Regenerx Biopharmaceuticals Inc is a Delaware corporation, was incorporated in 1982. The Company a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair, and regeneration. It has formulated Tß4 into three distinct product candidates in clinical development namely RGN-259, a topical eye drop for regeneration of corneal tissues damaged by injury, disease or other pathology; RGN-352, an injectable formulation to treat cardiovascular diseases, central and peripheral nervous system diseases, and other medical indications that may be treated by systemic administration; and RGN-137, a topical gel for dermal wounds and reduction of scar tissue. In addition to its four pharmaceutical product candidates, it is also pursuing the commercial development of peptide fragments and derivatives of Tß4 for potential cosmeceutical use. These fragments are amino acid sequences, and variations thereof, within the Tß4 molecule that has demonstrated activity in several in vitro preclinical research studies that it has sponsored. In the United States, the Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder and other federal and state statutes and regulations govern, among other things, the testing, manufacturing, labeling, storing, recordkeeping, distribution, advertising and promotion of the Company's product candidates.
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