BOULDER, Colo. , May 14, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc ., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 20, 2025 , at 9:00 am ET . The presentation will be webcast live; a link for the webcast can be found on the Edgewise Events & Presentations page and will be... Read More

Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) Strengthened balance sheet with net proceeds of approximately $188 million from the April 2025 public offering; pro-forma cash balance exceeds $624 million On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy (Duchenne) in the second quarter of 2025 Expect to... Read More

BOULDER, Colo. , April 2, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a leading muscle disease biopharmaceutical company, today announced the pricing of an underwritten offering of 9,935,419 shares of its common stock at an offering price of $20.13 per share. Edgewise anticipates gross proceeds from the offering to be approximately $200 million , before deducting underwriting discounts and commissions... Read More

Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM Four-week treatment with EDG-7500 demonstrated substantial improvements in measures of feel and function, reductions in key cardiac biomarkers and positive trends in measures of diastolic function EDG-7500 was generally well-tolerated; clinical activity was observed without meaningful... Read More

BOULDER, Colo. , March 26, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that members of the management team will hold a live webcast to discuss top-line data of EDG-7500 from the Phase 2 CIRRUS-HCM 28-day trial in patients with obstructive or nonobstructive HCM on Wednesday, April 2, 2025 , at 8:30 am ET . The team is excited to be... Read More

Company to host an Industry Forum to discuss the lived experience of Becker and clinical advancements featuring a leading neuromuscular disease expert and a patient advocate BOULDER, Colo. / Mar 11, 2025 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the company will present data on sevasemten, an investigational orally administered... Read More

BOULDER, Colo. / Mar 04, 2025 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the Leerink Partners Global Healthcare Conference on Tuesday, March 11, 2025, at 1:40 pm ET. The presentation will be webcast live; a link for the webcast can be found on the Edgewise Events & Presentations page and will be accessible... Read More

Completed enrollment of the GRAND CANYON global pivotal study of sevasemten in Becker muscular dystrophy (Becker) Announced positive top-line results from Phase 2 CANYON trial of sevasemten in Becker On track to report data from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) in the first quarter of 2025 On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular... Read More

Robert Blaustein, M.D., Ph.D. appointed as Chief Development Officer (CDO) Behrad Derakhshan, Ph.D. promoted to Chief Operating Officer (COO) BOULDER, Colo. / Jan 22, 2025 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced key changes to its executive team that will strengthen its leadership and sharpen the Company’s focus on late-stage clinical... Read More

Advancing robust clinical pipeline of novel therapeutics for serious muscular dystrophies and cardiac conditions Presenting at the 43 rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 1:30 p.m. PT (4:30 p.m. ET) BOULDER, Colo. / Jan 13, 2025 / Business Wire / Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided recent corporate updates and... Read More

Trial met primary endpoint of reduction in circulating levels of creatine kinase (CK), a biomarker associated with skeletal muscle damage, in the largest Becker interventional trial to date On the key secondary endpoint, sevasemten-treated patients showed stabilization of North Star Ambulatory Assessment (NSAA) with a trend towards improvement at 12 months compared to placebo Sevasemten was well-tolerated and no new safety... Read More

BOULDER, Colo. / Dec 05, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today provided information regarding the company’s relationship with Dr. Han Phan at Rare Disease Research. On November 27, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Dr. Phan based on a 2024 site inspection related to her work with another... Read More

BOULDER, Colo. / Nov 26, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024, at 1 pm ET. The presentation will be webcast live; a link for the webcast can be found on the Edgewise Events & Presentations page and will be... Read More

On track to announce top-line results from Phase 2 CANYON trial of sevasemten in adults with Becker in December 2024 Advanced Phase 2 LYNX and FOX trials of sevasemten in children and adolescents with Duchenne Advanced Phase 2 CIRRUS-HCM trial of EDG-7500 in patients with obstructive and non-obstructive Hypertrophic Cardiomyopathy (HCM) Announced positive top-line data from Phase 1 trial in healthy subjects and Phase 2... Read More

BOULDER, Colo. / Oct 01, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced its participation at the 29th International Annual Congress of the World Muscle Society (WMS) with an industry-sponsored symposium and the presentation of seven scientific posters. These presentations will highlight the effects of sevasemten in individuals with... Read More

In a Phase 1 in healthy subjects, EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF) CIRRUS-HCM single-dose trial of EDG-7500 in obstructive HCM demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without meaningful changes in LVEF Company announced... Read More

BOULDER, Colo. / Sep 17, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that members of the management team will hold a live webcast to discuss top-line data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM on Thursday, September 19, 2024, at... Read More

Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers; Dosing patients in Phase 2 CIRRUS-HCM trial of EDG-7500 in individuals with oHCM Continued to advance GRAND CANYON global pivotal cohort of sevasemten in adults with Becker Advanced Phase 2 LYNX and FOX trials of sevasemten in children with Duchenne BOULDER, Colo. / Aug 08, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading... Read More

