Edgewise Therapeutics

Edgewise Therapeutics, Inc. is a clinical-stage biopharmaceutical company. It focuses on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Its platform utilizes custom-built throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. The company was founded by Badreddin Edris, Alan Russel and Peter A. Thompson in 2017 and is headquartered in Boulder, CO.

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BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designations for sevasemten for the treatment of Becker muscular dystrophy (Becker) and for the treatment of Duchenne muscular dystrophy (Duchenne). Sevasemten is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage. Sevasemten is cu.

Edgewise Receives European Medicines Agency (EMA) Orphan Drug Designations for Sevasemten (EDG-5506) for the Treatment of Becker and Duchenne Muscular Dystrophies

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced positive two-year topline results from the ARCH trial. ARCH is an open label, single-center study assessing safety, tolerability, impact on muscle damage biomarkers, pharmacokinetics (PK) and functional measures with sevasemten (EDG-5506) in adults with Becker. Sevasemten is an orally administered small molecule designed to prevent contraction-induced.

Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker)

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the Company will present data on EDG-7500 at the American College of Cardiology's Annual Scientific Session (ACC.24). EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of diastolic dysfunc.

Edgewise Therapeutics Announces Upcoming Podium Presentation at the American College of Cardiology's 2024 Annual Scientific Session

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the Cantor Virtual Muscular Dystrophy Symposium on Tuesday, April 2, 2024, at 2:20 pm ET. The presentation will be webcast live; a link for the webcast can be found on the Edgewise events page and will be accessible for replay following the presentation. It is recommended that users connect to the webcast several minute.

Edgewise Therapeutics to Present at the Cantor Virtual Muscular Dystrophy Symposium on April 2, 2024

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the Leerink Partners Global Biopharma Conference on Monday, March 11, 2024, at 12:00 pm ET. The presentation will be webcast live; a link for the webcast can be found on the Edgewise events page and will be accessible for replay following the presentation. It is recommended that users connect to the webcast several minut.

Edgewise Therapeutics to Present at the Leerink Partners Global Biopharma Conference on March 11, 2024

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the company will present data on EDG-5506, an investigational therapy designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. The conference will take place at the Hilton Orlando in Orlando, FL from March 3-6, 2024. Details of the Edg.

Edgewise Therapeutics to Present on EDG-5506 for the Treatment of Becker Muscular Dystrophy at the 2024 MDA Clinical and Scientific Conference

The consensus price target hints at a 52.8% upside potential for Edgewise Therapeutics, Inc. (EWTX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Predict a 52.78% Upside in Edgewise Therapeutics, Inc. (EWTX): Here's What You Should Know

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the fourth quarter and full year of 2023 and recent business highlights. “In 2023, we made tremendous progress advancing our novel muscle-targeted therapeutics in the clinic,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “Most recently, we completed a successful financing enabling us to fully execute.

Edgewise Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne and Becker muscular dystrophy (Becker). The FDA previously gran.

Edgewise Receives U.S. FDA Fast Track Designation for EDG-5506 for the Treatment of Duchenne Muscular Dystrophy (Duchenne)

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The mean of analysts' price targets for Edgewise Therapeutics, Inc. (EWTX) points to a 33.3% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts See a 33.27% Upside in Edgewise Therapeutics, Inc. (EWTX): Can the Stock Really Move This High?

The mean of analysts' price targets for Edgewise Therapeutics, Inc. (EWTX) points to a 70.8% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Think Edgewise Therapeutics, Inc. (EWTX) Could Surge 70.76%: Read This Before Placing a Bet

Edgewise (EWTX) will issue secondary shares to raise $240 million in gross proceeds. The capital will be used to fund key initiatives, including the potential commercial launch of lead pipeline drugs.

Edgewise (EWTX) Rallies 35% on Issue of New Common Stock

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a leading muscle disease biopharmaceutical company, today announced the pricing of an underwritten offering of 21,818,182 shares of its common stock at an offering price of $11.00 per share. Edgewise anticipates gross proceeds from the offering to be approximately $240 million, before deducting underwriting discounts and commissions and offering expenses. The closing of the offering is expected to occur on January 23,.

Edgewise Therapeutics Announces Pricing of $240 Million Underwritten Offering of Common Stock

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BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, will present today at the 42nd Annual J.P. Morgan Healthcare Conference at 10:30 am PT (1:30 pm ET), and a live webcast will be available at www.edgewisetx.com. Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024. “In 2023, we had tremendous progress in the clinic advancing our novel oral t.

Edgewise Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

Edgewise Therapeutics, Inc. interim results from the phase 2 LYNX study, using EDG-5506 for the treatment of children ages 4 to 9 with DMD, are expected first half of 2024. Expansion opportunity exists to use EDG-5506 for the treatment of children and adolescent DMD patients ages 6 to 14 who have previously already been treated with gene therapy. It is expected that the global Duchenne Muscular Dystrophy treatment market size is expected to reach $3.89 billion by 2028.

Edgewise: DMD Data In The First Half Of 2024 Could Lead To Additional Testing

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the J.P. Morgan 42nd Annual Healthcare Conference on Tuesday, January 9, 2024, at 10:30 am PT (1:30 pm ET). The presentation will be webcast live; a link for the webcast can be found on the Edgewise events page and will be accessible for replay following the presentation. It is recommended that users connect to the webc.

Edgewise Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare Conference on January 9, 2024

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the launch of an educational website dedicated to the Becker muscular dystrophy (Becker) community: www.beckermusculardystrophy.com. This is the first website solely focused on providing Becker-specific resources to help individuals and caregivers better understand the disease, learn different approaches to care and stay up to date on advocacy partner.

Edgewise Therapeutics Launches First of Its Kind Educational Website Dedicated to the Becker Muscular Dystrophy Community

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has granted EDG-5506 Orphan Drug Designation (ODD) for the treatment of Duchenne muscular dystrophy (Duchenne) and Becker muscular dystrophy (Becker) and Rare Pediatric Disease Designation (RPDD) for the treatment of Duchenne. EDG-5506 is an investigational orally administered small molecule designed.

Edgewise Receives Orphan Drug and Rare Pediatric Disease Designations for Its Muscular Dystrophy Program from FDA

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BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2023 and recent business highlights. “I'm thrilled with the progress we've made in 2023 across our skeletal and cardiovascular programs,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “Most recently, we started enrolling individuals in two important studies: GRAND CANYON, a global p.

Edgewise Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, announced today that members of its senior management team will participate in the following upcoming investor conferences: Stifel 2023 Healthcare Conference Presentation: Wednesday, November 15, 2023, at 10:55 am ET Piper Sandler 35th Annual Healthcare Conference Presentation: Wednesday, November 29, 2023, at 8:00 am ET The presentations will be webcast live; links.

Edgewise Therapeutics to Present at Upcoming Investor Conferences

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the Company will present the results of nonclinical studies of EDG-7500 at the American Heart Association's (AHA) Scientific Sessions 2023 being held in Philadelphia from November 11 - 13. EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardia.

Edgewise to Present Data on EDG-7500 at the American Heart Association's Scientific Sessions 2023

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced an expansion of their clinical development program of EDG-5506, an investigational orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies, including Duchenne. The Company is initiating FOX, a new Phase 2 placebo-controlled trial in children and adolescent boys with Duchenne who have been previous.

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