4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

3 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

- Robert Blaustein, M.D., Ph.D. appointed as Chief Development Officer (CDO) - - Behrad Derakhshan, Ph.D. promoted to Chief Operating Officer (COO) - 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 development. These changes include the addition of Robert Blaustein, M.D., Ph.D., joining the Company as Chief Development Officer and the promotion of Behrad Derakhshan, Ph.D. from Chief Business Officer to Chief Operating Officer. This press release features multimedia. View the full release here: https:

- Advancing robust clinical pipeline of novel therapeutics for serious muscular dystrophies and cardiac conditions - - Presenting at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 1:30 p.m. PT (4:30 p.m. ET) - Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today provided recent corporate updates and highlighted upcoming priorities for 2025. Edgewise Chief Executive Officer, Kevin Koch, Ph.D., will present these updates today at the Annual J.P. Morgan Healthcare Conference. "We were pleased with our progress in 2024 as we advanced our drug pipeline and have great momentum heading into 2025. With positive

Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today announced that Kevin Koch, Ph.D, President and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 1:30 pm PT (4:30 pm ET). The discussion will include updates on its cardiovascular and muscular dystrophy programs and 2025 key milestones. The presentation will be webcast live; a link for the webcast can be found on the Edgewise Events & Presentations page and will be accessible for replay, for a limited time, following the conference. It is recommended that users connect to the live webcast several minutes prior to the

– 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 concerns were observed – – Edgewise leadership to discuss CANYON findings on Monday, December 16 at 8:30 a.m. Eastern Time at a virtual investor event – Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today

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 company. This warning letter is unrelated to any Edgewise clinical trial or data. None of the Edgewise clinical trials are the subject of the FDA's warning letter. Edgewise has audited Dr. Phan's site multiple times and believes that the data related to the Edgewise clinical trials at the site are being acquired and stored

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 accessible for replay, for a limited time, following the conference. It is recommended that users connect to the live webcast several minutes prior to the start to ensure a timely connection. About Edgewise Therapeutics Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutic

– 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 CIRRUS-HCM trial in patients with obstructive HCM – Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the third quarter of 2024 and recent business highlights. "We continue t

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 Becker based on findings from the DUNE and ARCH clinical trials, as well as provide perspectives on biomarker and functional endpoints being studied in the CANYON Phase 2 trial. Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in muscular dystrophies including Becker

– 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 dosing of first patients in CIRRUS-HCM 28-day trial – – Edgewise to host webcast event on Thursday, September 19 at 8:30 a.m. Eastern Time – Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today announced top-line data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 C

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 8:30 am ET. The team will be joined by CIRRUS-HCM investigator, Anjali T. Owens, M.D., Medical Director, Center for Inherited Cardiac Disease, Associate Professor of Medicine, University of Pennsylvania, who will share her perspective of EDG-7500 and HCM. An accompanying slide presentation will also be available. To reg

– Remarkable North Star Ambulatory Assessment scale (NSAA) improvements relative to BMD natural history trajectories – – Significant decrease in levels of serum creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), enzyme biomarkers strongly associated with muscle damage caused by BMD – – EDG-5506 continues to be well-tolerated with no serious adverse events observed – – Management hosting webcast to discuss findings on September 12 at 8:30 a.m. Eastern Time – 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 pos

– EDG-5506 treatment significantly lowered muscle damage biomarkers in adults with BMD – – BMD patients were more active during 2 months of dosing with EDG-5506 relative to activity measured in BMD patients in the Phase 1 study – – EDG-5506 was well tolerated with no serious adverse events observed; safety profile supported dose escalation to 15 mg daily for all patients – – Management hosting webcast to discuss findings on June 21 at 9:00 a.m. Eastern Time – 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

- Edgewise management to host webcast conference call on Tuesday, June 21, 2022 at 9 a.m. Eastern Time - - Additional presentations and posters featuring EDG-5506 to be featured at the New Directions Conference and the upcoming PPMD Annual Conference - 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. Edgewise ARCH Interi

– EDG-5506 was well tolerated with no serious adverse events observed – – Pharmacokinetic (PK) data demonstrated robust target engagement with achievement of muscle concentrations beyond levels predicted to provide meaningful clinical benefit – – EDG-5506 treatment resulted in significant lowering of muscle damage biomarkers in adults with BMD after only two weeks of dosing – – Management hosting webcast to discuss findings today at 9:00 a.m. Eastern Time – 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 r

– Webcast event to feature EDG-5506 topline results presentation and commentary by a leading neuromuscular disease expert – – Management to provide 2022 Company outlook at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022 – 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 advancement of the program,

– EDG-5506 was generally well tolerated with no serious adverse events observed to date – – Pharmacokinetic (PK) data demonstrated robust target engagement with achievement of muscle concentrations well above efficacious levels observed in preclinical disease models – – Pharmacodynamic (PD) data demonstrated dose proportionate effect on involuntary twitch inhibition in HVs – – Phase 1a single ascending dose/MAD package supports initiation of Phase 2 trials in BMD and Duchenne muscular dystrophy (DMD) in 2022 – – Management hosting webcast to discuss findings today at 9:00 a.m. Eastern Time – Edgewise Therapeutics, Inc. (NASDAQ:EWTX), a clinical-stage biopharmaceutical company focused o

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)

4 - Edgewise Therapeutics, Inc. (0001710072) (Issuer)