EWTX - Defending the stock: EDG-7500 potential for REMS-free alternative to CMI remains

研报英文原文证据摘录

EWTX - Defending the stock: EDG-7500 potential for REMS-free alternative to CMI remains

Range $40.26-$12.61 show no LVEF < 50% at any dose tested (range 25-mg up to 300-mg). Data from the call

Market Cap ($M) $3,767 also show no change to Global Longitudinal Strain (GLS) and Global Circumferential Strain

ADTV 814,065 (GCS), a measure of systolic mechanics, after EDG-7500 administration that is outside the

Shares Out (M) 107 range seen with placebo. We believe the observed lack of systolic effect supports the

Short Interest Ratio/% Of Float 13.9% potential for ECHO-independent treatment that could lead to a REMS-less treatment

Enterprise Value ($M) $1,717 protocol with EDG-7500.

Cash & Equivalents ($M) $2,050 On atrial fibrillation, 2 patients (3.8%; both oHCM) had new onset AF/AFL, with both AF

instances deemed unrelated to the study drug by the trial's principal investigator (PI). For

6 Page Document more color on the PIs decision, the PIs were allowed to use their clinical judgment and

relatedness to make this decision. The patients had atrial fibrillation (AF) risk calculators that

were utilized as part of standard of care with these oHCM patients ranking as both very high

Reasons for this report to high. Both patients had very robust improvements in treatment. Overall, the PI thought

that the overall background disease rate was more likely driving the AF than EDG-7500.

✓ Management Call Takeaways EWTX has said that they have done extensive work looking at dose-exposure relationships

and temporal relationships, and they were unable to find any convincing connection between

EDG-7500 and the risk of AF. We remind investors that AF was seen in all the prominent

CMI trials.

On KCCQ, Edgewise reported a mean improvement of 24-points KCCQ-OSS and 19.6-