Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 27, 2022
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Recipient : RegeneRx Biopharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
RegeneRx Joint Venture Requests Pre-BLA Meeting with FDA For RGN-259 for Dry Eye Syndrome
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
November 29, 2021
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Recipient : RegeneRx Biopharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 14, 2021
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Recipient : RegeneRx Biopharmaceuticals
Deal Size : Undisclosed
Deal Type : Financing
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Undisclosed
December 10, 2020
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Recipient : RegeneRx Biopharmaceuticals
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
RegeneRx Joint Venture Enrolls Last Subject in Phase 3 Dry Eye Trial
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
October 28, 2020
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Last Patient, Last Visit Completed in RegeneRx Phase 3 Dry Eye Clinical Trial
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 11, 2020
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 14, 2020
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 06, 2019
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
November 29, 2016
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
November 09, 2015
Lead Product(s) : Timbetasin Acetate
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable