Edgewise Therapeutics, Inc. Stock Price, News & Analysis

Edgewise Therapeutics, Inc. (EWTX) has initiated the CANYON Phase 2 clinical trial for EDG-5506, targeting Becker Muscular Dystrophy (BMD). This trial will observe 66 individuals over 12 months to assess safety, pharmacokinetics, biomarkers, and functional measures. There are no approved treatments for BMD, highlighting the unmet medical need. EDG-5506 is designed to protect muscle fibers in dystrophinopathies like BMD and Duchenne muscular dystrophy, following positive Phase 1 results. This trial marks a critical step in potential therapy development for individuals with BMD.

Edgewise Therapeutics announced positive interim results from the ARCH study, evaluating EDG-5506 for Becker Muscular Dystrophy (BMD). After two months of treatment, key muscle damage biomarkers creatine kinase and fast skeletal muscle troponin I decreased by 30% and 68%, respectively. BMD patients showed increased physical activity compared to earlier study levels. EDG-5506 was well-tolerated; patients escalated to 15 mg daily without serious adverse effects. A conference call is scheduled for June 21 to discuss these findings further.

Edgewise Therapeutics (NASDAQ: EWTX) is set to present new interim data from the ARCH study on EDG-5506, targeting Becker Muscular Dystrophy (BMD), at the 2022 New Directions Conference from June 20-23, 2022. A conference call discussing this data will occur on June 21 at 9 a.m. ET. Additionally, further presentations will be showcased at the 2022 PPMD Annual Conference on June 23-26. EDG-5506 has received Fast Track designation from the FDA, emphasizing its potential in treating severe neuromuscular disorders.

Edgewise Therapeutics, Inc. (NASDAQ: EWTX) announced that its senior management will participate in two upcoming investor conferences:

• Jefferies Healthcare Conference: Presentation on June 10, 2022, at 10 am ET.
• Goldman Sachs Annual Global Healthcare Conference: Fireside chat on June 15, 2022, at 4 pm PT (7 pm ET).

Both events will be webcast live and available for replay. Edgewise focuses on developing therapies for rare muscle disorders using a proprietary drug discovery platform.

Edgewise Therapeutics (EWTX) announced significant progress, having completed enrollment in the ARCH study for EDG-5506 targeting Becker muscular dystrophy (BMD). A Natural History Trial for BMD has commenced, aiming to recruit around 150 participants. The company reported a net loss of $14.7 million or $0.30 per share for Q1 2022, with cash reserves of $265.8 million expected to sustain operations through 2024. Phase 2 trials for BMD and Duchenne muscular dystrophy (DMD) are planned for 2022, with interim data from the ARCH study anticipated in Q2 2022.

Edgewise Therapeutics (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, will participate in two upcoming investor conferences. The BofA Securities 2022 Healthcare Conference fireside chat is scheduled for May 10, 2022, at 8:40 am PT. The RBC Capital Markets Global Healthcare Conference fireside chat will occur on May 18, 2022, at 3:35 pm ET. Presentations will be webcast live and available for replay on Edgewise’s events page.

Edgewise Therapeutics (NASDAQ: EWTX) has launched a funded observational trial to study Becker Muscular Dystrophy (BMD) progression. Led by the GRASP consortium and Virginia Commonwealth University, the two-year study aims to recruit around 150 participants aged 8 and older across the U.S. and Europe. The trial will collect data to enhance understanding of BMD, which currently has no approved therapies in the U.S. Edgewise's lead candidate, EDG-5506, has received Fast Track designation and is anticipated to enter Phase 2 trials for BMD in 2022.

Edgewise Therapeutics (NASDAQ: EWTX) announced its participation in the Muscular Dystrophy Association Annual Conference from March 13-16, 2022, in Nashville, TN. The company will present its investigational therapy EDG-5506, aimed at protecting skeletal muscle fibers in dystrophinopathies. Key presentations include a platform session led by Alan Russell and a podium presentation by Joanne Donovan. Additionally, Edgewise will host a symposium on March 14, featuring expert Luca Bello.

Edgewise Therapeutics (EWTX) announced positive topline results from the EDG-5506 Phase 1b clinical trial for Becker muscular dystrophy (BMD). The trial demonstrated safety and significant reductions in muscle damage biomarkers, including 71% reduction in creatine kinase and 83% in troponin levels. The company plans to initiate Phase 2 trials in BMD and Duchenne muscular dystrophy (DMD) in 2022. As of December 31, 2021, Edgewise had $281 million in cash and equivalents. For 2021, R&D expenses totaled $32.2 million, contributing to a net loss of $42.8 million.