Market Overview

Esperion Shares Plunge After Cholesterol-Lowering Drug's Phase 3 Results Stir Safety Concerns

Share:
Esperion Shares Plunge After Cholesterol-Lowering Drug's Phase 3 Results Stir Safety Concerns
Related ESPR
The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Results
The Week Ahead In Biotech: Conferences, PDUFA Dates And Earnings

Esperion Therapeutics Inc (NASDAQ: ESPR) shares are in free fall Wednesday after the company reported first-quarter results and gave an update on its bempedoic acid franchise development program.

The stock was down 26.25 percent to $51.99 at time of publication.

What Happened

Esperion, which specializes in developing therapies for patients with elevated LDL cholesterol, reported a wider-than-expected loss of $1.73 per share in Q1 against a consensus estimate of $1.56 — although the loss was narrower than a year ago.

The company announced positive top-line results from its second pivotal Phase 3 study that evaluated the long-term safety of bempedoic acid at a 180 mg dose. 

The pipeline candidate achieved additional 20 percent on-treatment LDL cholesterol lowering at week 12, and additional hsCRP reduction of 22 percent on background maximally tolerated statin therapy.

Although adverse events and rates of serious adverse events were comparable between the treatment group and placebo, the treatment group saw 13 deaths compared to two in the control group.

Why It's Important

The results are important, as there are competitors in the race for a breakthrough for the indication, including Regeneron Pharmaceuticals Inc (NASDAQ: REGN), Amgen, Inc. (NASDAQ: AMGN), Novartis AG (ADR) (NYSE: NVS) and others. 

"ESPR Study 1 demonstrates clean safety profile and robust efficacy with early signal of benefit in adjudicated CV events," JMP Securities said of the data. 

"We firmly agree with management's perspective that the fatalities seen in Study 1 were not related to study drug (0.9 percent on bempedoic acid vs. 0.3 percent on placebo)."

What's Next

Esperion said it expects to submit a NDA for bempedoic acid and the combo pill no later than the first quarter of 2019. The company also intends to submit marketing authorization applications to the European Medicines Agency no later than the second quarter of 2019.

Related Links:

Benzinga's Daily Biotech Pulse: SIGA Rallies On FDA Panel Backing, Rigel And Gilead React To Earnings

The Week Ahead In Biotech: PDUFA Dates, Clinical Trials, Merck And Pfizer Earnings On Tap

Latest Ratings for ESPR

DateFirmActionFromTo
Aug 2018CitigroupUpgradesNeutralBuy
Jul 2018Northland SecuritiesDowngradesOutperformMarket Perform
May 2018Credit SuisseMaintainsOutperformOutperform

View More Analyst Ratings for ESPR
View the Latest Analyst Ratings

Posted-In: JMP SecuritiesBiotech Earnings News Top Stories Analyst Ratings Trading Ideas Best of Benzinga

 

Related Articles (AMGN + ESPR)

View Comments and Join the Discussion!

Sterling Set To Ease Of Transition Period Euphoria

Under Armour's Existential Crisis: Niche Player Or Global Competitor?