[{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Diclofenac","moa":"COX-1\/COX2","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Virpax Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Topical Spray","sponsorNew":"Virpax Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Virpax Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Kindeva Drug Delivery","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2022","type":"Inapplicable","leadProduct":"Diclofenac","moa":"COX-1\/COX2","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Virpax Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Topical Spray","sponsorNew":"Virpax Pharmaceuticals \/ Kindeva Drug Delivery","highestDevelopmentStatusID":"5","companyTruncated":"Virpax Pharmaceuticals \/ Kindeva Drug Delivery"},{"orgOrder":0,"company":"MMJ International Holding","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2024","type":"Inapplicable","leadProduct":"MMJ-002","moa":"Undisclosed","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"MMJ International Holding","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"MMJ International Holding \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"MMJ International Holding \/ Inapplicable"},{"orgOrder":0,"company":"Arugula Sciences","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2023","type":"Inapplicable","leadProduct":"SIG002","moa":"Undisclosed","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Arugula Sciences","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Intra-articular Injection","sponsorNew":"Arugula Sciences \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Arugula Sciences \/ Inapplicable"},{"orgOrder":0,"company":"Adicet Bio","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2024","type":"Inapplicable","leadProduct":"ADI-001","moa":"CD20","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Adicet Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Adicet Bio \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Adicet Bio \/ Inapplicable"},{"orgOrder":0,"company":"Celularity","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2024","type":"Inapplicable","leadProduct":"PDA-002","moa":"Undisclosed","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Celularity","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Intramuscular Injection","sponsorNew":"Celularity \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Celularity \/ Inapplicable"},{"orgOrder":0,"company":"Epic Bio","sponsor":"SOLVE FSHD","pharmaFlowCategory":"D","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2023","type":"Financing","leadProduct":"EPI-321","moa":"DUX4 expression","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Epic Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Epic Bio \/ SOLVE FSHD","highestDevelopmentStatusID":"5","companyTruncated":"Epic Bio \/ SOLVE FSHD"},{"orgOrder":0,"company":"Epicrispr Biotechnologies","sponsor":"Ally Bridge Group","pharmaFlowCategory":"D","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2025","type":"Series B Financing","leadProduct":"EPI-321","moa":"DUX4 expression","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Epicrispr Biotechnologies","amount2":0.070000000000000007,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0.070000000000000007,"dosageForm":"Intravenous Injection","sponsorNew":"Epicrispr Biotechnologies \/ Ally Bridge Group","highestDevelopmentStatusID":"5","companyTruncated":"Epicrispr Biotechnologies \/ Ally Bridge Group"},{"orgOrder":0,"company":"Epic Bio","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2022","type":"Inapplicable","leadProduct":"EPI-321","moa":"DUX4 expression","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Epic Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Epic Bio \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Epic Bio \/ Inapplicable"},{"orgOrder":0,"company":"Epic Bio","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2022","type":"Inapplicable","leadProduct":"EPI-321","moa":"DUX4 expression","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Epic Bio","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Intravenous Injection","sponsorNew":"Epic Bio \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Epic Bio \/ Inapplicable"},{"orgOrder":0,"company":"Avidity Biosciences","sponsor":"RTW Investments","pharmaFlowCategory":"D","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Large Molecule","year":"2020","type":"Series C Financing","leadProduct":"Undisclosed","moa":"DMPK","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Avidity Biosciences","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Avidity Biosciences \/ RTW Investments","highestDevelopmentStatusID":"5","companyTruncated":"Avidity Biosciences \/ RTW Investments"},{"orgOrder":0,"company":"GQ Bio Therapeutics","sponsor":"Pacira BioSciences","pharmaFlowCategory":"D","therapeuticArea":"Musculoskeletal","country":"GERMANY","productType":"Cell and Gene therapy","year":"2025","type":"Acquisition","leadProduct":"GQ-501","moa":"PRG4","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"GQ Bio Therapeutics","amount2":0.029999999999999999,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0.029999999999999999,"dosageForm":"Intra-articular Injection","sponsorNew":"GQ Bio Therapeutics \/ Pacira BioSciences","highestDevelopmentStatusID":"5","companyTruncated":"GQ Bio Therapeutics \/ Pacira BioSciences"},{"orgOrder":0,"company":"MiMedx","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2021","type":"Inapplicable","leadProduct":"Micronized Dehydrated Human Amnion Chorion Membrane","moa":"Undisclosed","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"MiMedx","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Oral Inhalation","sponsorNew":"MiMedx \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"MiMedx \/ Inapplicable"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2020","type":"Inapplicable","leadProduct":"Diclofenac","moa":"COX-1\/COX2","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Virpax Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Topical Film","sponsorNew":"Virpax Pharmaceuticals \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Virpax Pharmaceuticals \/ Inapplicable"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"D","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Other Small Molecule","year":"2021","type":"Public Offering","leadProduct":"Diclofenac","moa":"COX-1\/COX2","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Virpax Pharmaceuticals","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Topical Film","sponsorNew":"Virpax Pharmaceuticals \/ Undisclosed","highestDevelopmentStatusID":"5","companyTruncated":"Virpax Pharmaceuticals \/ Undisclosed"},{"orgOrder":0,"company":"Celavet","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Musculoskeletal","country":"U.S.A","productType":"Cell and Gene therapy","year":"2020","type":"Inapplicable","leadProduct":"OK100 Stem Cell","moa":"Undisclosed","graph1":"Musculoskeletal","graph2":"IND Enabling","graph3":"Celavet","amount2":0,"highestDevelopmentShortName":"IND","therapeuticAreaShortName":"Musculoskeletal","amount2New":0,"dosageForm":"Undisclosed","sponsorNew":"Celavet \/ Inapplicable","highestDevelopmentStatusID":"5","companyTruncated":"Celavet \/ Inapplicable"}]

