X
[{"orgOrder":0,"company":"ReGenTree","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ReGenTree Announces Efficacy Results of the Neurotrophic Keratopathy Phase 3 Clinical Trial with RGN-259","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"ReGenTree","sponsor":"RegeneRx Biopharmaceuticals","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":"ReGenTree","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Joint Venture Enrolls Last Subject in Phase 3 Dry Eye Trial","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":"ReGenTree","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Last Patient, Last Visit Completed in RegeneRx Phase 3 Dry Eye Clinical Trial","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"ReGenTree","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RegeneRx Joint Venture Reports Positive Results from ARISE-3 Clinical Trial Using RGN-259 to Treat Dry Eye Syndrome","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"ReGenTree","sponsor":"RegeneRx Biopharmaceuticals","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"}]
Find Clinical Drug Pipeline Developments & Deals by ReGenTree
Filters
Companies By Therapeutic Area
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
Recipient:
RegeneRx Biopharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
November 29, 2021
Details:
Completed analysis demonstrated a number of favorable efficacy parameters in ARISE-3 and, most importantly, numerous significant sign and symptom improvements with RGN-259 when pooling the patient data from all three phase 3 clinical trials.
Lead Product(s):
Thymosin Beta-4
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
May 14, 2021
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
Lead Product(s):
Thymosin Beta-4
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
November 09, 2020
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
Lead Product(s):
Thymosin Beta-4
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 28, 2020
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
Recipient:
RegeneRx Biopharmaceuticals
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Financing
October 12, 2020
Details:
Six out of 10 patients in the RGN-259 treated group and 1 out of 8 patients in the placebo treated group achieved complete corneal healing in 4 weeks.
Lead Product(s):
Thymosin Beta-4
Therapeutic Area: Ophthalmology
Product Name: Undisclosed
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
May 14, 2020