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ESPR Nexletol - Stock back after Clear Outcomes data?

Summary:

  • Esperion CLEAR outcomes data came out Dec 7

  • This was a month early and stock did not react well (down 15% on 12/7 and 32% that week)

  • Since then stock back up 27%

  • AMRN and ARWR also have assets in cardiovascular indications

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NEXLETOL CLEAR Outcomes trial reported 12/7/22, a month earlier than expected (previously identified as a January 2023 Suspected Mover to Watch). This data surprisingly came early and unfortunately the market did not react well.

This likely was the quietest lead asset Outcomes trial readout for biopharma! Nexletol (bempedoic acid) is used to lower LDL-C and the CLEAR outcomes trial was to assess major adverse cardiovascular events.


ESPR stock was down almost 15% upon announcement of this data (and down 32% by the end of that week) even though the primary endpoint was met. This was due to market suspicion from the minimal readout. This trial became the first oral non-statin and ATP citrate lyase inhibitor to meet the MACE-4 (major adverse cardiovascular events) primary endpoint. This primary endpoint was to demonstrate risk reduction in MACE-4 in patients treated with 180mg/day bempedoic acid (Nexletol) compared to placebo.




 

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See the full CLEAR Outcomes trial design of the clinical trial: https://clinicaltrials.gov/ct2/show/NCT02993406


Trial design:

  • Either 180mg Bempedoic tablet daily or placebo tablet daily

  • Primary outcome measures: "Time from randomization to first occurrence of one of the following adjudicated composite endpoints: CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization. [ Time Frame: 3.75 years (estimated average treatment duration) ]" from https://clinicaltrials.gov/ct2/show/NCT02993406

  • Patients in this trial were between 18 and 85 years, are at high risk for cardiovascular disease (CVD), history of statin intolerance, and have a fasting blood LDL-cholesterol >100 at screening.


Since the fall in early December, ESPR stock has rebounded +27%. ESPR is now a Suspected Mover for March when data is presented at ACC.23 in March. The American College of Cardiology (ACC) is partnering with the World Heart Federation to host ACC.23 and ESPR CLEAR Outcomes was accepted as a late-breaking clinical trial presentation.


Several other smid-cap biopharma companies focus on cardiology indications including AMRN and ARWR. The AMRN asset Vascepa is approved for cardiovascular disease and the ARWR asset ARO-ANG3 is in Phase 2 studies for dyslipidemia (abnormal cholesterol levels). AMRN stock is up 10.3% since December 7 and ARWR stock is up 16.3% since December 7.



It will be interesting to see how stocks react in March when ESPR data is presented at ACC.23 and when ARO-ANG3 Ph2 data is reported in the first half of next year.



 

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