BOULDER, Colo. / May 10, 2024 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the RBC Capital Markets Global Healthcare Conference on Wednesday, May 15, 2024, at 3:35 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... Read More

Announced positive two-year topline results of sevasemten ARCH open label trial and advanced GRAND CANYON pivotal cohort in Becker Positive interim topline data for DUNE trial of sevasemten in Becker Expanded Phase 2 LYNX trial of sevasemten in Duchenne Anticipated to overenroll Phase 2 FOX trial in Duchenne boys previously treated with gene therapy Initiated Phase 2 CIRRUS-HCM trial of EDG-7500 in patients with obstructive... Read More

BOULDER, Colo. / May 07, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the appointment of biotechnology industry veteran Arlene Morris to its Board of Directors. Ms. Morris has extensive experience in the pharmaceutical and biotechnology industries serving in numerous executive management and board roles. “With over 30 years of... Read More

BOULDER, Colo. / May 06, 2024 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the dosing of the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and... Read More

BOULDER, Colo. / Apr 23, 2024 / 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... Read More

The North Star Ambulatory Assessment (NSAA) remained stable relative to declines reported in Becker natural history studies Significant decreases were observed in circulating levels of creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), biomarkers associated with skeletal muscle damage Sevasemten was... Read More

Presentation highlights beneficial effects of chronic EDG-7500 treatment in preventing diastolic dysfunction in an animal model of non-obstructive hypertrophic cardiomyopathy (HCM) BOULDER, Colo. / Mar 28, 2024 / 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... Read More

BOULDER, Colo. / Mar 27, 2024 / 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... Read More

BOULDER, Colo. / Mar 05, 2024 / 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... Read More

Company to host an Industry Forum to discuss its approach to protecting and preserving dystrophic muscle featuring key opinion leaders BOULDER, Colo. / Feb 28, 2024 / 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... Read More

Overenrolled CANYON and advanced the global pivotal cohort, GRAND CANYON, of EDG-5506 in Becker muscular dystrophy (Becker) Advanced Phase 2 LYNX trial of EDG-5506 including new cohort for boys with Duchenne muscular dystrophy (Duchenne) not currently treated with corticosteroids Initiating Phase 2 FOX trial in boys with Duchenne who have been previously treated with gene therapy Advanced Phase 1 trial of EDG-7500, a novel... Read More

BOULDER, Colo. / Feb 13, 2024 / 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... Read More

BOULDER, Colo. / Jan 19, 2024 / 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... Read More

BOULDER, Colo. / Jan 09, 2024 / 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... Read More

BOULDER, Colo. / Dec 19, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that management will present at the J.P. Morgan 42 nd 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... Read More

Becker is a serious neuromuscular condition with no approved therapies BOULDER, Colo. / Dec 18, 2023 / 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... Read More

BOULDER, Colo. / Nov 30, 2023 / 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... Read More

Fully enrolled CANYON and now enrolling the global pivotal cohort, GRAND CANYON, of EDG-5506 in Becker muscular dystrophy (Becker) Expanding Phase 2 LYNX trial of EDG-5506 including new cohort for boys with Duchenne not currently treated with corticosteroids Initiated new Phase 2 FOX trial in boys with Duchenne muscular dystrophy (Duchenne) who have been previously treated with gene therapy Advancing Phase 1 trial of... Read More

BOULDER, Colo. / Nov 08, 2023 / 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 35 th Annual Healthcare Conference Presentation:... Read More

BOULDER, Colo. / Nov 01, 2023 / 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... Read More

Initiating new Phase 2 FOX trial in boys with Duchenne who have been previously treated with gene therapy Continuing dose escalation of Phase 2 LYNX trial and initiating a cohort in boys with Duchenne not currently treated with corticosteroids BOULDER, Colo. / Oct 26, 2023 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced an expansion of their... Read More

Company to host conference symposium to discuss its approach to protecting dystrophic muscle featuring key opinion leaders and 12-month results from the ARCH open label study of EDG-5506 in adults with Becker BOULDER, Colo. / Sep 27, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced that the Company will present on EDG-5506, an orally... Read More

GRAND CANYON is the first pivotal study of an investigational therapy for Becker CANYON, the initial Phase 2 cohorts, is fully enrolled BOULDER, Colo. / Sep 26, 2023 / Business Wire / Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the start of enrollment of GRAND CANYON, a global pivotal study of EDG-5506 in individuals with Becker. GRAND CANYON is an expansion... Read More

EDG-7500 is a first-in-class oral, selective, cardiac sarcomere modulator that has the potential to benefit a broad spectrum of HCM and other cardiomyopathy patients BOULDER, Colo. / Sep 14, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced initial dosing in a Phase 1 trial of EDG-7500. EDG-7500 is a first-in-class oral, selective, cardiac... Read More

