Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate

Core Viewpoint - Regen BioPharma is addressing comments from the FDA regarding its Orphan Drug Application for HemaXellerate, aimed at treating aplastic anemia, a rare and serious bone marrow disorder [1][3]. Company Overview - Regen BioPharma, Inc. is a publicly traded biotechnology company focused on immunology and immunotherapy, advancing novel technologies through pre-clinical and Phase I/II clinical trials [8]. Product Details - HemaXellerate is a novel, cell-based therapeutic designed to stimulate bone marrow activity and restore hematopoietic function, representing a significant milestone in the company's mission to develop innovative therapies for patients with limited options [2][5]. - The product is an autologous mesenchymal stem cell product expected to reverse the effects of aplastic anemia-induced bone marrow suppression [5]. Regulatory Aspects - The Orphan Drug Application is a major step for the company, as receiving orphan drug designation from the FDA would provide regulatory and commercial advantages, including seven years of market exclusivity, tax credits for clinical testing, and exemption from certain FDA application fees [3][4]. Market Context - Aplastic anemia is characterized by insufficient blood cell production, leading to severe health issues such as fatigue and infections, with current treatment options being limited and often ineffective [4].