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Details:

EDG-5506 (sevasemten) is an investigational orally administered small molecule, MYH4 inhibitor. It is being developed for the treatment of becker & duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2024

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EDG-5506 (sevasemten) is an orally administered small molecule designed to prevent contraction-induced muscle damage. Currently is being evaluated in clinical trials for the treatment of Duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2024

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Details:

EDG-5506 is an investigational orally administered small molecule, MYH4 inhibitor. It is being developed for the treatment of duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2024

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Details:

Edgewise intends to use the net proceeds to support the potential U.S. commercial launch of EDG-5506 (sevasemten), an orally administered skeletal myosin inhibitor, in patients with Becker muscular dystrophy and completion of a Phase 3 trial with EDG-5506 in Duchenne.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: RA Capital Management

Deal Size: $240.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering January 19, 2024

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Details:

EDG-5506 is a small molecule tablet which works by inhibiting Myosin ATPase, it is currently being investigated in adults for treating Becker Muscular Dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 30, 2023

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Details:

EDG-5506 is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Becker Muscular Dystrophy and Duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 26, 2023

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Details:

EDG-5506 is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Becker Muscular Dystrophy and Duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 26, 2023

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Details:

EDG-5506 is an orally administered small molecule designed to prevent contraction-induced muscle damage in dystrophinopathies including Becker Muscular Dystrophy and Duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Medpace, Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 26, 2023

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Details:

EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as DMD and Becker muscular dystrophy (BMD).


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2022

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Details:

EDG-5506 is an orally administered small molecule designed to address muscle damage induced by mechanical stress in dystrophinopathies including Becker and Duchenne Muscular Dystrophy (DMD and BMD).


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2022

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Details:

The total proceeds from the offering will be used for research and development of EDG-5506 and other products in clinical pipeline and for other general corporate purpose.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: J.P. Morgan

Deal Size: $138.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 16, 2022

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Details:

EDG-5506 is an orally administered small molecule designed to address muscle damage induced by mechanical stress in dystrophinopathies including DMD and BMD.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 11, 2022

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Details:

EDG-5506 is an orally administered small molecule designed to address muscle damage induced by mechanical stress in dystrophinopathies including DMD and BMD.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2022

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Details:

EDG-5506 is an orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as BMD and Duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 12, 2022

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Details:

Treatment with EDG-5506 led to a significant decrease in key biomarkers of muscle damage when assessed by laboratory assays. Importantly, creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2) were reduced by an average of 30% and 68%, respectively, after 2 months.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 20, 2022

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Details:

EDG-5506 is an orally administered small molecule designed to address muscle damage induced by mechanical stress in dystrophinopathies DMD and BMD, presents a novel mechanism of action to selectively limit exaggerated muscle damage caused by absence of functional dystrophin.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 16, 2022

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Details:

EDG-5506, an orally administered small molecule designed to address muscle damage induced by mechanical stress in dystrophinopathies including DMD and BMD. EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating rare neuromuscular disorders.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 14, 2022

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Details:

EDG-5506 is an orally administered investigational therapy small molecule, targets fast skeletal myosin to protect dystrophic muscle and reduce muscle damage biomarkers in a Phase 1 trial in becker muscular dystrophy and duchenne muscular dystrophy.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Muscular Dystrophy Association

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 08, 2022

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Details:

EDG-5506 treatment resulted in significant lowering of muscle damage biomarkers in adults with BMD after only two weeks of dosing and it was found to be well tolerated with no serious adverse events observed.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 05, 2022

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Details:

EDG-5506 is an orally administered small molecule designed to address the root cause of dystrophinopathies including DMD and BMD. EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating rare neuromuscular disorders.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 15, 2021

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Details:

EDG-5506, a selective, small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in DMD and BMD, is advancing in a Phase 1 clinical trial.


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 16, 2021

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Details:

The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics (PK) of EDG-5506 in adult healthy volunteers and in adults with Becker muscular dystrophy (BMD).


Lead Product(s): Sevasemten

Therapeutic Area: Genetic Disease Product Name: EDG-5506

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 11, 2020

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