Edgewise Therapeutics Announces Positive Top-Line Data from 12-Week Phase 2 CIRRUS-HCM Trial with EDG-7500 in Obstructive and Nonobstructive Hypertrophic Cardiomyopathy (HCM)

Rhea-AI Summary

Edgewise Therapeutics (Nasdaq:EWTX) reported positive 12-week Phase 2 Part D CIRRUS-HCM data for EDG-7500 in obstructive and nonobstructive hypertrophic cardiomyopathy.

Patients showed improvements in LVOT gradient, NT-proBNP, KCCQ scores, NYHA class and diastolic parameters, with no LVEF reductions below 50% and generally well-tolerated safety, supporting Phase 3 initiation targeted for Q4 2026.

Positive

• In oHCM, 90% of patients improved in hemodynamic LVOT-G measures
• In oHCM, 74% achieved NT-proBNP normalization or ≥50% reduction
• In nHCM, ~65% mean NT-proBNP reduction; 88% met key NT-proBNP response
• KCCQ-OSS improved by 24 points in oHCM and 13 points in nHCM
• NYHA class improved by at least one class in 70% oHCM and 64% nHCM patients
• No LVEF reductions below 50% across Part D; EDG-7500 generally well tolerated
• Data support advancing EDG-7500 into Phase 3, targeted to start Q4 2026

Negative

• None.

News Market Reaction – EWTX

-3.58%

23 alerts

-3.58% Session close to close

+7.7% Peak Tracked

-33.4% Trough Tracked

$3.82B Market Cap

0.3x Rel. Volume

In the Jun 16 session, EWTX declined 3.58%, reflecting a moderate negative market reaction. Argus tracked a peak move of +7.7% during that session. Argus tracked a trough of -33.4% from its starting point during tracking. Our momentum scanner triggered 23 alerts that day, indicating elevated trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reports 12-week Phase 2 CIRRUS-HCM data for EDG-7500 showing broad improvements in...

Analysis

This announcement reports 12-week Phase 2 CIRRUS-HCM data for EDG-7500 showing broad improvements in NT-proBNP, KCCQ, NYHA class and diastolic measures across obstructive and nonobstructive HCM, with no LVEF reductions below 50%. Historically, Edgewise’s clinical readouts have produced sizeable price moves, both up and down. Investors may track the planned Phase 3 initiation in Q4 2026, long-term safety, and how this cardiovascular focus builds on the recently announced Servier transaction.

Key Figures

Part D patients: 53 patients oHCM hemodynamic improvement: 90% of patients oHCM NT-proBNP response: 74% of patients +5 more

8 metrics

Part D patients 53 patients Completed 12-week Phase 2 CIRRUS-HCM Part D cohort

oHCM hemodynamic improvement 90% of patients oHCM group with improvement in hemodynamic measures

oHCM NT-proBNP response 74% of patients Achieved NT-proBNP normalization or ≥50% reduction in oHCM

oHCM KCCQ-OSS 24-point mean increase Change in KCCQ Overall Summary Score for oHCM at 12 weeks

oHCM NYHA improvement 70% of patients At least one class improvement in NYHA in oHCM

nHCM NT-proBNP reduction ≈65% mean reduction Mean NT-proBNP decrease in nHCM at 12 weeks

nHCM KCCQ-OSS 13-point mean increase Change in KCCQ Overall Summary Score for nHCM at 12 weeks

nHCM e' lateral 37% mean increase Increase in early diastolic mitral annular velocity in nHCM

Previous Clinical trial Reports

4 past events · Latest: Dec 24 (Positive)

Same Type Pattern 4 events

Date	Event	Sentiment	24h Move	Catalyst
Dec 24	EDG-7500 Part D interim	Positive	+25.5%	Completion of CIRRUS-HCM Parts B/C and favorable interim Part D safety.
Apr 02	EDG-7500 4-week data	Positive	-22.9%	Positive four-week CIRRUS-HCM efficacy in HCM with strong biomarker changes.
Dec 16	Sevasemten Phase 2 data	Positive	+18.4%	CANYON Phase 2 Becker data meeting primary endpoint with safety support.
Sep 19	EDG-7500 Phase 1/2 data	Positive	+54.7%	Phase 1 and early CIRRUS-HCM results with large LVOT and NT-proBNP reductions.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical-trial updates have generally triggered strong positive moves for EWTX, with one notable negative reaction despite positive data.

