Sernova_Biotherapeutics gets FDA Orphan Drug

Atara Biotherapeutics announced that the United States — Food and Drug Administration granted Orphan Drug Designation for autologous islet transplantation (AIT) for the prevention of diabetes due to total pancreatectomy. This designation supports the development of drugs for rare diseases and provides Atara Biotherapeutics with potential benefits including seven years of market exclusivity in the United States upon regulatory approval, tax credits for clinical testing, and waiver of certain FDA user fees. The company's Cell Pouch Bio-hybrid Organ is central to this treatment, aiming to preserve insulin production and prevent post-surgical diabetes without immune suppression. Jonathan Cran, CEO of Atara Biotherapeutics, emphasized that this designation provides a potential exclusive lead position in preventing type 3c diabetes, a natural extension of their focus on type 1 diabetes.