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ESPR

Esperion

$40.96

1.23 (3.10%)

07:53
11/04/19
11/04
07:53
11/04/19
07:53

Esperion announces pooled analyses from Phase 3 program of bempedoic acid

Esperion announced that pooled analyses from four Phase 3 clinical trials of bempedoic acid will be presented at the American Heart Association Scientific Sessions in Philadelphia on Sunday, November 17, 2019. Bempedoic acid is being developed as a cost-effective, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol added onto maximally tolerated statin therapy. Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination tablet's new drug applications are currently under regulatory review by the U.S. Food and Drug Administration, and the marketing authorisation applications are currently under centralized review by the European Medicines Agency. Esperion completed its global, pivotal, Phase 3 clinical development program and announced positive cumulative results in October 2018. The program evaluated the safety, tolerability and LDL-C-lowering efficacy of bempedoic acid and the bempedoic acid / ezetimibe combination tablets in patients with hypercholesterolemia who either have atherosclerotic cardiovascular disease or are at high risk of ASCVD, and who continue to have elevated levels of LDL-C despite the use of maximally-tolerated statins and ezetimibe, leaving them at high risk for cardiovascular events. The program included over 4,000 patients across five studies, four for bempedoic acid. With a targeted mechanism of action, bempedoic acid is a first-in-class, ATP Citrate Lyase inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Bempedoic acid has been observed to reduce hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 3 studies conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering when used with low dose or no background statin. Through the complementary mechanisms of action of inhibition of cholesterol synthesis and inhibition of cholesterol absorption, the bempedoic acid / ezetimibe fixed dose combination tablet is a non-statin, orally available, once-daily, LDL-C lowering therapeutic candidate, currently under review by the FDA and EMA. Inhibition of ATP Citrate Lyase by bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Inhibition of Niemann-Pick C1-Like 1 by ezetimibe results in reduced absorption of cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver. Phase 3 data demonstrated that this combination resulted in a 29 percent placebo corrected LDL-C lowering when used with maximally tolerated statins, a 44 percent LDL-C lowering when used with no background statin, and a 34 percent reduction in high sensitivity C-reactive protein. The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. Esperion initiated a global cardiovascular outcomes trial to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease who are only able to tolerate less than the lowest approved daily starting dose of a statin and considered "statin averse." The CVOT - known as CLEAR Cardiovascular Outcomes Trial - is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries

  • 21

    Feb

  • 26

    Feb

ESPR Esperion
$40.96

1.23 (3.10%)

09/16/19
GSCO
09/16/19
UPGRADE
Target $45
GSCO
Neutral
Esperion upgraded to Neutral from Sell at Goldman Sachs
Goldman Sachs analyst Paul Choi upgraded Esperion to Neutral from Sell but lowered his price target on the shares to $45 from $55, stating that he now sees less risk of the launch performance of bempedoic acid disappointing over the intermediate term since 2019-2022 consensus revenue estimates have come down "meaningfully." His product revenue estimates are mostly unchanged, but Choi has increased his launch related cost assumptions and slightly delayed R&D costs related to development of bempedoic acid in diabetics, the analyst noted in explaining his change in price target.
09/16/19
09/16/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Raytheon (RTN) upgraded to Overweight from Neutral at JPMorgan with analyst Seth Seifman saying the stock's outperformance thus far in September is a sign of increasing investor confidence in the outlook for Raytheon and for the United Technologies (UTX) combination, along with some mean reversion. 2. Uber (UBER) and Lyft (LYFT) upgraded to Buy from Hold at HSBC. 3. Schlumberger (SLB) upgraded to Overweight from Equal Weight at Barclays with analyst J. David Anderson saying new CEO Olivier Le Peuch "hit all the right notes" as he repositions the company to succeed in a lower growth environment. 4. RE/MAX Holdings (RMAX) upgraded to Outperform from Market Perform at JMP Securities. 5. Esperion (ESPR) upgraded to Neutral from Sell at Goldman Sachs with analyst Paul Choi saying he now sees less risk of the launch performance of bempedoic acid disappointing over the intermediate term since 2019-2022 consensus revenue estimates have come down "meaningfully." This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/18/19
STFL
09/18/19
NO CHANGE
Target $70
STFL
Buy
Stifel cuts Esperion target to $70, sees entry point after selloff
Stifel analyst Derek Archila lowered his price target for Esperion Therapeutics to $70 from $112 to reflect more conservative assumptions but reiterates a Buy rating on the shares. Even with more conservative forecasts, Esperion is undervalued at these levels, Archila tells investors in a research note. He thinks the stock continues to reflect investor skepticism on the commercial opportunity for bempedoic acid and the company's cash runway. The analyst views bempedoic acid as a "clinically de-risked asset" with two upcoming PDUFA's in February 2020 and believes the cardiovascular outcomes trial design portends a high probability of success. Archila sees a nice entry point into Esperion following the recent selloff and is a buyer of the stock at current levels.
09/26/19
SBSH
09/26/19
NO CHANGE
SBSH
Esperion an attractive buy ahead of bempedoic acid decision, says Citi
Citi analyst Joel Beatty says Esperion Therapeutics remains an attractive stock to own for investors with both short and long investment horizons ahead of the bempedoic acid FDA action dates in February. The analyst has a "high conviction in the approval of bempedoic acid and sees 20% share upside on the news. For investors with longer horizons, Esperion "remains very attractive commercially" at its current $700M enterprise value, contends Beatty. He keeps a Buy rating on the shares with a $73 price target.

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