with a $39 price target.
03/17/17
NEED
03/17/17
NO CHANGE
Target $25
NEED
Strong Buy
Needham calls Esperion selloff on Amgen data 'counter-intuitive'
Needham analyst Chad Messer believes the selloff in shares of Esperion Therapeutics (ESPR) based on Amgen's (AMGN) Repatha's data is "counter-intuitive." The fact that there was a statistically significant benefit confirms that LDL reductions prevent heart attacks and strokes, Messer tells investors in a research note. Bempedoic acid will likely be priced more in line with other oral cholesterol therapies, which makes the value debate for PCSK9 drugs a positive for Esperion, not a negative, the analyst contends. The analyst keeps a Buy rating on Esperion with a $25 price target.

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