Business
Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product
Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product.
About this update from Regen Biopharma, Inc.
[{"type":"text","content":"\r\n\r\n \r\n \r\n Regen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product\r\n \r\n \r\n\r\n\r\nRegen BioPharma, Inc. to Seek Orphan Drug Designation for Lead Product\r\n\r\n\r\n\r\n\r\n\r\nAn 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 groundbreaking therapy in a market poised for significant growth. David Koos, the Chairman and CEO of Regen Biopharma, Inc., discussed the Company’s intention to seek Orphan Drug Designation for HemaXellerate, the Company’s proprietary aplastic anemia cell therapy drug candidate. This designation supports the development of medicines for rare disorders  “The incentives gained by being granted Orphan Drug designation would be substantial,” stated Koos. “These incentives include a tax credit equal to 25% of qualified clinical testing expenses (QCTEs) as well as up to seven years of marketing exclusivity. Regen intends to vigorously pursue Orphan Drug designation for HemaXellerate.” The Company has been granted clearance by the United States FDA to initiate a Phase I clinical trial for HemaXellerate. HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells. HemaXellerate™ is designed to stimulate bone marrow regeneration following injury caused by autoimmune conditions, chemotherapy, or radiation. While the company’s initial target is aplastic anemiait sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market valued at over $1 billion annually. “Aplastic anemia patients without access to bone marrow transplantation face limited options,” said Dr. David Koos. , “With FDA clearance to begin clin...