Recent Company History

Over the past 18 months, Edgewise has repeatedly reported positive clinical data across muscle and cardiac programs. EDG-7500 CIRRUS-HCM updates on Sep 19, 2024, Apr 2, 2025, and Dec 24, 2025 all highlighted robust LVOT gradient and NT-proBNP improvements with preserved LVEF. These events drove sizeable price moves, including a 54.69% gain and a 25.5% gain, but also a -22.9% decline after positive four-week results. Today’s 12‑week Part D readout extends that efficacy and safety story toward Phase 3 planning.

Key Terms

left ventricular ejection fraction (LVEF), LVEF, left ventricular outflow tract gradient (LVOT-G), N-terminal pro-B-type natriuretic peptide (NT-proBNP), +4 more

8 terms

left ventricular ejection fraction (LVEF) medical

"No relationship observed between EDG-7500 exposure and LVEF; no LVEF reductions below 50%"

Left ventricular ejection fraction (LVEF) is the percentage of blood the heart’s main pumping chamber pushes out with each beat, a simple measure of how effectively the heart pumps like the efficiency rating on a water pump. Investors care because LVEF is a key clinical indicator used to diagnose and guide treatment for heart failure and other cardiac conditions, which affects demand for drugs, devices, reimbursement, trial outcomes, and company valuation.

LVEF medical

"no LVEF reductions below 50%"

Left ventricular ejection fraction (LVEF) is a percentage that measures how much blood the heart’s main pumping chamber pushes out with each beat, like the share of water a pump empties from a bucket each cycle. Investors watch LVEF because it’s a key medical yardstick used to diagnose and track heart function, shaping demand for drugs, devices, clinical trials, insurance costs and the financial outlook of healthcare-related businesses.

left ventricular outflow tract gradient (LVOT-G) medical

"In oHCM, dosing was guided by left ventricular outflow tract gradient (LVOT-G)"

Left ventricular outflow tract gradient (LVOT-G) is a measure of the pressure difference between the heart’s main pumping chamber and the artery that carries blood out to the body, caused when the pathway out of the left ventricle is narrowed or obstructed. Think of it like the pressure build-up before a partially blocked pipe; higher gradients mean more obstruction and symptoms. Investors watch LVOT-G because changes indicate disease severity or treatment benefit, affecting clinical trial results, regulatory decisions, and market demand for therapies or devices.

N-terminal pro-B-type natriuretic peptide (NT-proBNP) medical

"in nHCM, dosing was guided by N-terminal pro-B-type natriuretic peptide (NT-proBNP)"

N-terminal pro-B-type natriuretic peptide (NT‑proBNP) is a protein fragment measured in the blood that rises when the heart is stretched or under stress, acting like a "check‑engine" light for heart function. Investors care because NT‑proBNP levels are used by doctors and regulators to diagnose and monitor heart failure, guide clinical trials, and drive demand for drugs, devices, and laboratory tests — so changes in its use, guidelines, or test availability can affect healthcare revenue and company valuations.

Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) medical

"A 24-point mean increase was reported on the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS)"

A patient-reported number that summarizes how heart failure affects a person’s symptoms, daily activities, and overall quality of life on a 0–100 scale, where higher scores mean better health. Investors use it as a real-world measure of whether a treatment or device actually improves patients’ lives—similar to a customer satisfaction score showing whether a product delivers meaningful benefit and is likely to gain market acceptance and regulatory support.

New York Heart Association (NYHA) functional class medical

"70% of patients exhibited at least one class improvement in New York Heart Association (NYHA) functional class measures"

New York Heart Association (NYHA) functional class is a four-level system doctors use to describe how much a person’s heart condition limits ordinary physical activity, ranging from no symptoms with exertion to symptoms at rest. For investors it signals the severity of heart disease targeted by treatments or devices, influences clinical trial design and regulatory or reimbursement decisions, and helps forecast market size by showing how many patients need more advanced care—think of it as a simple activity “speedometer” for heart failure.

e' lateral medical

"led to a ~20% mean increase in early diastolic mitral annular velocity (e' lateral)"

e' lateral is a specific measurement taken during a heart ultrasound that gauges how quickly the outer edge of the mitral valve ring moves as the left ventricle relaxes between beats. Investors monitor it because changes in this value are used in clinical studies and device evaluations to show improvement or decline in heart relaxation—similar to checking a car’s shock absorbers—and such results can influence regulatory outcomes, clinical adoption and a company’s market value.

