RGN-259 regulatory update

RegeneRx said FDA granted Orphan Drug designation for thymosin beta 4 (TB4), the API in RGN-259, to treat neurotrophic keratitis, a progressive degenerative disease of the cornea that may result in blindness. RGN-259 is a topical eye drop formulation of TB4, a naturally occurring 43-amino acid peptide. RGN-259 was evaluated under a compassionate use IND for the indication and is also in Phase II testing for dry eye syndrome. The company declined to disclose a timeline for next steps for RGN-259, but said it is looking for partners for its drug candidates...