Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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Continues Consultations with the UK MHRA and Initiates a Type C Meeting Request with the US FDA","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"180 Life Sciences"},{"orgOrder":0,"company":"Tonix Pharmaceuticals Holding Corp","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Tonix Pharmaceuticals Holding Corp"},{"orgOrder":0,"company":"Virios Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virios Therapeutics Announces Plans to Advance Lead Candidate IMC-1 to Phase 3 Development as a New Treatment Option for Fibromyalgia","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Virios Therapeutics"},{"orgOrder":0,"company":"180 Life Sciences","sponsor":"Alliance Global Partners","pharmaFlowCategory":"D","amount":"$3.0 million","upfrontCash":"Undisclosed","newsHeadline":"180 Life Sciences Corp. Announces Pricing of $3 Million Public Offering","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"180 Life Sciences"},{"orgOrder":0,"company":"180 Life Sciences","sponsor":"Alliance Global Partners","pharmaFlowCategory":"D","amount":"$3.0 million","upfrontCash":"Undisclosed","newsHeadline":"180 Life Sciences Corp. Announces Closing of $3 Million Public Offering","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"180 Life Sciences"},{"orgOrder":0,"company":"Saol therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saol Therapeutics Announces Completion of Enrollment in Both the Phase II COMPASS Osteoarthritis Knee Pain Trial and the Phase II RAISE Limb Spasticity Trial","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Undisclosed","graph2":"Saol therapeutics"},{"orgOrder":0,"company":"Biophytis","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Biophytis Obtains FDA Authorization to Initiate the SARA-31 Phase 3 Study in Sarcopenia","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Biophytis"},{"orgOrder":0,"company":"OliPass","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OliPass Discloses Painful but Hilarious Clinical Findings from a Phase 2a Trial in OA Patients with Nav1.7 Selective Inhibitor OLP-1002","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"OliPass"},{"orgOrder":0,"company":"Tryp Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tryp Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial for the Treatment of Fibromyalgia at The University of Michigan","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Tryp Therapeutics"},{"orgOrder":0,"company":"Eupraxia Pharmaceuticals","sponsor":"Raymond James Ltd","pharmaFlowCategory":"D","amount":"$33.9 million","upfrontCash":"Undisclosed","newsHeadline":"Eupraxia Pharmaceuticals Announces Closing of Overnight Marketed Offering for Gross Proceeds of C$33.9 Million","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Eupraxia Pharmaceuticals"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"Eupraxia Pharmaceuticals","sponsor":"Raymond James Ltd","pharmaFlowCategory":"D","amount":"$30.0 million","upfrontCash":"Undisclosed","newsHeadline":"Eupraxia Pharmaceuticals Announces Overnight Marketed Offering of Approximately $30 Million","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Eupraxia Pharmaceuticals"},{"orgOrder":0,"company":"EnteraBio Ltd","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera's Next Generation Oral Peptide Platform","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Peptide","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Peptide","graph2":"EnteraBio Ltd"},{"orgOrder":0,"company":"Levicept","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Levicept Completes Recruitment in Phase II Clinical Trial of Neurotrophin Modulator LEVI-04","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Levicept"},{"orgOrder":0,"company":"Biorestorative Therapies","sponsor":"Galen Patient Recruitment","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Biorestorative Therapies"}]

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            The partnership aims to accelerate the completion of patient enrollment in the ongoing Phase 2 study of BioRestorative's primary clinical candidate, BRTX-100, for chronic lumbar disc disease.

            Lead Product(s): BRTX-100

            Therapeutic Area: Musculoskeletal Product Name: BRTX-100

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

            Partner/Sponsor/Collaborator: Galen Patient Recruitment

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership April 08, 2024

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            EB613 (teriparatide) is the first and most advanced oral, daily tablet formulation of synthetic hPTH (1-34), which is being evaluated for the treatment of osteoporosis.

            Lead Product(s): Teriparatide

            Therapeutic Area: Musculoskeletal Product Name: EB613

            Highest Development Status: Phase II Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 26, 2024

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            The net proceeds will be used in the development of EP-104IAR (fluticasone propionate), which is a GR-agonist. Currently, it is being evaluated in the Phase II clinical trial studies for the treatment of Osteoarthritis.

            Lead Product(s): Fluticasone Propionate

            Therapeutic Area: Musculoskeletal Product Name: EP-104IAR

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Raymond James Ltd

            Deal Size: $33.9 million Upfront Cash: Undisclosed

            Deal Type: Public Offering March 15, 2024

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            Eupraxia expects to use the net proceeds to fund research and development activities, including EP-104IAR, a novel, sustained-release, intra-articular (IA) formulation of the corticosteroid fluticasone propionate, being developed for the treatment of Osteoarthritis.

            Lead Product(s): Fluticasone Propionate

            Therapeutic Area: Musculoskeletal Product Name: EP-104IAR

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Raymond James Ltd

            Deal Size: $30.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering March 11, 2024

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            LEVI-04 is a novel neurotrophin-modulating biological agent. It is under phase 2 clinical development for the treatment of chronic pain in patients with osteoarthritis.

            Lead Product(s): LEVI-04

            Therapeutic Area: Musculoskeletal Product Name: LEVI-04

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 13, 2023

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            TRP-8802 (psilocybin) is a 5-HT2A receptor agonist - oral formulation which is being evaluated in phase 2 clinical studies for the treatment of fibromyalgia.

            Lead Product(s): Psilocybine

            Therapeutic Area: Musculoskeletal Product Name: TRP-8802

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 04, 2023

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