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[{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Novartis Pharmaceuticals Corporation"},{"orgOrder":0,"company":"Celavet","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celavet Inc. Plans Submission of Equine Tendinitis Study to FDA\u2019s Center for Veterinary Medicine ","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Celavet"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virpax Completes Pre-IND Meeting with FDA on Epoladerm","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Virpax Pharmaceuticals"},{"orgOrder":0,"company":"Avidity Biosciences","sponsor":"RTW Investments","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Avidity Biosciences Completes $100 Million Series C Financing","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"Undisclosed","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Avidity Biosciences"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"Virpax \u00ae Pharmaceuticals Announces Closing of a $ 40 Million Public Offering of Common Stock","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Virpax Pharmaceuticals"},{"orgOrder":0,"company":"MiMedx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Two New Studies Demonstrate In Vitro Bioactivity Potential of Micronized Dehydrated Human Amnion Chorion Membrane (mdHACM) to Prevent Pathological Processes Underlying Osteoarthritis (OA) and Tendinopathy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"MiMedx"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virpax Completes All FDA-Required Pre-Clinical Studies for Epoladerm","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Virpax Pharmaceuticals"},{"orgOrder":0,"company":"Virpax Pharmaceuticals","sponsor":"Kindeva Drug Delivery","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virpax Pharmaceuticals Selects Kindeva Drug Delivery as Development Partner for Diclofenac pMDI Commercialization","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Virpax Pharmaceuticals"},{"orgOrder":0,"company":"FSD Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA and Health Canada Clear IND for FSD Pharma to Proceed with Phase 2 Trial of FSD201 for Nociplastic Pain Associated with Idiopathic Mast Cell Activation Syndrome","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"FSD Pharma"},{"orgOrder":0,"company":"SiSaf","sponsor":"CSSi LifeSciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SiSaf's Innovative RNA Therapeutic for Rare Genetic Skeletal Disorders Begins the U.S. Regulatory Process for Orphan Drug Designation","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"SiSaf"},{"orgOrder":0,"company":"Arugula Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Arugula Sciences Announces FDA Approval to Proceed with Phase 1 Study of SIG002, a Perinatal-derived Secretome Product, for the Treatment of Big Toe Osteoarthritis (Hallux Rigidus)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Arugula Sciences"},{"orgOrder":0,"company":"Epic Bio","sponsor":"Solve FSHD","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"SOLVE FSHD Invests in Epic Bio for The Development of A Novel Treatment for Facioscapulohumeral Muscular Dystrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Epic Bio"},{"orgOrder":0,"company":"SiSaf","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants SiSaf\u2019s Innovative siRNA Therapy SIS-101-ADO Orphan Drug Designation and Rare Pediatric Disease Designation for the Treatment of Autosomal Dominant Osteopetrosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"SiSaf"},{"orgOrder":0,"company":"Arrowhead Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate a Phase 1\/2 Study of ARO-DUX4 for Facioscapulohumeral Muscular Dystrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Arrowhead Pharmaceuticals"},{"orgOrder":0,"company":"Celularity","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Celularity"}]

Find FDA Investigational New Drug (IND) Submissions for Musculoskeletal

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

            Lead Product(s): PDA-002

            Therapeutic Area: Musculoskeletal Product Name: PDA-002

            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 20, 2024

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            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.

            Lead Product(s): ARO-DUX4

            Therapeutic Area: Musculoskeletal Product Name: ARO-DUX4

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 17, 2023

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            SIS-101-ADO is an siRNA that suppresses the expression of CLCN7, a mutant gene expressed by osteoclasts and other cell types responsible for causing ADO2, the RNA therapy restores bone mass and quality to nearly normal levels.

            Lead Product(s): SIS-101-ADO

            Therapeutic Area: Musculoskeletal Product Name: SIS-101-ADO

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2023

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            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.

            Lead Product(s): EPI-321

            Therapeutic Area: Musculoskeletal Product Name: EPI-321

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

            Partner/Sponsor/Collaborator: Solve FSHD

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing April 18, 2023

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            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.

            Lead Product(s): SIG002

            Therapeutic Area: Musculoskeletal Product Name: SIG002

            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 January 31, 2023

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            SIS-101-ADO combines an siRNA that suppress expression of CLCN7, with SiSaf’s Bio-Courier® next generation silicon stabilized hybrid lipid nanoparticles technology of other RNA delivery technologies by merging LNP technology with inorganic bioabsorbable silicon.

            Lead Product(s): SIS-101-ADO

            Therapeutic Area: Musculoskeletal Product Name: SIS-101-ADO

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: CSSi LifeSciences

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 12, 2022

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            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.

            Lead Product(s): Palmitoylethanolamide

            Therapeutic Area: Musculoskeletal Product Name: FSD201

            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 September 06, 2022

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            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.

            Lead Product(s): Diclofenac Epolamine

            Therapeutic Area: Musculoskeletal Product Name: Epoladerm

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Kindeva Drug Delivery

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 27, 2022

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            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.

            Lead Product(s): Diclofenac Epolamine

            Therapeutic Area: Musculoskeletal Product Name: Epoladerm

            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 March 22, 2022

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            Data show mdHACM mitigates effects of inflammatory-induced degeneration in chondrocytes, the Primary Cell Type in Cartilage. These results further support mdHACM as an investigational new drug candidate for the treatment of OA and highlight potential disease activities.

            Lead Product(s): Micronized Dehydrated Human Amnion Chorion Membrane

            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 November 01, 2021

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