Esperion: "Hitting on all Cylinders"
The FDA has confirmed that the bempedoic acid Phase III development program is adequate to support an approval prior to their cardiovascular outcome trials (CVOT) results.
The news is lifting one of the largest overhangs on the stock, and creating a clear path to an earlier-than-expected approval.
The uncertainty regarding the FDA’s willingness to approve new drugs to treat chronic disease before delivering outcomes data had represented a major overhang on ESPR shares and has now been removed.
In our view, the re-emergence of lowering LDL as the gold standard to treat (and even prevent) heart disease is great news for ESPR as they have the most advanced drug in development in the space.
The Phase III clinical development program is spearheaded by a global pivotal 52-week long-term safety and tolerability study in patients with hypercholesterolemia at high CVD risk and whose LDL-C is not adequately controlled with current lipid-modifying therapies.
Patient enrollment of more than 2,200 patients was completed in January 2017 and top-line results from this study are expected by the second quarter of 2018.
Furthermore, with the company’s broad Phase III program, called CLEAR, top-line results from the three LDL-C lowering efficacy studies expected by mid-2018.
Importantly, ESPR and the FDA have also reached an agreement on the definition of statin intolerance for their CVOT, eliminating another source of uncertainty for investors.
The company is uniquely positioned heading into Phase III readouts starting about a year from now as there are almost no competitors in the oral cholesterol space due to the previous unknowns regarding CVOT requirements.
With the right drug candidate, experienced management and a clear regulatory path, in our view, ESPR is poised for further growth despite its recent gains.
As a reflection of the drug’s increased potential due to improved FDA regulatory clarity and competitive profile, we are raising our buy price from $28 to $40 per share.
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