SAN DIEGO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) today announced the Company will be presenting an update on its application for Orphan Drug status to the U.S. Food and Drug Administration (FDA) for HemaXellerate. This therapy is anticipated being used in treating aplastic anemia. Additionally the Company anticipates HemaXellerate may be used in addressing the side effects of Chemotherapy, a market of several billions of dollars. The Company’s Chairm ...

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].

Regen’s Approach Could Be Paradigm Shift in Supportive Oncology Care SAN DIEGO, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) today announced its ongoing efforts to expand the clinical development of HemaXellerate, its novel cellular therapy, to address chemotherapy-induced bone marrow suppression, a serious and common complication in cancer patients undergoing cytotoxic treatments. This represents potentially a market in excess of $1 billion per year in just the US. Following th ...

SAN DIEGO, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth. Regen sees substantial p ...

An Orphan Drug Designation Could Provide Significant Benefits to Regen SAN DIEGO, July 23, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC Pink: RGBP and RGBPP) today provides further insight into its planned Phase 1 clinical trial of HemaXellerate, the company's innovative stem cell-derived therapy, which has already received FDA Investigational New Drug Application (IND) clearance. While the initial focus is on treating aplastic anemia, Regen BioPharma is evaluating expanded applications for this grou ...