Musculoskeletal | IND Enabling Drugs

Avidity Biosciences

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Avidity Biosciences Completes $100 Million Series C Financing

Lead Product(s): Antibody-Oligonucleotide Conjugates

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: RTW Investments

Deal Size: $100.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing May 26, 2020

Details:

The funds will enable Avidity to advance Company's growing proprietary portfolio of multiple programs, including Its AOC treatment of myotonic dystrophy type I, to treat serious muscle disorder.

Virpax Pharmaceuticals

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Virpax Completes Pre-IND Meeting with FDA on Epoladerm

Lead Product(s): Diclofenac Hydroxyethylpyrrolidine

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2020

Details:

FDA agreed that it is reasonable for Virpax to pursue a 505(b)(2) New Drug Application (NDA) for Epoladerm™, which is an abbreviated approval pathway allowing Virpax to reference safety and efficacy data of a reference listed drug.

Celavet

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Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA’s Center for Veterinary Medicine

Lead Product(s): OK100 stem cell

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 16, 2020

Details:

Celavet is submitting the study protocol to the CVM for Investigational New Animal Drug (INAD) status.

Cadent Therapeutics

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Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)

Lead Product(s): Cad-1883

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: IND Enabling Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 23, 2020

Details:

The Phase 2 trial is a multicenter, randomized, placebo-controlled study that will evaluate the safety and efficacy of CAD-1883. Efficacy outcome measures.

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Find FDA Investigational New Drug (IND) Submissions for Musculoskeletal

IND Enabling

Product Type

Companies

Avidity Biosciences

Avidity Biosciences Completes $100 Million Series C Financing

Virpax Pharmaceuticals

Virpax Completes Pre-IND Meeting with FDA on Epoladerm

Celavet

Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA’s Center for Veterinary Medicine

Cadent Therapeutics

Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)