Edgewise Therapeutics, Inc., a biopharmaceutical company, develops small molecule therapies for musculoskeletal diseases. It offers a precision medicine muscle platform that generates programs to address various muscle disorders, such as Duchenne, Becker, and limb girdle muscular dystrophies. The company develops a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address genetically defined muscle disorders. Edgewise Therapeutics, Inc. was founded in 2017 and is headquartered in Boulder, Colorado.
IPO Year: 2021
Exchange: NASDAQ
Website: edgewisetx.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/7/2024 | $48.00 | Overweight | Piper Sandler |
| 5/1/2023 | Buy | Truist | |
| 8/25/2022 | $5.00 | Neutral → Sell | Goldman |
| 4/13/2022 | $31.00 | Outperform | RBC Capital Mkts |
| 2/14/2022 | $33.00 → $32.00 | Overweight | JP Morgan |
| 1/28/2022 | $11.00 | Neutral | Goldman |
| 1/6/2022 | $30.00 → $33.00 | Overweight | JP Morgan |
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10-Q - Edgewise Therapeutics, Inc. (0001710072) (Filer)
8-K - Edgewise Therapeutics, Inc. (0001710072) (Filer)
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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)
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)
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 exceptional leadership experience in the biotech industry, we are delighted to welcome Arlene to our Board," said Kevin Koch, Ph.D., President and Chief Executive Officer. "Arlene brings invaluable expertise in strategic development and operational excellence, and we are thankful to count her as a valued advisor as we contin
– President and Chief Medical Officer (CMO) of BridgeBio Pharma and Former CMO of MyoKardia brings strong cardiovascular expertise to Edgewise – 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 and regulatory strategy to Edgewise, serving currently as President and CMO at BridgeBio Pharma, and previously as CMO at MyoKardia, where he was one of the inventors of Camzyos
– Former Chief Medical Officer of MyoKardia and Renovacor to lead cardiovascular development at Edgewise – 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 Development Officer. Dr. Semigran brings considerable clinical development and translational medicine experience to Edgewise, having most recently served as Chief Medical Officer (CMO) at Renovacor through its acquisition by Rocket Pharmaceuticals, Inc., and previously served as CMO and Senior Vice President o
– Rare disease expert joins as company continues to advance lead muscular dystrophy product candidate in clinical development – 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, including EDG-5506, the company's lead product candidate that is advancing in clinical development for Duchenne and Becker muscular dystrophy (DMD and
– 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
– 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 – Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the second quarter of 2024 and recent business highlights. "We continue to make strong progress on our cardiac and skeletal muscle programs," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. "We look
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 following the presentation. It is recommended that users connect to the 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 therapeutics for muscular dystrophies and serious
– 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 HCM – Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2024 and recent business highlights. "2024 is off to a great start with tremendou
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 exceptional leadership experience in the biotech industry, we are delighted to welcome Arlene to our Board," said Kevin Koch, Ph.D., President and Chief Executive Officer. "Arlene brings invaluable expertise in strategic development and operational excellence, and we are thankful to count her as a valued advisor as we contin
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 other diseases of diastolic dysfunction. The Phase 2 trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of EDG-7500 in patients with obstructive HCM. Part A of the trial will evaluate single doses and Part B will evaluate multiple oral doses of EDG-7500 over 28 days. "Based on the str
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 currently in late-stage clinical trials for individuals with Becker and is also being studied in Duchenne. "Receiving Orphan Drug designation in the U.S. and now in Europe highlights alignment across regions on the urgent and critical
Piper Sandler initiated coverage of Edgewise Therapeutics with a rating of Overweight and set a new price target of $48.00
Truist initiated coverage of Edgewise Therapeutics with a rating of Buy
Goldman downgraded Edgewise Therapeutics from Neutral to Sell and set a new price target of $5.00
RBC Capital Mkts initiated coverage of Edgewise Therapeutics with a rating of Outperform and set a new price target of $31.00
JP Morgan reiterated coverage of Edgewise Therapeutics with a rating of Overweight and set a new price target of $32.00 from $33.00 previously
Goldman initiated coverage of Edgewise Therapeutics with a rating of Neutral and set a new price target of $11.00
JP Morgan reiterated coverage of Edgewise Therapeutics with a rating of Overweight and set a new price target of $33.00 from $30.00 previously
SVB Leerink initiated coverage of Edgewise Therapeutics with a rating of Outperform and set a new price target of $34.00
Wedbush initiated coverage of Edgewise Therapeutics with a rating of Outperform and set a new price target of $38.00
JP Morgan initiated coverage of Edgewise Therapeutics with a rating of Overweight and set a new price target of $34.00
RBC Capital analyst Leonid Timashev reiterates Edgewise Therapeutics (NASDAQ:EWTX) with a Outperform and maintains $32 price target.
JP Morgan analyst Tessa Romero maintains Edgewise Therapeutics (NASDAQ:EWTX) with a Overweight and raises the price target from $27 to $30.
Piper Sandler analyst Yasmeen Rahimi maintains Edgewise Therapeutics (NASDAQ:EWTX) with a Overweight and maintains $48 price target.
Wedbush analyst Laura Chico reiterates Edgewise Therapeutics (NASDAQ:EWTX) with a Outperform and maintains $31 price target.
- SEC Filing
Edgewise Therapeutics (NASDAQ:EWTX) reported quarterly losses of $(0.33) per share which beat the analyst consensus estimate of $(0.39) by 15.38 percent. This is a 8.33 percent increase over losses of $(0.36) per share from the same period last year.
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Edgewise Therapeutics, Inc., (NASDAQ:EWTX), a leading muscle disease biopharmaceutical company, today announced the dosing of the first patient in the Phase 2 CIRRUS-HCMtrial 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 other diseases of diastolic dysfunction. The Phase 2 trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of EDG-7500 in patients with obstructive HCM. Part A of the trial will evaluate single doses and Part B will evaluate multiple oral doses of EDG-7500 over 28 days."Based on the strength
– 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