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

Esperion Therapeutics Inc 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 REGN, Amgen, Inc. AMGN, Novartis AG (ADR) 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.

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