Esperion Therapeutics Downgraded On Regulatory Concerns By Credit Suisse

Credit Suisse’s Vamil Divan expressed concern regarding the outlook for bempedoic acid in the U.S. market, following the update provided by Esperion Therapeutics Inc ESPR regarding the its development plans for the product.

Divan downgraded the rating on the company from Neutral to Underperform, while lowering the price target from $23 to $10.

Regulatory Concerns

“We are surprised that the FDA may not be willing to allow LDL-C as a surrogate endpoint for initial approval but believe there will be significant pressure (and limited upside) on ESPR shares until that certainty is obtained, and that process may take years to play out,” the analyst mentioned.

Divan had expected the FDA’s support the LDL-hypothesis to allow for the approval of bempedoic acid before the completion of a cardiovascular outcome trial.

“With a "potentially evolving landscape" now calling that into question, we wonder on the path, timeline and cost to ultimate US approval, as well as how the competitive environment will look if/when bempedoic acid makes it there,” the analyst stated.

The analyst believes that the timeframe for the initial FDA submission could be pushed out to 2022 if the results of the CLEAT Outcomes trial were required prior to submission.

This is well beyond the early-2019 timeframe through which Divan expects Esperion Therapeutics’ current cash resources to fund the company’s operations.