atrial fibrillation medical

"There were 2 (3.8%) new onset atrial fibrillation events"

Atrial fibrillation is a common heart rhythm problem in which the heart’s upper chambers quiver instead of delivering steady, strong pumps, like a washing machine on an unbalanced cycle. It matters to investors because it increases use of medications, medical devices, hospital care and long‑term monitoring, drives demand for new treatments and diagnostics, and can affect healthcare costs, regulatory decisions and revenue prospects across drug, device and insurance markets.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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– No relationship observed between EDG-7500 exposure and LVEF; no LVEF reductions below 50% –

– Consistent and clinically meaningful improvements observed in echocardiogram parameters, biomarkers, symptoms and functional status across obstructive and nonobstructive HCM  –

– EDG-7500 administration continued to be generally well tolerated –

– Company to host webcast today at 8:30 a.m. Eastern Time –

BOULDER, Colo., June 16, 2026 /PRNewswire/ -- Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive top-line results from the 12-week Phase 2 Part D CIRRUS-HCM trial of EDG-7500 in obstructive (oHCM) and nonobstructive (nHCM) HCM. EDG-7500 is a novel, oral, selective cardiac sarcomere modulator designed to slow early contraction velocity and improve impaired cardiac relaxation in symptomatic HCM without compromising systolic function. To date, in over 700 echocardiograms performed in healthy adults and patients with HCM, there was no relationship observed between multiple measures of systolic function and concentration of EDG-7500.

CIRRUS-HCM is a multi-part (A-D), open label trial of EDG-7500 in patients with oHCM and nHCM. Part D is a 12-week cohort designed to inform a Phase 3 trial. In oHCM, dosing was guided by left ventricular outflow tract gradient (LVOT-G), while in nHCM, dosing was guided by N-terminal pro-B-type natriuretic peptide (NT-proBNP), a key biomarker of heart failure. Patients in both groups received doses ranging from 25 mg to 150 mg. A total of 53 patients (20 with oHCM and 33 with nHCM) completed Part D 12-week study.

Results in Patients with oHCM
Patients with oHCM receiving EDG-7500 demonstrated broad and clinically meaningful responses across key measures of hemodynamics, biomarkers, patient-reported health status and functional status. Consistent with previous findings, significant reductions in LVOT-G were observed at rest and post Valsalva, with 90% of patients demonstrating improvement in hemodynamic measures. In a key measure of heart failure severity, 74% of patients achieved either normalization of NT-proBNP levels (defined as <150 pg/mL) or a ≥50% reduction from baseline. A 24-point mean increase was reported on the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS), and 70% of patients exhibited at least one class improvement in New York Heart Association (NYHA) functional class measures. In addition, administration with EDG-7500 led to a ~20% mean increase in early diastolic mitral annular velocity (e' lateral), an important marker of diastolic function. In a preliminary high frame rate sub-study, E/e' improved by a mean of 5.3 points, suggestive of markedly improved diastolic function.

Results in Patients with nHCM
Patients with nHCM receiving EDG-7500 demonstrated robust diastolic and symptomatic improvement at 12 weeks. Similar to oHCM, an approximately 65% mean reduction in NT-proBNP was observed in nHCM patients, with 88% of patients achieving normalization or a ≥50% reduction from baseline. A 13-point mean increase in KCCQ-OSS was reported in nHCM patients, and 64% of patients exhibited at least one class improvement in NYHA. In addition, administration with EDG-7500 led to a 37% mean increase in e' lateral. In the same high frame rate sub-study, E/e' improved by a mean of 6.1 points.

Overall Safety
EDG-7500 was generally well tolerated in Part D patients (n=53) and there were no new safety signals identified. Nearly all AEs were considered mild to moderate in severity. There were no meaningful changes in left ventricular ejection fraction (LVEF) or reductions in LVEF to below 50%. There were 2 (3.8%) new onset atrial fibrillation events; both deemed unrelated to study drug by the investigator. 

