Edgewise Therapeutics, Inc. - EWTX STOCK NEWS

Edgewise Therapeutics (NASDAQ: EWTX) plans to announce topline results from the Phase 1b clinical trial of EDG-5506 for Becker muscular dystrophy (BMD) on January 5, 2022. The event will feature expert commentary and details about the new open-label study ARCH. The trial has enrolled 7 participants and assessed a 20 mg dose for 14 days, focusing on safety and biomarkers for muscle damage. A follow-up Phase 2 clinical trial is anticipated to begin in the first half of 2022 for BMD and later in the year for Duchenne muscular dystrophy (DMD).

Edgewise Therapeutics (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, has announced its participation in the 4th Annual HEALTHCONx conference hosted by Evercore ISI on December 2. Senior management will engage in a fireside chat and one-on-one investor meetings. The webcast of the fireside chat will begin at 1 PM ET and will be available for replay. Edgewise Therapeutics focuses on developing small molecule therapies for rare muscle disorders, employing a holistic approach to drug discovery aimed at addressing significant unmet medical needs.

Edgewise Therapeutics (EWTX) announced positive topline results from its EDG-5506 Phase 1 MAD study, showing safety and tolerability in healthy volunteers and initiating dosing in Becker muscular dystrophy (BMD) patients. Phase 2 trials for BMD and Duchenne muscular dystrophy (DMD) are expected to start in 2022. Financially, the company reported $290 million in cash and marketable securities as of September 30, 2021, with a net loss of $12.9 million for Q3 2021. R&D expenses rose significantly, indicating ongoing investments in clinical trials and company growth.

Edgewise Therapeutics (NASDAQ: EWTX) announced positive topline results from the Phase 1 clinical trial of EDG-5506, aimed at treating Becker muscular dystrophy (BMD) and Duchenne muscular dystrophy (DMD). EDG-5506 was well tolerated, showing no serious adverse events. Pharmacokinetic data indicated high target engagement, with muscle concentrations surpassing efficacious levels from preclinical models. The results support the initiation of Phase 2 trials in 2022. Management is optimistic about EDG-5506’s potential to minimize muscle damage in these disorders.

Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, announced participation in the SVB Leerink CybeRx Series: Neuromuscular, Rare Diseases & Genetic Medicines 1×1 Event on September 23, 2021. The senior management team will engage in one-on-one investor meetings during this event. Edgewise focuses on developing innovative, orally bioavailable therapies for rare muscle disorders. The company employs an advanced drug discovery platform aimed at addressing significant unmet medical needs in muscle biology.

Edgewise Therapeutics (NASDAQ: EWTX) announced the FDA has granted Fast Track designation for EDG-5506, aimed at treating Becker muscular dystrophy (BMD). This selective myosin inhibitor is currently in a Phase 1 clinical trial, with topline data expected later in 2021. The Fast Track designation emphasizes the urgent need for therapies addressing serious conditions like BMD, which affects roughly 4,000-5,000 individuals in the U.S. EDG-5506 seeks to offer a novel therapeutic option, targeting the underlying issues caused by dysfunctional dystrophin in muscle tissue.

Edgewise Therapeutics (NASDAQ: EWTX) reported its Q2 2021 financial results, highlighting ongoing clinical progress with EDG-5506, its lead candidate for treating Duchenne and Becker muscular dystrophies. Cash and equivalents stood at $299 million. R&D expenses surged to $7.9 million, primarily due to clinical trial advancements. Net loss reached $10.4 million ($0.21 per share), up from $4.0 million year-over-year. The company anticipates topline data from its Phase 1 trials by the end of 2021, focusing on establishing a new standard of care for severe muscle disorders.

Edgewise Therapeutics (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, will participate in the virtual Wedbush PacGrow Healthcare Conference on August 11. Members of the management team will engage in a fireside chat at 3:30 PM ET, which will be streamed live and available for 90 days afterward. Edgewise specializes in developing innovative, orally bioavailable therapies for rare muscle disorders, leveraging its expertise in muscle biology and small molecule engineering to address significant unmet medical needs.

Edgewise Therapeutics (NASDAQ: EWTX), a clinical-stage biopharmaceutical company, announced its participation in two key conferences: the 2021 PPMD Annual Conference and the 2021 New Directions in Biology and Disease of Skeletal Muscle Conference.

The presentations will cover Edgewise's innovative therapies for Duchenne and Becker muscular dystrophies. Key speakers include Alan Russell, Ph.D., and Joanne Donovan, M.D., with sessions on June 23 and June 28, 2021, respectively. The talks will be available on the Edgewise website post-event.