Edgewise Therapeutics, Inc. Stock Price, News & Analysis

Edgewise Therapeutics (NASDAQ: EWTX) announced positive topline results from its Phase 2 CANYON trial of sevasemten in Becker muscular dystrophy patients. The trial met its primary endpoint with a significant 28% reduction in creatine kinase levels, a biomarker of muscle damage. The key secondary endpoint showed stabilization in North Star Ambulatory Assessment (NSAA) scores, with a trend toward improvement compared to placebo.

The study, involving 40 adults and 29 adolescents, demonstrated sevasemten was well-tolerated with no new safety concerns. Additional functional measures showed positive trends, and 99% of eligible participants enrolled in the MESA open-label extension trial. The company plans to complete recruitment for the GRAND CANYON pivotal cohort by Q1 2025 and will engage with FDA and EMA regarding marketing authorization strategies.

Edgewise Therapeutics (Nasdaq: EWTX) has issued a statement clarifying its relationship with Dr. Han Phan at Rare Disease Research following an FDA warning letter. The company emphasized that the FDA's warning letter to Dr. Phan, issued on November 27, 2024, was based on her work with another company and is completely unrelated to any Edgewise clinical trials or data.

The company has conducted multiple audits of Dr. Phan's site and confirms that data from Edgewise clinical trials are being collected and stored in compliance with FDA requirements.

Edgewise Therapeutics (Nasdaq: EWTX), a muscle disease biopharmaceutical company, has announced its upcoming participation at the Piper Sandler 36th Annual Healthcare Conference. The presentation is scheduled for Tuesday, December 3, 2024, at 1 pm ET.

The event will feature a live webcast accessible through the company's Events & Presentations page. Viewers are advised to connect several minutes before the start time to ensure proper connection. The webcast recording will be available for replay for a period after the conference.

Edgewise Therapeutics (EWTX) reported Q3 2024 financial results and updates on its clinical programs. The company maintains a strong cash position of $492.5 million as of September 30, 2024. Q3 net loss was $34.1 million ($0.36 per share), compared to $31.5 million in Q2. R&D expenses increased to $32.2 million from $30.7 million in Q2.

The company is advancing multiple Phase 2 trials: CANYON for Becker muscular dystrophy (top-line results expected December 2024), LYNX and FOX for Duchenne muscular dystrophy, and CIRRUS-HCM for hypertrophic cardiomyopathy. Positive Phase 1 data was reported for EDG-7500 in healthy subjects and Phase 2 CIRRUS-HCM trial in obstructive HCM patients.

Edgewise Therapeutics (Nasdaq: EWTX) announced its participation at the 29th International Annual Congress of the World Muscle Society in Prague, October 8-12, 2024. The company will present an industry-sponsored symposium and seven scientific posters highlighting the effects of sevasemten in individuals with Becker muscular dystrophy.

The symposium, titled 'Understanding disease progression and a potential novel agent to protect muscle,' will feature key opinion leaders and discuss positive two-year topline results from the ARCH trial. The scientific posters will cover topics such as reduced muscle damage biomarkers, functional stabilization, and proteomic responses to sevasemten in Becker muscular dystrophy patients.

Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in muscular dystrophies. The presentations will provide insights into biomarker and functional endpoints being studied in the CANYON Phase 2 trial.

Edgewise Therapeutics (Nasdaq: EWTX) announced positive top-line data for EDG-7500, a novel oral cardiac sarcomere modulator, from its Phase 1 trial in healthy subjects and Phase 2 CIRRUS-HCM trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Key findings include:

1. Phase 1: EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF).
2. CIRRUS-HCM: Single-dose trial demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without significant LVEF changes.
3. 67% mean reduction in resting LVOT pressure gradient and 55% mean reduction in provokable LVOT gradient observed at 100 and 200 mg doses.
4. 64% mean reduction in NT-proBNP, a key heart failure biomarker, in the 200 mg cohort.

The company has initiated the 28-day part of CIRRUS-HCM in patients with obstructive and non-obstructive HCM, with initial data expected in Q1 2025.

Edgewise Therapeutics (Nasdaq: EWTX) has announced a live webcast scheduled for September 19, 2024, at 8:30 am ET to discuss top-line data of their drug EDG-7500. The presentation will cover results from two trials:

1. The Phase 1 trial in healthy subjects
2. The single-dose arm of the Phase 2 CIRRUS-HCM trial in patients with obstructive Hypertrophic Cardiomyopathy (HCM)

Dr. Anjali T. Owens, Medical Director at the Center for Inherited Cardiac Disease and Associate Professor of Medicine at the University of Pennsylvania, will join the management team to share her perspective on EDG-7500 and HCM. Interested parties can register for the webcast and access the accompanying slide presentation through the Edgewise events page.

Edgewise Therapeutics (Nasdaq: EWTX) reported Q2 2024 financial results and business highlights. Key developments include:

1. Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers

2. Dosing patients in Phase 2 CIRRUS-HCM trial of EDG-7500 for obstructive HCM

3. Advancing GRAND CANYON global pivotal cohort of sevasemten in adults with Becker muscular dystrophy

4. Progressing Phase 2 LYNX and FOX trials of sevasemten in children with Duchenne muscular dystrophy

5. Q2 2024 financial results: $511.8M cash and equivalents, R&D expenses $30.7M, G&A expenses $7.4M, net loss $31.5M ($0.34 per share)

The company expects to present topline data for EDG-7500 from Phase 1 and CIRRUS-HCM Part A in September 2024.

Edgewise Therapeutics, Inc. (Nasdaq: EWTX) will present at the RBC Capital Markets Global Healthcare Conference on May 15, 2024, at 3:35 pm ET. The presentation will be webcast live and a replay will be available. Users should connect early for a timely connection.