Market Overview

RegeneRx Announces Orphan Drug Designation for Tβ4 for Treatment of Neurotrophic Keratopathy


RegeneRx Biopharmaceuticals (OTC: RGRX) announced that it has received Orphan Drug designation from
U.S. FDA's Office of Orphan Products Development (OOPD) for its drug
candidate, Thymosin beta 4 (Tβ4), for the treatment of Neurotrophic
Keratopathy (NK), a serious degenerative disease of the corneal
epithelium (the outside layer of the eye). A reduction in corneal
sensitivity or complete corneal anesthesia is the hallmark of this
disease and is responsible for producing corneal ulceration,
perforation, pain and impaired vision. The designation, for novel drugs
to treat diseases with a prevalence of less than 200,000 patients in the
U.S., provides seven years of extended marketing exclusivity, waiver of
FDA user fees, tax credits of up to 50% of qualified clinical

See full press release

Posted-In: News Guidance Management Global


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