Edgewise Therapeutics, Inc. - EWTX STOCK NEWS

Edgewise Therapeutics (NASDAQ: EWTX) intends to offer and sell $100 million of its common stock in an underwritten public offering. An additional 30-day option for underwriters to purchase up to $15 million of common stock is also included. The offering is subject to market conditions and no assurance can be given regarding its completion or terms. J.P. Morgan and SVB Securities are acting as joint book-running managers. Edgewise focuses on innovative treatments for rare neuromuscular and cardiac disorders, indicating potential growth opportunities with the capital raised.

Edgewise Therapeutics (NASDAQ: EWTX) announced positive interim results from its ARCH study, focusing on the investigational drug EDG-5506 for Becker muscular dystrophy (BMD). After four months, participants exhibited an average 1.17-point increase in the North Star Ambulatory Assessment (NSAA) and significant reductions in muscle damage biomarkers: serum creatine kinase levels decreased by 29% and fast skeletal muscle troponin I by 74%. EDG-5506 was well-tolerated, with no serious adverse events. A webcast discussing the findings is scheduled for September 12 at 8:30 a.m. ET.

Edgewise Therapeutics (NASDAQ: EWTX) announced FDA authorization for the LYNX Phase 2 clinical trial of EDG-5506 in children with Duchenne Muscular Dystrophy (DMD). The trial aims to enroll approximately 27 participants, aged 4 to 9, across the U.S. to assess safety and efficacy over 12 weeks. EDG-5506, previously successful in BMD trials, is designed to mitigate muscle damage. Positive feedback from patient advocacy groups underscores the significance of expanding treatment options for DMD patients, a condition affecting 12,000-15,000 in the U.S.

Edgewise Therapeutics announced positive interim results for its EDG-5506 treatment in Becker muscular dystrophy (BMD) from the ARCH study. The ongoing trial indicates a significant reduction in muscle damage biomarkers, with creatine kinase and troponin I decreasing by 30% and 68%, respectively, after two months. The company has initiated Phase 2 trials for both BMD and plans for Duchenne muscular dystrophy (DMD) later in 2022. Financially, as of June 30, 2022, Edgewise reported $248.4 million in cash, expected to sustain operations through 2024.

Edgewise Therapeutics (NASDAQ: EWTX) has announced that its senior management will participate in the virtual 2022 Wedbush PacGrow Healthcare Conference on August 9-10. The company is focused on developing therapies for rare muscle disorders. A live panel discussion titled “Muscle Beach” is scheduled for August 9 at 2:20 pm ET and will be available for replay. Edgewise employs a unique drug discovery platform aimed at treating severe neuromuscular and cardiac disorders.

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.