EWTX Stock Down 48% in a Week Despite Upbeat Cardiomyopathy Study Data

Shares of Edgewise Therapeutics (EWTX Quick QuoteEWTX – Free Report) plunged 47.7% in a week, likely due to safety concerns for its investigational candidate, EDG-7500, in patients with obstructive or nonobstructive hypertrophic cardiomyopathy (HCM), despite positive mid-stage study results.

EWTX is evaluating EDG-7500, a novel oral, selective, cardiac sarcomere modulator with a unique mechanism of action, in the ongoing phase II CIRRUS-HCM study. The latest data readout is from Part B and Part C of the CIRRUS-HCM study, which included 17 patients with obstructive HCM and 12 with nonobstructive HCM, respectively. Both parts evaluated the safety and efficacy of once-daily 50 or 100-mg doses of the candidate for four weeks.

Detailed Results From Parts B & C of EWTX’s CIRRUS-HCM Study

In patients with obstructive HCM, Edgewise Therapeutics reported that treatment with EDG-7500 demonstrated meaningful, dose-dependent reductions in left ventricular outflow tract gradient (LVOT-G) both at rest and post-Valsalva. At the 100 mg dose, patients experienced a 71% reduction in resting gradients and a 58% reduction in provokable gradients without significant changes in left ventricular ejection fraction (LVEF).

EWTX’s shares have plummeted 56.9% year to date against the industry’s 7.3% decline.

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Additionally, Edgewise Therapeutics announced that NT-proBNP levels, a key heart failure biomarker, showed a 62% mean reduction. Positive trends in diastolic function parameters were observed, along with clinically significant improvements in patient-reported outcomes. The Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) increased by an average of 23 points at the 100 mg dose, and 78% of patients showed an improvement of at least one NYHA functional class, with 67% reaching Class I (asymptomatic).

In participants with nonobstructive HCM, EDG-7500 also led to dose-dependent reductions in NT-proBNP, with a 42% decrease at the 100 mg dose. Improvements in diastolic function were observed as early as one week, and substantial gains were recorded in patient-reported measures, with KCCQ-OSS and KCCQ-Clinical Summary Scores increasing by 17 and 22 points, respectively, after four weeks. Importantly, these benefits were also achieved without significant reductions in LVEF, with no participant recording an LVEF below 50% at any time point.

Edgewise Therapeutics further reported that adverse events related to treatment with the candidate were mostly mild to moderate in severity. However, two patients experienced serious adverse events of atrial fibrillation that required cardioversion. Additionally, one participant discontinued treatment due to moderate dizziness. Such safety issues have disappointed investors, which likely caused the stock price to decline in the past week.

EWTX had reported positive top-line data from Part A of the CIRRUS-HCM study in 2024. Per the data readout, a single oral dose of EDG-7500 in obstructive HCM patients resulted in significant reductions in LVOT-G without notable changes in LVEF.

Based on the findings to date, Edgewise Therapeutics is optimizing its dosing strategy in Part D of the CIRRUS-HCM study in patients with obstructive and nonobstructive HCM. Initial Part D data readout is expected in the second half of 2025. The company is also planning to initiate a late-stage study of EDG-7500 for the HCM indications in the first half of 2026.

EWTX’s Competition in Target Market

Cytokinetics (CYTK Quick QuoteCYTK – Free Report) is a potential competitor for Edgewise Therapeutics in the market for HCM drugs. A regulatory filing seeking the approval of CYTK’s lead candidate in the cardiac muscle contractility program, aficamten, for obstructive HCM is currently under review in the United States. It is a novel, oral, small-molecule cardiac myosin inhibitor.

A decision from the FDA is expected on Sept. 26, 2025. A potential approval will allow Cytokinetics to capture market share as EWTX’s candidate is still in clinical development. CYTK has also submitted a 120-day safety update to the FDA for the aficamten filing with an additional 10 months of safety data arising from FOREST-HCM, the open-label extension study of aficamten in patients with HCM. A similar filing is also currently under review in the EU and China.

The FDA has granted orphan drug designation to Cytokinetics’ aficamten for the treatment of symptomatic HCM and Breakthrough Therapy designation for the treatment of obstructive HCM.

EWTX’s Zacks Rank & Stocks to Consider

Edgewise Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Bayer (BAYRY Quick QuoteBAYRY – Free Report) and ADMA Biologics (ADMA Quick QuoteADMA – Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.15 to $1.19 for 2025. During the same time, earnings per share have increased from $1.24 to $1.28 for 2026. Year to date, shares of Bayer have gained 12.7%.

BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.

In the past 30 days, the estimate for ADMA Biologics’ 2025 earnings per share has increased from 70 cents to 71 cents. The estimate for 2026 earnings per share has remained constant at 93 cents. Year to date, shares of ADMA Biologics have gained 5%.

ADMA’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 32.8%.