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

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[{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"ReGenTree","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RegeneRx Expects to Complete Short-Term Financing While Awaiting Completion of Phase 3 Clinical Trial for Dry Eye Syndrome","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"GtreeBNT","sponsor":"HLB Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RegeneRx Licensee Acquired by Korean Biopharmaceutical Group","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"SOUTH KOREA","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Clinical Results of RGN-259 for the Treatment of Neurotrophic Keratitis to be Presented at 2021 American Ophthalmology Association Meeting","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"ReGenTree","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Joint Venture Requests Pre-BLA Meeting with FDA For RGN-259 for Dry Eye Syndrome","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"T\u03b24 Shows Potential as a Combination Treatment for Diabetes-Induced Complications of the Cornea","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Licensee to Expand Phase 3 Clinical Trial Program with RGN-259","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"HLB Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Partner Signs LOI with Global Ophthalmology CRO for Two Phase 3 Clinical Trials in Neurotrophic Keratitis","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"HLB Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Partner Submits Phase 3 Protocol for Neurotrophic Keratopathy (NK)","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"RegeneRx Biopharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Licensee Submits Special Protocol Assessment to FDA for 4th Phase 3 Clinical Trial for Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"}]

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            Details:

            RGN-259 (timbetasin acetate) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 24, 2022

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            Details:

            RGN-259 (timbetasin acetate) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: HLB Therapeutics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 27, 2022

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            Details:

            RGN-259 (timbetasin acetate) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: HLB Therapeutics

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 18, 2022

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            Details:

            RGN-259 (timbetasin acetate) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 22, 2022

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            RGN-259, a Tβ4-based sterile and preservative-free eye drop, as a novel treatment for dry eye and neurotrophic keratitis (NK), a persistent corneal defect caused by diabetes and herpes zoster virus, among other pathologies.

            Lead Product(s): Timbetasin Acetate,Undisclosed

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Preclinical Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2022

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            Details:

            The purpose of a pre-BLA meeting is to discuss with FDA the format, content, and acceptability of RGN-259, a sterile, preservative-free eye drop that has been shown to reduce symptoms of dry eye syndrome based on the results to date.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: ReGenTree

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 29, 2021

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            Details:

            RGN-259 or Thymosin Beta 4 is timbetasin, a small peptide with G actin-sequestering action. It is associated with induction of angiogenesis, accelerated wound healing and increased metastatic potential of tumor cells.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 29, 2021

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            Details:

            Acquisition of GtreeBNT by HLB Group, would speed up the clinical trials currently in progress and allow the company to focus on new drug approval. RGN-259 will remain a priority for the company.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: HLB Group

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition September 27, 2021

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            Details:

            The funding will provide working capital through the first quarter of 2021 and while we await the completion of our phase 3 dry eye clinical trial (ARISE-3) expected later this year.

            Lead Product(s): Timbetasin Acetate

            Therapeutic Area: Ophthalmology Product Name: RGN-259

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: ReGenTree

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing October 12, 2020

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