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 Insights - Mustang Bio's shares surged 180.7% following the FDA's Orphan Drug designation for its investigational candidate MB-101, aimed at treating rare brain cancers such as recurrent diffuse and anaplastic astrocytoma and glioblastoma [1][4] Group 1: FDA Orphan Drug Designation - The FDA's Orphan Drug designation is granted to drugs for rare diseases affecting fewer than 200,000 people in the U.S., encouraging innovation in unmet medical needs [2] - MB-101, an IL13Rα2-targeted CAR-T cell immunotherapy, is currently in a phase I study for recurrent/refractory GBM patients [1][4] Group 2: Market and Financial Implications - Drugs with Orphan status receive various incentives, including tax credits for clinical study costs, waivers of prescription drug user fees, and seven years of market exclusivity for the designated condition [3] - Year-to-date, Mustang Bio's shares have declined 62.3%, contrasting with a 1.9% decline in the industry [3] Group 3: Clinical Development and Future Plans - MB-101 has shown durable responses in its phase I GBM study, with 50% of patients achieving stable disease or better, including two complete responses lasting 7.5 and over 66 months [7] - Mustang Bio plans to initiate a phase I study of a combination therapy, MB-109, in 2026, pending financing or partnership [8][9] - The company also has another candidate, MB-108, which received Orphan Drug status last year and is being evaluated in a separate phase I study for GBM [6]