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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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct 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 IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
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