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Edgewise (EWTX) Up 9.37% on Positive Data From BMD Study
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Shares of Edgewise Therapeutics, Inc., (EWTX - Free Report) gained 9.37% after management announced positive interim results from the ongoing ARCH study of the lead candidate EDG-5506 in adults with Becker Muscular Dystrophy (BMD) post four months of treatment.
BMD is a serious, progressively debilitating and potentially fatal inherited X-linked neuromuscular disorder. EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, such as Duchenne muscular dystrophy (DMD) and BMD.
Edgewise completed the phase I study of EDG-5506 designed to evaluate safety, tolerability, and pharmacodynamics (PK) of EDG-5506 in adult healthy volunteers (phase Ia) and adults with BMD (phase Ib) (NCT04585464). ARCH is a follow-on open-label study assessing long-term safety and PK, plus decreases in biomarkers of muscle damage.
The daily dose was escalated to 15 mg oral doses of EDG-5506 at night for the 12 patients enrolled. These patients had initially received a 10 mg dose during the first couple of months of the study.
Treatment with EDG-5506 led to a significant decrease in key biomarkers of muscle damage when assessed by laboratory assays. Plasma PK at the end of four months reached the target exposures observed in the phase Ib study, where BMD participants were dosed with 20 mg EDG-5506 once-daily for two weeks. The candidate was well-tolerated. Creatine kinase (CK) and fast skeletal muscle troponin I were reduced by an average of 29% and 74%, respectively, after four months.
After four months of EDG-5506 dosing, North Star Ambulatory Assessment scale (NSAA) increased by an average of 1.17 points compared to the pre-therapy baseline. Nine participants either showed a functional improvement or no decline on NSAA relative to their baselines.
Shares have lost 11.1% so far in the year compared with the industry's decline of 20.9%.
Image Source: Zacks Investment Research
The FDA granted a Fast Track designation to EDG-5506 for treating individuals with BMD.
CANYON is a phase II study assessing safety, PK, biomarkers and functional measures in participants with BMD. The FDA recently authorized LYNX, a phase II trial of EDG-5506, to treat DMD that will assess safety, PK and biomarkers of muscle damage.
The successful development of the candidate will significantly boost this clinical-stage entity.
EWTX is also advancing the EDG-002 program, focused on identifying cardiac muscle modulators with a novel mechanism of action, initially targeting inherited hypertrophic cardiomyopathy (HCM).
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed on earnings in three of the trailing four quarters and missed on the same in the remaining one, the average beat being 2.39%.
Loss estimates for ZEAL have narrowed to $3.19 from $3.57 in the past 60 days. ZEAL surpassed on earnings in all the trailing four quarters, the average being 22.02%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.
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Edgewise (EWTX) Up 9.37% on Positive Data From BMD Study
Shares of Edgewise Therapeutics, Inc., (EWTX - Free Report) gained 9.37% after management announced positive interim results from the ongoing ARCH study of the lead candidate EDG-5506 in adults with Becker Muscular Dystrophy (BMD) post four months of treatment.
BMD is a serious, progressively debilitating and potentially fatal inherited X-linked neuromuscular disorder. EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, such as Duchenne muscular dystrophy (DMD) and BMD.
Edgewise completed the phase I study of EDG-5506 designed to evaluate safety, tolerability, and pharmacodynamics (PK) of EDG-5506 in adult healthy volunteers (phase Ia) and adults with BMD (phase Ib) (NCT04585464). ARCH is a follow-on open-label study assessing long-term safety and PK, plus decreases in biomarkers of muscle damage.
The daily dose was escalated to 15 mg oral doses of EDG-5506 at night for the 12 patients enrolled. These patients had initially received a 10 mg dose during the first couple of months of the study.
Treatment with EDG-5506 led to a significant decrease in key biomarkers of muscle damage when assessed by laboratory assays. Plasma PK at the end of four months reached the target exposures observed in the phase Ib study, where BMD participants were dosed with 20 mg EDG-5506 once-daily for two weeks. The candidate was well-tolerated. Creatine kinase (CK) and fast skeletal muscle troponin I were reduced by an average of 29% and 74%, respectively, after four months.
After four months of EDG-5506 dosing, North Star Ambulatory Assessment scale (NSAA) increased by an average of 1.17 points compared to the pre-therapy baseline. Nine participants either showed a functional improvement or no decline on NSAA relative to their baselines.
Shares have lost 11.1% so far in the year compared with the industry's decline of 20.9%.
Image Source: Zacks Investment Research
The FDA granted a Fast Track designation to EDG-5506 for treating individuals with BMD.
CANYON is a phase II study assessing safety, PK, biomarkers and functional measures in participants with BMD. The FDA recently authorized LYNX, a phase II trial of EDG-5506, to treat DMD that will assess safety, PK and biomarkers of muscle damage.
The successful development of the candidate will significantly boost this clinical-stage entity.
EWTX is also advancing the EDG-002 program, focused on identifying cardiac muscle modulators with a novel mechanism of action, initially targeting inherited hypertrophic cardiomyopathy (HCM).
Edgewise currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) , Zealand Pharma and Dynavax (DVAX - Free Report) , all carrying a Zacks Rank #2 (Buy), currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed on earnings in three of the trailing four quarters and missed on the same in the remaining one, the average beat being 2.39%.
Loss estimates for ZEAL have narrowed to $3.19 from $3.57 in the past 60 days. ZEAL surpassed on earnings in all the trailing four quarters, the average being 22.02%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.