Why Is Edgewise Therapeutics Stock Soaring Wednesday?

by | Dec 24, 2025 | General

Edgewise Therapeutics Inc. (NASDAQ:EWTX) on Wednesday shared updates from the ongoing CIRRUS-HCM Phase 2 trial of EDG-7500.

EDG-7500 is an oral cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with hypertrophic cardiomyopathy (HCM) without impacting systolic function.

Earlier this year, the company reported topline results from the Part B (oHCM, n=17) and Part C (nHCM, n=12) 50 mg and 100 mg fixed dose cohorts.

Also Read: No Accelerated FDA Approval For Edgewise’s Rare Muscular Disease Drug; Shares Fall

In addition to the 50 mg and 100 mg fixed doses previously reported, the company evaluated a lower 25 mg fixed dose in 4 oHCM and 10 nHCM participants in CIRRUS-HCM Parts B and C, respectively.

In these cohorts, evidence of clinical activity was observed across key HCM disease markers, while maintaining a favorable safety profile, with no clinically meaningful changes in left ventricular ejection fraction (LVEF) or reductions in LVEF to below <50% and no events of atrial fibrillation (AF).

The CIRRUS-HCM Part B and C cohorts have completed dosing, with a total of 43 participants enrolled across all dose groups.

CIRRUS-HCM Part D is designed to explore exposure-response correlations, assess biomarker-guided dose optimization to inform the design of Phase 3 trials, and support regulatory discussions.

In this interim safety update, for the 20 participants who completed 12 weeks of dosing in Part D as of the data cutoff date (8 with oHCM and 12 with nHCM), EDG-7500 generally had a favorable safety profile and was well tolerated.

Consistent with previous observations, no clinically significant changes in LVEF or reductions in LVEF to below 50% were observed, with EDG-7500 continuing to demonstrate a differentiated LVEF profile relative to CMIs.

The safety profile observed with EDG-7500 to date, across both healthy volunteers and the CIRRUS-HCM trial, supports the potential use of EDG-7500 in diverse HCM patient populations.

The company remains on track to deliver comprehensive efficacy and safety data from Part D of the CIRRUS-HCM trial in the second quarter of 2026 and is advancing Phase 3 trial design in preparation for trial initiation by the end of 2026.

Competitive Landscape

Earlier this week, the U.S. Food and Drug Administration (FDA) approved Cytokinetics Incorporated’s (NASDAQ:CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

EWTX Price Action: Edgewise Therapeutics shares were up 17.96% at $25.65 at the time of publication on Wednesday, according to Benzinga Pro data.

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