The FDA has accepted both New Drug Applications from Esperion (ESPR) for bempedoic acid and the bempedoic acid/ezetimibe combination tablet for filing and regulatory review, reports John McCamant, biotech specialist and editor of The Medical Technology Stock Letter.
Bempedoic acid (BA) is an oral, once-daily ATP citrate lyase (ACL) inhibitor that reduces cholesterol and fatty acid synthesis in the liver.
While we expected the NDAs to be accepted on time, the lack of the need for an Advisory Panel is another major positive that, we believe, will stop the bears/manipulators for making subjective inferences that often occurs when AdComs are announced and briefing docs are released.
More from John McCamant: Esperion Gets a Go-Ahead from the FDA
Also, in our view, it strongly suggests that the company has provided the agency with everything it needs to make a decision.
Lastly, we believe that decision will be one of FDA approval come next February. With a low market cap of $1.3 billion and more than 20% of the stock shorted, in our view, there will be no more negative clinical and/or regulatory events in the foreseeable future.
This is simple and straightforward:
PDUFA Dates Set – The PDUFA dates are February 20, 2020 for BA mono therapy and February 26, 2020 for the BA/ezetimibe combination, respectively.
No Panel Necessary For Decision – The FDA also communicated there is no current plan to hold an advisory committee meeting to discuss the applications – certain bears believed that an AdCom would need to be called to discuss potential adverse events from the clinical trials. Based upon the above guidance by the FDA, that will not be necessary.
Esperion will to host Analyst and Investor Day on May 30th, An upcoming milestone for the third quarter will be the completion of enrollment in the 12,604 patient CLEAR Cardiovascular Outcomes study
Milestones for the second half of 2019 are top-line results from the 12-week, Phase 2 clinical study (1002-058) of the bempedoic acid and ezetimibe combination tablet in 242 patients with elevated LDL-C and type 2 diabetes mellitus and the pivotal Phase 3 trial initiation of bempedoic acid in patients with elevated LDL-C and type 2 diabetes, to support a glycemic control indication in adults with both hypercholesterolemia and type 2 diabetes mellitus.
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Bempedoic acid and the bempedoic acid / ezetimibe combination tablet were developed to be complementary, cost-effective, convenient, once-daily, oral therapies for the treatment of patients with elevated low-density lipoprotein cholesterol (LDL-C) who need additional LDL-C lowering despite the use of currently accessible therapies.
In our view, the combination of today’s positive FDA news and ESPR’s successful clinical development program, five studies totaling ~4,000 patients, four for BA and one for the BA/EZ combination tablet, has significantly de-risked the stock.
The drug is expected to be the first non-statin pill approved for cholesterol reduction – and in statin-resistant patients — a market that we believe is significantly underestimated by Wall Street and hence, ESPR’s share price. We reiterate our buy rating.
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