Announced positive 12-month topline results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (Becker) Advancing Phase 2 trial of EDG-5506 in Becker muscular dystrophy (Becker, CANYON), which now includes a pivotal cohort called GRAND CANYON Advancing Phase 2 trial of EDG-5506 in Duchenne muscular dystrophy (Duchenne, LYNX) Advancing EDG-7500, a novel sarcomere modulator for hypertrophic... Read More

Sustained positive trend in North Star Ambulatory Assessment (NSAA) scores relative to BMD natural history Significant decreases in levels of serum creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), enzyme biomarkers associated with skeletal muscle damage EDG-5506 was well-tolerated at all doses Company... Read More

BOULDER, Colo. / Jun 06, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, announced today that management will present at the Goldman Sachs Global Healthcare Conference on Tuesday, June 13, 2023, at 10 am PT (1 pm ET). The presentation... Read More

Advancing Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON) and Duchenne muscular dystrophy (DMD, LYNX) Advancing exercise challenge study of EDG-5506 in Limb girdle muscular dystrophy 2I, BMD and McArdle Disease (LGMD2I/R9, BMD, McArdle, DUNE) Advancing IND-enabling studies of EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy (HCM); Phase 1 start expected in 2H2023 Cash, cash... Read More

BOULDER, Colo. / May 02, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, announced today that management will participate in fireside chats at two upcoming investor conferences: BofA Securities 2022 Healthcare Conference Presentation:... Read More

Data provide key insights supporting Edgewise’s strategy to advance EDG-5506 for the treatment of Duchenne and Becker muscular dystrophy BOULDER, Colo. / Mar 30, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced the... Read More

BOULDER, Colo. / Mar 21, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that management will present at the virtual Stifel 2023 CNS Days on Tuesday, March 28, 2023, at 2 pm ET. The presentation will be webcast live; a... Read More

BOULDER, Colo. / Mar 14, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (Nasdaq: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that the company will present on EDG-5506, an investigational therapy designed to protect injury-susceptible fast skeletal muscle fibers in... Read More

BOULDER, Colo. / Mar 06, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for individuals with devastating muscle disorders, announced today the appointment of Jonathan C. Fox, M.D., Ph.D., FACC, to its Board of Directors. Dr. Fox brings considerable expertise in clinical development... Read More

BOULDER, Colo. / Mar 01, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that management will present at the Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023, at 9:10 am ET. The presentation will be... Read More

BOULDER, Colo. / Feb 28, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that the company will present on EDG-7500, an investigational therapy designed to normalize excess cardiac contraction (systolic) and deficient... Read More

BOULDER, Colo. / Feb 23, 2023 / Business Wire / Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today reported financial results for the fourth quarter and full year of 2022 and recent business highlights. “In 2022, we made significant progress advancing our... Read More

BOULDER, Colo. / Feb 07, 2023 / Business Wire / Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that management will present at the virtual SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023, at 1:00 pm ET. The... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today announced that management will present at the J.P. Morgan 41 st Annual Healthcare Conference on Tuesday, January 10, 2023, at 9:45 am PT (12:45 pm ET). The presentation will be webcast live; a link for... Read More

Webcast event to feature preclinical data of its lead hypertrophic cardiomyopathy (HCM) candidate and commentary by a renowned cardiologist Management to provide 2023 Company outlook at the 41 st Annual J.P. Morgan Healthcare Conference on January 10, 2023 Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for... Read More

Former Chief Medical Officer of MyoKardia and Renovacor to lead cardiovascular development at Edgewise BOULDER, Colo.--( BUSINESS WIRE )-- Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for individuals with devastating muscle disorders, announced today the appointment of Marc Semigran, M.D., as Chief... Read More

Rare Disease Research, LLC first site activated to enroll children with DMD Edgewise to hold virtual webinars with the patient community to discuss EDG-5506 clinical trials in November Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced that it has initiated the... Read More

Continued positive trend in North Star Ambulatory Assessment (NSAA) scores relative to BMD natural history trajectories Highly significant decreases in levels of serum creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), enzyme biomarkers strongly associated with muscle damage observed in BMD EDG-5506 continues to... Read More

