Rochem International Inc Rochem International Inc

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Trial","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Immunis"},{"orgOrder":0,"company":"Avidity Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avidity Biosciences Receives FDA Orphan Drug Designation for AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Avidity Biosciences"},{"orgOrder":0,"company":"AnnJi Pharmaceutical","sponsor":"Avenue Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$3.0 million","newsHeadline":"Avenue Therapeutics Enters into a Transformational License Agreement with AnnJi Pharmaceutical to Develop and Commercialize AJ201, a First-in-Class Clinical Asset for the Treatment of Spinal and Bulbar Muscular Atrophy","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"AnnJi Pharmaceutical"},{"orgOrder":0,"company":"AnnJi Pharmaceutical","sponsor":"Avenue Therapeutics","pharmaFlowCategory":"D","amount":"$253.0 million","upfrontCash":"$3.0 million","newsHeadline":"AnnJi Pharmaceutical Announced A Licensing Agreement With Avenue Therapeutics To Develop And Commercialize AJ201, A First-In-Class Clinical Asset For The Treatment Of Kennedy's 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therapy","graph2":"Immunis"},{"orgOrder":0,"company":"SpineThera","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SpineThera Announces Breakthrough Market Research Results for SX600 in the Management of Sciatica Pain","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"SpineThera"},{"orgOrder":0,"company":"Avenue Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avenue Therapeutics Announces Completion of Enrollment in Phase 1b\/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Avenue Therapeutics"},{"orgOrder":0,"company":"Cabaletta Bio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cabaletta Bio Announces FDA Granted Orphan Drug Designation to CABA-201 for Treatment of Myositis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Cabaletta Bio"}]

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            Details:

            CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, which is being evaluated in phase 1/2 clinical trials for the treatment of idiopathic inflammatory myopathies (IIM, or myositis).

            Lead Product(s): CABA-201,Cyclophosphamide,Fludarabine Phosphate

            Therapeutic Area: Musculoskeletal Product Name: CABA-201

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 01, 2024

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            AJ201 is an oral Nrf1/Nrf2 stimulator which is under phase 1/2 clinical development for the treatment of patients with Spinal and Bulbar Muscular Atrophy (Kennedy's Disease).

            Lead Product(s): AJ201

            Therapeutic Area: Musculoskeletal Product Name: AJ201

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 02, 2024

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            SX600 (dexamethasone) is a novel formulation of extended-release microspheres designed for transforaminal epidural injection in the management of sciatica pain.

            Lead Product(s): Dexamethasone

            Therapeutic Area: Musculoskeletal Product Name: SX600

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 06, 2023

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            IMMUNA (IMM01-STEM) is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules, which is investigated for the treatment of Muscle Atrophy.

            Lead Product(s): IMM01-STEM

            Therapeutic Area: Musculoskeletal Product Name: IMMUNA

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 01, 2023

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            AJ201 is a novel first-in-class asset in development for the treatment of spinal and bulbar muscular atrophy. It was designed to modify SBMA through multiple mechanism including degradation of the abnormal androgen receptor protein and by stimulating the Nrf1 and Nrf2 pathway.

            Lead Product(s): AJ201

            Therapeutic Area: Musculoskeletal Product Name: AJ201

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: AnnJi Pharmaceutical

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 27, 2023

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            Lomecel-B, an allogeneic MSC therapy product isolated from the bone marrow of young, healthy adult donors. It is a pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects, it is being developed for aging-related frailty.

            Lead Product(s): Longeveron Mesenchymal Stem Cell

            Therapeutic Area: Musculoskeletal Product Name: Lomecel-B

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 19, 2023

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            Under the terms of the license agreement, avenue therapeutics will develop and commercialize AJ201, a first-in-class clinical asset for the treatment of kennedy's disease. AnnJi will retain the manufacturing right to provide clinical and commercial supply of AJ201 to avenue.

            Lead Product(s): AJ201

            Therapeutic Area: Musculoskeletal Product Name: AJ201

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Avenue Therapeutics

            Deal Size: $253.0 million Upfront Cash: $3.0 million

            Deal Type: Licensing Agreement March 10, 2023

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            Under the agreement, Avenue Therapeutics will Develop and Commercialize AJ201, a first-in-class clinical asset currently in a Phase 1b/2a study in the U.S. for the treatment of spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease.

            Lead Product(s): AJ201

            Therapeutic Area: Musculoskeletal Product Name: AJ201

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Avenue Therapeutics

            Deal Size: Undisclosed Upfront Cash: $3.0 million

            Deal Type: Licensing Agreement March 02, 2023

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            AOC 1020 consists of a proprietary monoclonal antibody that binds to the transferrin receptor 1 (TfR1) conjugated with a siRNA targeting DUX4 mRNA to reduce the expression of DUX4 mRNA and DUX4 protein in muscles in patients with FSHD.

            Lead Product(s): AOC 1020

            Therapeutic Area: Musculoskeletal Product Name: AOC 1020

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 14, 2023

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            IMM01-STEM, a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules, in participants with muscle atrophy related to knee osteoarthritis (KOA).

            Lead Product(s): IMM01-STEM

            Therapeutic Area: Musculoskeletal Product Name: IMM01-STEM

            Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 24, 2023

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