Find FDA Investigational New Drug (IND) Submissions for Musculoskeletal

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                          Top Deals by Deal Size (USD bn)

                          01

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : The financing aims to fund the clinical development of lead program, EPI-321. It is being evaluated for the treatment of facioscapulohumeral muscular dystrophy.

                          Product Name : EPI-321

                          Product Type : Cell and Gene therapy

                          Upfront Cash : Undisclosed

                          March 26, 2025

                          Lead Product(s) : EPI-321

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Ally Bridge Group

                          Deal Size : $68.0 million

                          Deal Type : Series B Financing

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                          02

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : Through the acquisition, Pacira will leverage musculoskeletal portfolio, which includes GQ-501 is a helper-dependent adenoviral vector expressing proteoglycan 4 & being developed for osteoarthritis.

                          Product Name : GQ-501

                          Product Type : Cell and Gene therapy

                          Upfront Cash : $18.0 million

                          February 27, 2025

                          Lead Product(s) : GQ-501

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Pacira BioSciences

                          Deal Size : $32.0 million

                          Deal Type : Acquisition

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                          03

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : MMJ-002 is a novel cannabis-derived medication, being investigated for the treatment of chorea associated with Huntington's disease (HD).

                          Product Name : MMJ-002

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          December 10, 2024

                          Lead Product(s) : MMJ-002

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          04

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : FDA has agreed to an amendment to the company’s investigational new drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome.

                          Product Name : ADI-001

                          Product Type : Cell and Gene therapy

                          Upfront Cash : Inapplicable

                          October 16, 2024

                          Lead Product(s) : ADI-001

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          05

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : PDA-002 is a placenta-derived mesenchymal-like adherent stromal cell therapy, which is being evaluated for the treatment of facioscapulohumeral muscular dystrophy.

                          Product Name : PDA-002

                          Product Type : Cell and Gene therapy

                          Upfront Cash : Inapplicable

                          March 20, 2024

                          Lead Product(s) : PDA-002

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          06

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : ARO-DUX4 is an investigational RNAi therapeutic designed to reduce expression of the gene that encodes the human double homeobox 4 (DUX4) protein as a potential treatment for FSHD.

                          Product Name : ARO-DUX4

                          Product Type : Oligonucleotide

                          Upfront Cash : Inapplicable

                          July 17, 2023

                          Lead Product(s) : ARO-DUX4

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          07

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : The investment will support development of Epic’s lead program EPI-321, a novel therapeutic that is designed to correct the epigenetic alterations in the D4Z4 region of chromosome 4.

                          Product Name : EPI-321

                          Product Type : Cell and Gene therapy

                          Upfront Cash : Undisclosed

                          April 18, 2023

                          Lead Product(s) : EPI-321

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : SOLVE FSHD

                          Deal Size : Undisclosed

                          Deal Type : Financing

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                          08

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : SIG002 consists purified secretome free of tissue fragments and cells. SIG002 has demonstrated immunoregulatory properties relevant to address the degenerative inflammatory processes involved in osteoarthritis disease etiology.

                          Product Name : SIG002

                          Product Type : Cell and Gene therapy

                          Upfront Cash : Inapplicable

                          January 31, 2023

                          Lead Product(s) : SIG002

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          09

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : FSD201 is a proprietary formulation of ultra-micronized palmitoylethanolamide (PEA). FSD Pharma’s successfully completed Phase 1 clinical trial showed FSD201 to be safe and well tolerated.

                          Product Name : FSD201

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          June 09, 2022

                          Lead Product(s) : Palmitoylethanolamide

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          10

                          German Wound Congress
                          Not Confirmed
                          German Wound Congress
                          Not Confirmed

                          Details : Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee.

                          Product Name : Epoladerm

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          April 27, 2022

                          Lead Product(s) : Diclofenac

                          Therapeutic Area : Musculoskeletal

                          Highest Development Status : IND Enabling

                          Sponsor : Kindeva Drug Delivery

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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