"From the outset, our goal was to identify a cardiovascular therapy with a profile that avoids the liability of the CMI class, with EDG-7500 emerging from that effort," said Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics. "These Phase 2 data mark an important milestone for Edgewise and the HCM community, reinforcing EDG-7500's unique approach with the potential to address diastolic dysfunction across HCM without meaningful impact on LVEF."

"The totality of the Phase 2 efficacy and tolerability data continues to support a differentiated profile for EDG-7500 across HCM," said Matthew Martinez, M.D., a leading HCM expert and President of the HCM Society. "What is especially encouraging is the consistency of symptom and functional improvement across dose levels without evidence of systolic liability or heart failure risk. The EDG-7500 profile is particularly relevant in nonobstructive HCM, where preserving systolic function while improving relaxation may offer a meaningful new approach to addressing a significant unmet need."

Phase 3 Preparation
Data from CIRRUS-HCM support advancing EDG-7500 into Phase 3 clinical development, with program initiation targeted for the fourth quarter of 2026. 

EDG-7500 Top-line Data Webcast Event

Members of the Edgewise management team will hold a live webcast on Tuesday, June 16, 2026, at 8:30 a.m. ET to discuss the top-line data, and will be joined by leading cardiology experts, Anjali T. Owens, M.D., Medical Director, Center for Inherited Cardiac Disease, Associate Professor of Medicine, in the Perelman School of Medicine at the University of Pennsylvania.  An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit the Edgewise events page.

About CIRRUS-HCM

CIRRUS-HCM is a multi-part, open label trial of EDG-7500 in patients with obstructive and nonobstructive HCM at over 20 clinical sites in the U.S.  Part A of the trial evaluated the safety and tolerability of a single oral dose of EDG-7500 in patients with obstructive HCM (oHCM). Parts B and C evaluated fixed doses of EDG-7500 over 28 days in oHCM and nonobstructive HCM (nHCM), respectively; the results can be found here. Part D is a 12-week study with an open-label extension including patients with oHCM and nHCM designed to explore dose response and optimization. To learn more about CIRRUS-HCM, visit clinicaltrials.gov, NCT06347159.

About Hypertrophic Cardiomyopathy

HCM is the most common form of genetic heart disease, affecting approximately one in 500 people, and is associated with reduced quality of life and an elevated risk of heart failure, abnormal heart rhythms, and sudden cardiac death. Individuals with HCM can become extremely limited in their functional capacity and ability to perform the activities of daily living. Commonly experienced symptoms include breathlessness, irregular heartbeats, chest pain, tiredness, dizziness, or even fainting. These symptoms are caused by excessive contraction and thickening (hypertrophy) of the left ventricular wall of the heart. Over time, the thickened muscle becomes stiff, making it difficult for the heart to relax and fill with blood (diastolic dysfunction). There are two major forms of HCM obstructive and nonobstructive.  Despite advancements in treatment options for some patients with HCM, there remains a significant unmet need for additional therapeutic approaches for patients.

About Edgewise Therapeutics                                                              

Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company's deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of symptomatic hypertrophic cardiomyopathy, currently in Phase 2 clinical development. EDG-15400 is a novel cardiac sarcomere modulator for the treatment of heart failure, currently in Phase 1 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to edgewisetx.com or follow us on LinkedIn, X, Facebook and Instagram.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Statements in this press release that are not purely historical are forward-looking statements.  Such forward-looking statements include, among other things, statements regarding the benefits and potential of, and expectations regarding, EDG-7500; statements regarding the market opportunity for EDG-7500; statements regarding Edgewise's expectations relating to its clinical trials, including timing of the initiation of the Phase 3 trials of EDG-7500; clinical outcomes from trials of EDG-7500, which may materially change as more patient data become available; and statements by Edgewise's President and Chief Executive Officer and the President of the HCM Society.  Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements.  The forward-looking statements contained herein are based upon Edgewise's current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: the potential for the results of the ongoing or any future clinical trial of EDG-7500 to differ from the results of the Phase 2 CIRRUS-HCM trial;  the risk of delays in initiating the planned Phase 3 trials of EDG-7500;  risks associated with Edgewise's limited operating history, its products being early in development and not having products approved for commercial sale; risks associated with Edgewise not having generated any revenue to date; Edgewise's ability to achieve objectives relating to the discovery, development and commercialization of its product candidates, if approved; Edgewise's need for substantial additional capital to finance its operations; Edgewise's substantial dependence on the success of EDG-7500; Edgewise's ability to develop and commercialize EDG-7500; risks related to Edgewise's clinical trials of its product candidates not demonstrating safety and efficacy; risks related to Edgewise's product candidates causing serious adverse events, toxicities or other undesirable side effects; the outcome of preclinical testing and clinical trials not being predictive of the success of later clinical trials and the risks related to the results of Edgewise's clinical trials not satisfying the requirements of regulatory authorities; delays or difficulties in the enrollment and/or maintenance of patients in clinical trials; risks related to failure to capitalize on other indications or product candidates; risks related to competition; risks relating to interim, topline and preliminary data from Edgewise's clinical trials changing as more patient data becomes available; risks related to production of drugs by Edgewise's third-party manufacturers; risks related to changes in methods of product candidate manufacturing or formulation; risks related to not achieving adequate market acceptance; risks related to the regulatory approval processes of domestic and foreign authorities being lengthy, time consuming and inherently unpredictable; risks relating to disruptions at the FDA, the SEC and other government agencies; risks relating to Edgewise's ability to attract and retain highly skilled executive officers and employees; Edgewise's ability to obtain and maintain intellectual property protection for its product candidates; Edgewise's reliance on third parties; risks related to general economic and market conditions; and other risks.  Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission.  These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

