HCell Inc.
BioTech/Drugs - Austin, TX, US
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HCell Granted Orphan Drug Designation from the U.S. FDA for HC017AA Alopecia Areata in the Pediatric PopulationAustin, Texas – December 22, 2017 – HCell Inc., a privately held biotechnology company based in Austin, Texas, focusing on Alopecia Areata in the Pediatric Population, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to HC017AA for the treatment of pediatric patients with alopecia areata, a devastating hair loss disease. "The granting of Orphan Drug status by the U.S. FDA is a significant milestone for HCell in the HC017AA development program," said Jaehyun Lim M.D., Ph.D, co-founder and Chief Science Officer at HCell Inc. "We are working diligently to get ready to conduct the clinical study for this significant, yet unmet, medical need for alopecia areata in pediatric patients." The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, which is defined as those affecting fewer than 200,000 people, in the U.S. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to advance scientific development of such promising medical products. "ODD from the FDA's recognition gives HCell Inc. a number of potential financial benefits and is aligned with our ongoing work seeking expedited pathways towards product approval in the U.S.," Dr. Lim added.HCell Inc. is also working on initiating regulatory steps for HC0100, which comprises proprietary composition and procedure for the treatment of Androgenic Alopecia conditions in both men and women. Further, HCell Inc. is planning pre-clinical development with the intent to launch a human clinical study in the U.S.For more information, visit www.hcell.net.
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