Company to host conference symposium to discuss its approach to protecting dystrophic muscle featuring key opinion leaders and 6-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with BMD Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX) today announced the closing of its upsized underwritten public offering of 13,372,093 shares of its common stock at a price to the public of $10.32 per share, which includes the exercise in full by the underwriters of their option to purchase additional shares. The total gross proceeds from the offering, before deducting underwriters’ discounts and commissions and offering expenses,... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX) today announced the pricing of its upsized underwritten public offering of 11,627,907 shares of its common stock at a price to the public of $10.32 per share. All of the shares are to be sold by Edgewise Therapeutics. In addition, Edgewise Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,744,186 shares of its common stock. Before deducting... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering of $100 million of its common stock. In addition, Edgewise Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $15.0 million of its common stock at the public offering price, less underwriting discounts and commissions. All of... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today positive 4-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics (PK) of EDG-5506 in... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced that the U.S. Food and Drug Administration (FDA) has authorized a clinical trial of EDG-5506 in children with DMD. The Company expects to begin dosing participants in the LYNX Phase 2 trial in the fourth quarter... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today reported financial results for the second quarter of 2022 and recent business highlights. “Edgewise has made significant progress in the first half of the year most notably with the continued positive EDG-5506 clinical... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in a panel discussion and one-on-one investor meetings at the virtual 2022 Wedbush PacGrow Healthcare Conference on August 9 and 10. The “Muscle Beach”... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced the initiation of the CANYON Phase 2 clinical trial evaluating EDG-5506 in individuals with BMD. EDG-5506 is an orally administered small molecule myosin modulator designed to protect injury-susceptible fast... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today positive 2-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics (PK) of EDG-5506 in... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that new 2-month interim data from the ARCH open label study of EDG-5506 in individuals with BMD will be presented at the 2022 New Directions in Biology and Disease of Skeletal Muscle Conference , being held June 20-23, 2022.... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in the following upcoming investor conferences: Jefferies Healthcare Conference Presentation: Friday, June 10, 2022, at 10 am ET Goldman Sachs Annual... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today reported financial results for the first quarter of 2022 and recent business highlights. “2022 is off to a great start with the positive EDG-5506 data in individuals with BMD, a disorder for which there are no approved... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in fireside discussions and one-on-one investor meetings at two upcoming investor conferences: BofA Securities 2022 Healthcare Conference Fireside... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced the initiation of an Edgewise-funded observational trial in individuals with BMD. The trial is designed to understand the disease progression of individuals with BMD as assessed by functional measures and imaging... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced that the company will present on EDG-5506, an investigational therapy designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, at the Muscular Dystrophy Association (MDA) Annual... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today reported financial results for the fourth quarter and full year of 2021 and recent business highlights. “2021 was a tremendous year for Edgewise starting with our successful initial public offering that provided financial... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today positive topline results from the BMD, or Phase 1b, portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, PK and pharmacodynamics (PD) of EDG-5506, an orally administered small... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today announced plans to report topline results from the Phase 1b clinical trial of EDG-5506 in individuals with BMD on January 5, 2022, at 9:00 am ET. The webcast event will feature a presentation of the results which support... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in a fireside chat and one-on-one investor meetings at the virtual Evercore ISI 4 th Annual HEALTHCONx conference on December 2. The fireside chat will... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today reported financial results for the third quarter 2021 and recent business highlights. “We achieved a significant milestone with our positive topline results from the EDG-5506 Phase 1 MAD study, which support advancing the... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today positive topline results from the MAD portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, PK and PD of escalating doses of EDG-5506, an orally administered small molecule myosin... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, announced today that members of its senior management team will participate in the SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1×1 Event, on September 23, 2021. During the event, members of the... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDG-5506 for the treatment of individuals with BMD. EDG-5506, a selective, small molecule myosin inhibitor designed to protect... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today reported financial results for the second quarter 2021 and recent business highlights. “We continue to make excellent progress on our pipeline of novel therapeutics for severe, rare muscle disorders,” said Kevin Koch, Ph.D., President and... Read More

Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, announced today that members of its management team will participate in a fireside chat and one-on-one investor meetings at the virtual Wedbush PacGrow Healthcare Conference on Wednesday, August 11. The fireside chat will be webcast live at 3:30... Read More

Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that the company will present at the 2021 PPMD Annual Conference and the 2021 New Directions in Biology and Disease of Skeletal Muscle Conference . 2021 PPMD Annual Conference Presentation: An Introduction to Edgewise Therapeutics... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced that members of its management team will participate in a fireside chat and one-on-one investor meetings at the virtual Goldman Sachs 42 nd Annual Global Healthcare Conference on Wednesday, June 9, 2021 at 5:30 p.m. ET. The... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today reported financial results for the first quarter 2021 and recent business highlights. “Our successful IPO was transformative for Edgewise, providing the financial stability to advance a meaningful pipeline of novel therapeutics for... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced the publication of the first cross-sectional, retrospective study to describe selective elevation of fast but not slow skeletal muscle fiber injury biomarkers in the blood of patients with Becker and Duchenne muscular dystrophy... Read More

Edgewise Therapeutics, Inc. , (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced the appointment of Joanne M. Donovan, M.D., Ph.D., to the position of Chief Medical Officer. Dr. Donovan will be responsible for leading clinical, medical and regulatory strategy and operations for the company’s pipeline,... Read More