 

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SOURCE Edgewise Therapeutics

FAQ

What did Edgewise Therapeutics (EWTX) announce about the Phase 2 CIRRUS-HCM trial on June 16, 2026?

Edgewise Therapeutics announced positive top-line 12-week Phase 2 Part D CIRRUS-HCM results for EDG-7500 in obstructive and nonobstructive HCM. According to Edgewise Therapeutics, patients showed improvements in hemodynamics, biomarkers, symptoms, and functional status, with a generally well-tolerated safety profile and preserved left ventricular ejection fraction.

What were the key Phase 2 CIRRUS-HCM results for EDG-7500 in obstructive HCM (EWTX)?

In obstructive HCM, EDG-7500 led to significant LVOT gradient reductions and broad clinical improvements. According to Edgewise Therapeutics, 90% improved in hemodynamic measures, 74% met NT-proBNP response criteria, KCCQ-OSS increased by 24 points, and 70% improved by at least one NYHA class.

How did EDG-7500 perform in nonobstructive HCM patients in the CIRRUS-HCM Phase 2 trial for EWTX?

Nonobstructive HCM patients experienced robust diastolic and symptomatic improvements at 12 weeks with EDG-7500. According to Edgewise Therapeutics, NT-proBNP fell by about 65% on average, 88% met NT-proBNP response criteria, KCCQ-OSS rose 13 points, and 64% improved by at least one NYHA class.

What do the CIRRUS-HCM Phase 2 safety data show for EDG-7500 and EWTX investors?

EDG-7500 was generally well tolerated in the 53 Phase 2 Part D patients, with no new safety signals. According to Edgewise Therapeutics, nearly all adverse events were mild or moderate, no meaningful LVEF changes occurred, and no LVEF values fell below 50%.

How did EDG-7500 affect diastolic function markers like e' lateral in the CIRRUS-HCM Phase 2 trial (EWTX)?

EDG-7500 improved diastolic function markers in both obstructive and nonobstructive HCM. According to Edgewise Therapeutics, e' lateral increased by about 20% in obstructive HCM and 37% in nonobstructive HCM, with E/e' reductions of 5.3 and 6.1 points respectively in a high frame rate sub-study.

What are the next development steps for EDG-7500 after the CIRRUS-HCM Phase 2 data for Edgewise Therapeutics (EWTX)?

The company plans to advance EDG-7500 into Phase 3 clinical development based on CIRRUS-HCM results. According to Edgewise Therapeutics, Phase 3 program initiation is targeted for the fourth quarter of 2026, aiming to further evaluate efficacy and safety in hypertrophic cardiomyopathy.

How can investors access the June 16, 2026 EDG-7500 top-line data webcast from Edgewise Therapeutics (EWTX)?

Investors can access a live and replay webcast discussing EDG-7500 Phase 2 top-line data via the Edgewise events page. According to Edgewise Therapeutics, the webcast is scheduled for Tuesday, June 16, 2026, at 8:30 a.m. Eastern Time with an accompanying slide presentation.