Guggenheim Grand Rounds: Discussing the EDG-7500 CIRRUS Part D Data — Perspectives from a Physician with ~2,000 HCM Patients

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Guggenheim Grand Rounds: Discussing the EDG-7500 CIRRUS Part D Data — Perspectives from a Physician with ~2,000 HCM Patients

WTX can credibly take the safety story to the FDA, and potentially circumvent

REMS, which could be commercially very impactful.

The supporting strain data — global circumferential and longitudinal strain unchanged on

treatment — are reassuring but, in Dr. Abraham's view, not independently differentiating. He

notes that aficamten and the mavacamten dataset both showed preserved strain despite a

5–6 point EF drop, a finding he describes as discordant with the cardio-oncology literature,

where strain typically falls earlier and more steeply than EF. The unresolved mechanistic

question — why strain is preserved when EF drops on CMIs — carries over to EDG-7500,

so while the flat EF curve does separate -7500 from the CMIs, the strain data do not, per

Dr. Abraham.

On AFib, the Part D titration protocol appears to have materially reduced event rates, from

the ~14% range seen in Parts B/C down to ~3.7% (all deemed unrelated to treatment) in

the 53-patient Part D cohort. Dr. Abraham views this as a critical de-risking event for -7500,

because consistently elevated AFib risk could have been a downside versus CMIs. As with

EF, the open question remains durability at scale: Dr. Abraham wants to see whether the

AFib rate observed in CIRRUS Part D holds across a Phase 3 population with potentially

greater comorbidity burden. However, in his view, CIRRUS Part D's more gentle up-titration

protocol may have genuinely solved the AFib problem rather than masked it.

REMS: the variable that defines the commercial opportunity

Dr. Abraham framed the REMS outcome as the single largest swing factor for EDG-7500's

commercial profile.